[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychological-distress\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychological-distress":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,64,0,25,[9,47,82,116,141,175,206,242,266,294,322,344,378,423,450,478,508,537,563,581,609,638,661,689,715],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100053547","clinical-trial-for-acupuncture-in-adolescents-with-psychological-distress-and-insomnia-100053547",false,"NCT06638450","Clinical Trial for Acupuncture in Adolescents With Psychological Distress and Insomnia","Dense Cranial Electroacupuncture Stimulation Plus Body Acupuncture for Adolescents With Psychological Distress: a Randomized Controlled Trial With Observations on Salivary Oxytocin and Cortisol Changes","Inclusion Criteria:\n\nParticipants will be eligible for this study if they:\n\n1. are experiencing anxiety as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63), and\u002For a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63);\n2. have symptoms that have persistent for more than 3 months;\n3. are able to provide informed consent for participation, and complete treatments and questionnaires as scheduled; and\n4. have no suicidal ideation, as evidenced by \"no\" answers or a score of \\\u003C3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n1. have unstable systemic medical conditions that may limit their participation in the study, for example, severe liver, cardiovascular, or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease; acute infectious disease; or any conditions with unstable vital signs or require intensive hospitalization;\n2. have bipolar or psychotic disorder (e.g. schizophrenia);\n3. have a history of brain injury or surgery;\n4. have alcohol abuse or substance abuse;\n5. are pregnant or in lactation, or intend to conceive;\n6. have heart pacemaker or other metal devices implanted in the body;\n7. have concurrent or use of drug treatment for anxiety\u002Fdepression in the previous 6 months;\n8. have treatment with acupuncture or brain stimulation in the previous 6 months;\n9. have a history of epilepsy;\n10. have a condition of bleeding tendency, or coagulopathy, or currently receiving anti-coagulant treatment; or\n11. involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.","ALL","15 Years","22 Years",{"count":21,"type":22},148,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an assessor-blinded, randomized, MAS-controlled trial. A total of 148 adolescents aged 15-22 years experiencing mild to moderate anxiety or depressive symptoms will be recruited. They will be randomly assigned to DCEAS+BA (n = 74) and MAS (n = 74) for 2 sessions per week for 8 weeks, followed by a 4-week post-treatment observation period. A post-intervention visit will be held at week 12. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) and the Zung Self-Rating Depression Scale (SDS) as additional assessments for anxiety and depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Assessment will be carried out every 4 weeks till week 12, while saliva will be collected at baseline and at the end of the 8 weeks. Salivary oxytocin and cortisol will be analyzed. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the two groups and linear regression will be conducted to examine intercorrelations among clinical improvement and changes in biomarker levels. Subgroup analysis will be conducted to identify specific effects of DCEAS+BA.",[28,29],"Psychological Distress","Insomnia",[31,29,32,33],"Psychological distress","Acupuncture","Adolescent","NOT_YET_RECRUITING","2026-07-08",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":22},"2026-07",{"date":42,"type":22},"2028-09",{"name":44,"class":45},"The University of Hong Kong","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":78,"leadSponsor":80,"locationsCount":46},"100644472","bridging-the-gap-in-psychosocial-care-for-cancer-survivors-100644472","NCT07672314","Bridging the Gap in Psychosocial Care for Cancer Survivors","Bridging the Gap in Psychosocial Care for Cancer Survivors: Integrating Digital Screening With Navigation Call","BRIDGE","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Under oncological care at the USB for ≥9 months\n* Completion of primary cancer treatment (see definition below)\n* Attendance at routine oncological follow-up at USB\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Primary brain tumors\n* Severe cognitive impairment\n* Acute psychiatric symptoms that may impair the participant's ability to provide informed consent or comply with study procedures\n* Insufficient German language skills","18 Years",{"count":57,"type":22},50,[25],"The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.",[61,28,62,63],"Cancer Survivorship","Psycho-Oncology","Supportive Care",[65,66,67,68,69,70,71,72,73],"Cancer survivors","Survivorship care","Digital screening","Psycho-oncology","Psychosocial distress","Patient-reported outcomes (PROs)","Navigation Call","Feasibility study","Acceptability","2026-06-26",{"date":76,"type":38},"2026-06-29",{"date":40,"type":22},{"date":79,"type":22},"2028-05",{"name":81,"class":45},"University Hospital, Basel, Switzerland",{"id":83,"slug":84,"hasResults":12,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":46},"100644982","efficacy-of-vicarious-post-traumatic-growth-intervention-for-nurses-in-emergency-units-100644982","NCT07677527","Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units","Efficacy of Vicarious Post-Traumatic Growth Intervention for Nurses in Emergency Units: A Randomized Controlled Trial","VPTG-RCT","Inclusion Criteria:\n\n1. Registered nurses currently employed in emergency departments.\n2. Minimum six months of emergency department work experience.\n3. Able to read and understand English or Urdu.\n4. Willing to provide informed consent.\n5. Available to participate throughout intervention and follow-up assessments.\n\nExclusion Criteria:\n\n1. Current diagnosis of severe psychiatric disorder requiring intensive treatment.\n2. Current participation in trauma-focused psychotherapy.\n3. Cognitive impairment affecting study participation.\n4. Planned transfer from emergency unit during study period.\n5. Refusal to provide informed consent.",true,{"count":92,"type":22},60,[25],"This randomized controlled trial aims to evaluate the efficacy of a Vicarious Post-Traumatic Growth (VPTG) Intervention among nurses working in emergency units. Emergency nurses are frequently exposed to traumatic events through patient care, which may contribute to vicarious trauma and psychological distress. The intervention is designed to facilitate positive psychological growth, resilience, adaptive coping, and psychological well-being while reducing the adverse impact of indirect trauma exposure. Participants will be randomly assigned to intervention and control groups. Outcomes will be assessed at baseline, post-intervention, and follow-up periods to determine the effectiveness of the intervention in promoting vicarious post-traumatic growth and reducing vicarious trauma among emergency nurses.",[96,28,97,98],"Vicarious Trauma","Post-Traumatic Growth, Psychological","Psychological Well-being in Emergency Unit Nurses",[100,101,102,103,96,104,105],"Vicarious Post-Traumatic Growth","Emergency Nurses","Randomized Controlled Trial","Resilience","Mental Health","Psychological Intervention","RECRUITING","2026-06-24",{"date":109,"type":38},"2026-06-30",{"date":111,"type":38},"2026-03-01",{"date":113,"type":22},"2026-09-01",{"name":115,"class":45},"Fatima Jinnah Women University",{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":90,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":130,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":46},"100641714","italian-yolo-a-web-based-act-mental-health-promotion-intervention-for-university-students-100641714","NCT07654569","Italian YOLO: A Web-Based ACT Mental Health Promotion Intervention for University Students","YOLO","Inclusion Criteria:\n\n* University Students\n\nExclusion Criteria:\n\n* Not enrolled in university",{"count":124,"type":22},1000,[25],"The mental health of university students requires urgent attention, as many students are exposed to increased risk of psychological distress, including symptoms of depression, anxiety, academic stress, and reduced well-being. Although many students experience mental health difficulties, most do not seek help. University counselling and health services may also face increasing demand and limited resources to meet students' needs.\n\nAcceptance and Commitment Therapy (ACT) is a transdiagnostic psychological approach that aims to increase psychological flexibility. Rather than focusing only on symptom reduction or problem solving, ACT helps individuals develop a more flexible relationship with difficult thoughts and emotions, clarify personally meaningful values, and engage in committed action. However, access to traditional psychological interventions may be limited by long waiting lists, time constraints, conflicts with academic schedules, high costs, stigma, and shortages of trained professionals.\n\nWeb-based interventions may help reduce these barriers by providing accessible and flexible support that students can complete privately and at their own pace. Previous research suggests that ACT can be effectively adapted to online formats and may improve mental health and well-being outcomes in university student populations.\n\nThe present study aims to evaluate the effectiveness of the YOLO web-based ACT intervention among students at the University of Bologna. Participants will be allocated to either immediate access to the YOLO program or a waitlist\u002Fdelayed intervention condition. Outcomes will be assessed at baseline, post-intervention, and follow-up assessments, including psychological flexibility, depression, anxiety, psychological well-being, academic performance, academic self-efficacy, resilience, and purpose in life. The study will examine whether changes in psychological flexibility are consistent with the theoretical basis of the program. It will also assess the feasibility, acceptability, and usability of the intervention to inform its potential dissemination in other Italian higher education contexts. In addition, exploratory analyses will examine caregiving responsibilities among students with caregiving roles and assess whether caregiving demands are associated with mental health, well-being, and academic functioning.",[28,128,129],"Psychological Wellbeing","Academic Stress",[131],"Italian YOLO","2026-06-17",{"date":134,"type":38},"2026-06-22",{"date":136,"type":22},"2026-06-11",{"date":138,"type":22},"2028-12-31",{"name":140,"class":45},"University of Bologna",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100642919","steps---stress-training-and-engagement-via-phone-based-systems-100642919","NCT07639697","STEPS - Stress Training and Engagement Via Phone-Based Systems","Mindfulness Training and Respiration Biosignal Feedback - Study 3","Inclusion Criteria:\n\n* Ages 18-30 years of Age\n* Fluent in English\n* Psychological distress\n* Interested in completing smartphone guided training sessions remotely for 14 days\n* Willing and able to wear physiological monitoring equipment\n* Willing to be randomized to one of three conditions\n* Located in the United States\n\nExclusion Criteria:\n\n* Currently pregnant\n* Current or previous diagnosis with psychosis or schizophrenia","30 Years",{"count":150,"type":22},300,[25],"This study will evaluate engagement, usability, and psychological outcomes associated with participation in smartphone-based stress management or mindfulness training program among young adults. The study will compare multiple versions of a digital training program delivered through the Equa mobile application.\n\nParticipants will be individually randomized to one of several app-based training programs using a stratified randomization procedure. Each program consists of guided daily lessons completed over a 14-day period and is designed to support stress management and well-being through structured skill development activities.\n\nPrimary objectives include evaluating user satisfaction and usability of the digital platform and assessing changes in mindfulness-related skills and mental distress over time.\n\nParticipants will:\n\nComplete surveys assessing demographics and psychological well-being at baseline, post-intervention, and one-month follow-up.\n\nComplete a 14-day smartphone-delivered training program consisting of guided lessons while physiological data are collected using wearable sensors.\n\nSome participants may receive additional in-app features designed to support personalized learning or engagement with training lessons.\n\nSome participants will complete brief questionnaires before and after selected lessons to assess short-term changes associated with lesson participation.",[28,154,155,156,157],"Mindfulness Skills","Usability Satisfaction","Program Engagement","Loneliness",[159,160,161,162,163,164],"young adults","mental health","well-being","mindfulness skills","psychological distress","stress management","2026-06-09",{"date":167,"type":38},"2026-06-10",{"date":169,"type":22},"2026-06-05",{"date":171,"type":22},"2027-07",{"name":173,"class":174},"Equa Health","INDUSTRY",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":90,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":184,"conditions":185,"keywords":189,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":46},"100642634","self-help-plus-sh-for-stress-reduction-in-social-service-workers-a-pilot-rct-100642634","NCT07644949","Self-Help Plus (SH+) for Stress Reduction in Social Service Workers: A Pilot RCT","Feasibility and Preliminary Effectiveness of WHO Self-Help Plus (SH+) for Stress Reduction Among Social Service Workers: A Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Currently employed (permanent, contracted, or temporary staff) at an institution under the Istanbul Provincial Directorate of Family and Social Services\n* Able to read and write in Turkish\n* Willing to participate voluntarily\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Imminent suicide risk, screened at baseline (T0) via PHQ-9 item 9; participants scoring 2 or higher are not enrolled and are immediately referred to a mental health professional\n* Active psychosis, severe substance use disorder, or severe intellectual disability\n* An acute medical condition that would preclude participation\n* Planned extended leave (e.g., maternity or unpaid leave) during the study period",{"count":57,"type":22},[25],"This is a two-arm, stratified cluster-randomized controlled pilot trial evaluating the feasibility and preliminary effectiveness of the World Health Organization's Self-Help Plus (SH+) intervention for stress reduction among social service workers employed by the Istanbul Provincial Directorate of Family and Social Services (ASHP). Four institutions (clusters) are randomized 1:1, stratified by service type, to receive either SH+ plus Enhanced Care as Usual (ECAU) or ECAU only, with a target of 50 participants (25 per arm). The primary aim is to assess feasibility indicators (recruitment, session attendance, retention, and acceptability) to inform a future full-scale definitive trial. Preliminary effects on perceived stress and related mental health and well-being outcomes are examined as secondary outcomes.",[186,187,28,188],"Stress, Psychological, Occupational","Stress, Psychological","Burnout, Professional",[190,191,192,193,194,195,196,197,198],"Self-Help Plus","SH+","social service workers","universal prevention","cluster randomized trial","pilot study","Acceptance and Commitment Therapy","Turkey","social care workers",{"date":200,"type":38},"2026-06-12",{"date":40,"type":22},{"date":203,"type":22},"2026-11",{"name":205,"class":45},"Istanbul Medeniyet University",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":214,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":23,"phases":218,"briefSummary":219,"conditions":220,"keywords":229,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":46},"100604558","tag-team---trans-adolescent-group-therapy-100604558","NCT07151079","TAG TEAM - Trans Adolescent Group Therapy","Evaluation of Trans Adolescent Group ThErapy for Alleviating Minority Stress (TAG TEAM): a Randomised Controlled Trial","TAG TEAM","Participants will be enrolled into the RCT only if they meet all the inclusion criteria and none of the exclusion criteria.\n\nInclusion Criteria:\n\n* Identifies as trans, non-binary, or gender diverse\n* Is between the ages of 12 and 17 years inclusive\n* Has completed primary school at the time of enrolment into the study\n* Has current psychological stress symptomology as determined by a score of moderate or above on the DASS-Y\n* Provide informed consent: All participants and parent\u002Flegal guardians must be willing to give informed consent\n\nExclusion Criteria:\n\n* Has current acute suicidal symptomology as determined by a combination of clinical judgement and the results of the Ask Suicide-Screening Questions (ASQ) suicide screening tool (e.g., answer yes to question 5) to determine the risk of suicide (has an active plan and\u002For intent to suicide) at time of screening interview\n* Is actively having treatment with any other group psychological intervention at the time of enrolment into the study\n* Is not proficient in English (as the group Cognitive behaviour therapy (CBT) program will be delivered in English and funds aren't available for interpreters)\n* Previous participation in the feasibility trial\n* Is currently enrolled in tertiary study (e.g., undergraduate university)","12 Years","17 Years",{"count":217,"type":22},142,[25],"This project will study the effect of the TAG TEAM group CBT program on the mental health of trans and gender diverse adolescents. TAG TEAM was co-designed by researchers and clinicians with a group of trans and gender diverse young people to help trans and gender diverse adolescents understand and cope with minority stress. Minority stress includes experiences like discrimination and rejection. TAG TEAM focuses on learning and practicing skills to support mental health and wellbeing. It also includes group discussions and activities with other trans and gender diverse young people. TAG TEAM groups are run by a psychologist and a trans peer facilitator. A trans peer facilitator is a trans and gender diverse person who is there to share their experience of being trans and to support participants in the group sessions.",[221,73,28,222,223,224,225,226,227,228],"Minority Stress","Anxiety","Depression in Adolescence","Coping","Wellbeing","Pride","Internalised Stigma","Community Connection",[33,230,231,225,232,233],"Trans and gender diverse","Minority stress","Group Therapy","CBT","2026-06-04",{"date":169,"type":38},{"date":237,"type":38},"2026-05-21",{"date":239,"type":22},"2027-03",{"name":241,"class":45},"Murdoch Childrens Research Institute",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":249,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":264,"locationsCount":46},"100546025","change-my-story-task-shifted-mental-health-intervention-100546025","NCT06389565","Change My Story Task Shifted Mental Health Intervention","Change My Story: Pilot Randomized Clinical Trial of Change My Story Among Young Persons Living With HIV and Depression","Inclusion Criteria:\n\n* HIV-positive\n* age 16-24 years\n* self-reported proficiency in reading and understanding English.\n* PHQ9 score of 8-17 and impairment in functioning (consistent with clinical depression)\n\nExclusion Criteria:\n\n* pregnant or nursing\n* in care and on ART for \\\u003C6 months\n* history of- or positive assessment for- bipolar or psychotic disorder.","16 Years","24 Years",{"count":252,"type":22},80,[25],"Psychological distress and depression are common among young people living with HIV (Y-PLWH) and negatively impact medication adherence and disease control. In low- and middle-income countries, this problem is compounded by the lack of trained mental health professionals on the provider side and the requirement of frequent clinic-based visits imposing greater cost, inconvenience, and stigma for patients. Change My Story, is a theory-grounded, interactive narrative game designed to address the key drivers of depression and psychological distress among Y-PLWH in Nigeria. This pilot hybrid implementation-effectiveness randomized controlled trial (RCT) will compare Change My Story combined with PST to PST alone among 80 Y-PLWH with depression or psychological distress.",[256,257,28],"Hiv","Depression","2026-05-26",{"date":260,"type":38},"2026-05-28",{"date":262,"type":38},"2025-06-01",{"date":109,"type":22},{"name":265,"class":45},"Massachusetts General Hospital",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":249,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":23,"phases":277,"briefSummary":278,"conditions":279,"keywords":280,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":4},"100639289","investigating-the-cost-effectiveness-of-an-online-social-therapy-platform-enyoy-for-young-people-aged-16-25-on-mental-healthcare-waiting-lists-100639289","NCT07594756","Investigating the (Cost-)Effectiveness of an Online Social Therapy Platform (ENYOY) for Young People Aged 16-25 on Mental Healthcare Waiting Lists","ENgage YOung People earlY: the Next Steps","ENYOY:nextstep","Inclusion Criteria:\n\n* Age 16-25 years\n* On a waiting list for mental healthcare\n* Able and willing to consent\n* A score of 10 or higher on the CORE-10 questionnaire\n* Have personal and private access to a computer, smartphone or tablet.\n* Ability and willingness to nominate an emergency contact person, such as a close family member\n\nExclusion Criteria:\n\n* Insufficient command of the Dutch language\n* Present with acute suicidal behavior or imminent risk of harm to self\n* If their psychiatric symptoms are due to an organic cause\n* Prior exposure to ENYOY or MOST","25 Years",{"count":276,"type":22},225,[25],"This study, run by Amsterdam UMC in the Netherlands, looks at whether an online mental health platform called ENYOY can help improve psychological distress in young people (16-25) who are waiting for mental health care. Young people in the Netherlands aged 16 to 25 can take part if they are experiencing mental health problems, and are currently on a waiting list for mental healthcare. The study lasts 12 months. During this time, participants fill in questionnaires four times (at the start, at 3-months, 6-months, and 12-months). After joining the study, participants are randomly placed into one of two groups:\n\n* Intervention group: receives access to the ENYOY platform plus care-as-usual.\n* Control group: receive care-as-usual. Young people in the intervention group can use the platform for the duration of the study period, with three months of guidence by a coach and\u002For peer with lived experience with mental health complaints. The platform includes activities based on proven psychological methods. These activities help with things like low mood, anxiety, sleep problems, and confidence. They also get support from a coach and\u002For a peer (someone who has experienced mental health problems themselves), and access to a safe online community where young people can talk, share experiences, and support each other. The community is moderated to keep it safe and supportive. Taking part may help young people feel psychological stress and improve their mental health. There are no known risks from taking part in this study.\n\nParticipant recruitment will take place from May 2026 to December 2027. Final follow-up assessments are expected to be completed by December 2028. The study is funded by ZonMw. For questions, you can contact Sascha Struijs (s.y.struijs@vu.nl), or Fenna Hellegers (f.hellegers@amsterdamumc.nl)",[28],[31,281,282,283,284,285],"Young people","DMHI","ENYOY","MOST","Waiting list","2026-05-13",{"date":288,"type":38},"2026-05-19",{"date":290,"type":22},"2026-05-18",{"date":138,"type":22},{"name":293,"class":45},"Academisch Medisch Centrum - Amsterdam UMC Research BV",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":4,"eligibilityCriteria":300,"healthyVolunteers":90,"sex":301,"minAge":55,"maxAge":274,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":307,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":46},"100639135","effectiveness-of-a-brief-gratitude-writing-intervention-on-state-optimism-state-gratitude-and-psychological-distress-100639135","NCT07588451","Effectiveness of a Brief Gratitude Writing Intervention on State Optimism, State Gratitude, and Psychological Distress","Effectiveness of a Brief Gratitude Writing Intervention on State Optimism, State Gratitude, and Psychological Distress Among Female University Students","Inclusion Criteria:\n\n* Female undergraduate students\n* Students scoring mild to moderate distress on Kessler Psychological Distress scale\n\nExclusion Criteria:\n\n* Female university students enrolled in psychology programs\n* Students with physical disability\n* Students who are already in therapy","FEMALE",{"count":303,"type":22},96,[25],"The goal of the study is to investigate the effectiveness of brief writing interventions on state optimism, state gratitude and psychological distress among female university students. There are three groups; gratitude writing group where participants are required to write about the things they are grateful for, expressive writing group where participants are required to write about their deepest feelings and thoughts from last week and a control group where participants just write about the tasks they completed in the past week.",[28],[308,309,310,311,163,312],"gratitude writing","expressive writing","state optimism","state gratitude","brief interventions","2026-05-10",{"date":315,"type":38},"2026-05-14",{"date":317,"type":22},"2026-06-20",{"date":319,"type":22},"2026-08",{"name":321,"class":45},"Kinnaird College for Women",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":23,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":46},"100623115","prevalence-of-diabetes-related-distress-among-patients-living-with-type-2-diabetes-in-a-university-hospital-center-and-identification-of-its-associated-factors-100623115","NCT07392437","Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.","DIAMIND","Inclusion Criteria:\n\n* Adults (age ≥ 18 years).\n* Diagnosed with type 2 diabetes according to national (HAS) criteria, whether newly diagnosed or longstanding, with or without chronic complications, and with no restriction regarding HbA1c level. Managed for type 2 diabetes in the endocrinology department of Nice University Hospital (conventional hospitalization, day hospital, or outpatient consultation).\n* Able to understand the study information and to complete the self-administered questionnaires.\n* Affiliated to the French social security system.\n* Has not objected to participation in the study (non-opposition procedure).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnant woman.\n* Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes).\n* Haemochromatosis.\n* Cystic fibrosis.\n* Current treatment with one of the following hyperglycaemic therapies: oral corticosteroids, immunosuppressive drugs, dopaminergic agonists, interferon-alpha, or protease inhibitors.\n* History of partial or total pancreatectomy.\n* Ongoing genetic work-up for atypical diabetes.\n* Non-French-speaking patient.\n* Major neurocognitive disorder or physical\u002Fmental disability preventing completion of the questionnaires.\n* Adult under legal protection (guardianship or curatorship).\n* Refusal or subsequent withdrawal of non-opposition.\n* Any later paraclinical result finally revealing a type of diabetes other than type 2 diabetes.",{"count":330,"type":22},246,[25],"Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment.\n\nThis single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.",[334,28],"Diabetes Mellitus","2026-05-06",{"date":337,"type":38},"2026-05-07",{"date":339,"type":38},"2026-04-15",{"date":341,"type":22},"2027-01-15",{"name":343,"class":45},"Centre Hospitalier Universitaire de Nice",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":274,"enrollmentInfo":352,"targetDuration":4,"studyType":23,"phases":354,"briefSummary":355,"conditions":356,"keywords":362,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":377},"100625814","misapsy-childhood-maltreatment-food-insecurity-psychological-distress-and-professional-integration-among-socioeconomically-disadvantaged-young-adults-100625814","NCT07427524","MISAPSY: Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults","Psychosocial Intervention With Precarious Young People: a Comparative Longitudinal Study on Psychological Distress and Food Insecurity","PRESPA","Inclusion Criteria:\n\n* Be aged 18 to 25 years\n* Be supported by a Mission Locale in Paris as part of a social and\u002For professional integration program\n* Voluntarily participate in the study after receiving clear information and signing an informed consent form\n* Experiencing severe food insecurity (positive response to item 8 of the FIES)\n* Experiencing significant psychological distress, defined by: PHQ-9 score \\> 15; GAD-7 score \\> 10\n* Have been exposed to at least one adverse childhood experience, identified via the CTQ-SF (Childhood Trauma Questionnaire - Short Form).\n\nExclusion Criteria:\n\n* Being unable to provide informed consent due to impaired comprehension or communication skills\n* Currently receiving psychiatric care for an acute or chronic mental illness requiring regular specialized treatment\n* Experiencing a social or medical emergency incompatible with the study (e.g., unstable emergency housing, acute suicidal crisis, ongoing hospitalization)\n* Being incarcerated, under guardianship or curatorship without specific legal authorization to participate in research\n* Having previously participated in a similar study or currently being engaged in a structured psychological intervention protocol\n* Having insufficient command of the French language, preventing comprehension of instructions, questionnaires, or interviews.",{"count":353,"type":22},70,[25],"The MISAPSY study (Childhood Maltreatment, Food Insecurity, Psychological Distress and Professional Integration Among Socioeconomically Disadvantaged Young Adults) aims to model the complex interrelations between child maltreatment, trauma exposure, food insecurity, and psychological distress among precarious young adults enrolled in French youth employment and social integration services (Mission Locale).\n\nAdopting a methodology structured around three complementary components, this study consists of: (1) a cross-sectional survey to identify key associations ; (2) a qualitative study based on semi-structured interviews exploring psychologists' subjective experiences, and (3) a longitudinal comparative interventional study involving two different support programs to assess and compare the impact of these interventions on participants' food insecurity and psychological well-being.\n\nUsing a multi-phase design, MISAPSY seeks to move beyond linear risk-factor models by adopting a systemic and network-based approach to mental health and social vulnerability. The study integrates quantitative analyses, including network analyses, qualitative exploration of professional practices, and comparative longitudinal intervention to inform more holistic, equitable, and transferable models of care for vulnerable young adults.",[357,358,359,28,360,361],"Trauma and Stress-related Disorders","Food Insecurity","Child Maltreatment","Depression Symptoms","Anxiety Symptoms",[358,363,159,364,365,163,366,367],"Mental health","trauma","adverse childhood experience","precarity","mixed-methods","2026-04-28",{"date":370,"type":38},"2026-05-05",{"date":372,"type":22},"2026-07-01",{"date":374,"type":22},"2027-06",{"name":376,"class":45},"University of Lorraine",6,{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":90,"sex":17,"minAge":384,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":23,"phases":388,"briefSummary":389,"conditions":390,"keywords":404,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":422},"100636162","develop-and-evaluate-an-artificial-intelligence-assisted-prehabilitation-program-for-returning-to-work-and-cost-effectiveness-analysis-in-patients-with-oral-cancer-100636162","NCT07562100","Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer","Inclusion Criteria:\n\n* Adult (\\> 20 years old and younger than 70 years old)\n* Newly diagnosed as OC and scheduled to receive cancer-related treatment\n* Able to use Mobile phone\n* Willing to sign an informed consent form after receiving a detailed explanation of the study's aims and procedures\n* Healthcare professionals involved in patients' care, including doctors, nurses, case managers, dietitians, rehabilitation therapists, and psychologists\n* Family members who are primary caregivers of the participating patients, engaged in different stages of medical care\n\nExclusion Criteria:\n\n* Risk populations for walking or performing exercise\n* Patients with cognitive impairment or psychiatric diseases","20 Years","70 Years",{"count":387,"type":22},650,[25],"The goal of this clinical trial is to develop and evaluate an Artificial Intelligence Assisted Prehabilitation Program (AI APP) for returning to work and cost-effectiveness analysis in patients with oral cancer (OC). The main questions it aims to answer are:\n\n* What kinds of needs are related to returning to work (RTW) in patients with OC from diagnosis to survival that we can incorporate into the development of AI APP to assist this population ?\n* How is the effect of the AI APP that based on findings from the first question for patients with OC on physical and psychological distress, fear of recurrence, self-efficacy in coping with cancer, communication, motor function, quality of life, and RTW?\n* How is the effect of the RTW AI prediction model to identify high-risk groups ? And how is the comprehensive cost effectiveness of benefits and quality of life of the AI APP for OC population?\n\nResearchers will compare patients without using AI APP to see if the AI APP works to assist with coping physical and psychological distress, communication, motor function, quality of life, and RTW issues for individuals with OC?\n\nParticipants will:\n\n* Be asked to fulfill a structural questionnaire, or engage in a semi-structured one-by-one interview or a focus group to assess their physical, psychological, and social support needs in the first stage.\n* Be invited to participant the pilot testing of AI APP in the second stage.\n* Be provided and trained by 3-month AI APP for 3 months or cared as usual in the third stage.\n* Complete a structural questionnaire and follow up one year, including the baseline (before using the AI app) and at 1-2 weeks, 3 months, 6 months, 9 months, and 12 months after the baseline.\n* Engage in one-by-one interview or a focus group to assess user experiences of the AI APP.",[391,28,392,393,394,395,396,397,398,399,400,401,402,403],"Oral Cancer","Communication Aids for Disabled","Physiotherapy","Return to Work","Prehabilitation","Physical Symptom Distress","Motor Function","Rehabilitation","Quality of Life","Cost Effectiveness","Artifical Intelligence","Prediction Model","Case Management, APP(Application)",[405,394,391,28,392,393,395,406,407,398,408,409,410,411],"Artificial Intelligence","Physical symptom distress","motor function","Quality of life","Cost effectiveness","prediction model","case management, APP(Application)","2026-04-24",{"date":414,"type":38},"2026-05-01",{"date":416,"type":38},"2024-09-27",{"date":418,"type":22},"2029-12-01",{"name":420,"class":421},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",5,{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":432,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":449},"100507142","phase-2-lysergic-acid-diethylamide-lsd-in-palliative-care-100507142","NCT05883540","Lysergic Acid Diethylamide (LSD) in Palliative Care","Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)","LPC","Inclusion Criteria:\n\n* Age ≥ 22 years.\n* Advanced or End-stage fatal disease of any cause with a life expectancy ≥ 12 weeks and ≤ 2 years\n* Sufficient understanding of the study procedures and risks associated with the study.\n* Participants must be willing to adhere to the study procedures and sign the consent form.\n* Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD administration.\n* Participants must complete an actual \"Emergency Medical Directive\"\n* Participants with central nervous system (CNS) involvement of cancer are eligible if the following apply:\n\n  * treated and stable CNS lesion(s) OR untreated but asymptomatic\u002Fstable lesions, defined as clinically and\u002For radiologically stable for ≥ 4 weeks before screening\n  * no seizures within ≥ 4 weeks; if on antiepileptic medication: stable dose ≥ 4 weeks and no relevant drug-drug interactions expected\n  * no requirement for high-dose corticosteroids, defined as ≤10 mg prednisone equivalent per day on a stable or decreasing dose\n  * no leptomeningeal metastases\n  * no concomitant therapeutic anticoagulation\n\nExclusion Criteria:\n\n* Life expectancy \\< 12 weeks\n* Known hypersensitivity to LSD\n* Requiring ongoing concomitant therapy with a psychoactive prescription drug which might interfere with the study drug, and unable or unwilling to comply with the washout period.\n* Current use of a potent drug CYP2D6 inhibitor\n* Women who are pregnant or nursing or intend to become pregnant during the course of the study.\n* Somatic disorders including CNS involvement of cancer, untreated epilepsy with a history of generalized grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects.\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant.\n* Participation in another study with an investigational drug within the 30 days preceding and during the present study\n* concomitant diagnosis of past or present psychotic disorder, first-degree relative with psychotic disorders\n* concomitant diagnosis of past or present bipolar disorder\n* current delirium\n* substance use disorder (within the last 2 months, except nicotine, opioids used for analgesia, and benzodiazepine treatment for anxiety).\n* Weight \\< 45 kg\n* Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator.\n* CNS involvement of cancer if\n\n  * CNS disease is unstable or high-risk, including clinically and\u002For radiologically progressive lesions, signs of raised intracranial pressure, radiologically uncontrolled edema, need for escalating corticosteroid doses, or any neurological condition judged to pose too excessive risk.\n  * CNS-directed therapy (surgery and\u002For radiation) within ≤ 4 weeks",{"count":92,"type":22},[433],"PHASE2","Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects.\n\nObjective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an advanced or end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.",[436,437,222,257,438,28,399,439,440,441],"Palliative Care","Pain","Demoralization","Caregiver Burden","Fear of Death","Existential Distress","2026-04-23",{"date":444,"type":38},"2026-04-29",{"date":446,"type":38},"2024-06-09",{"date":79,"type":22},{"name":81,"class":45},4,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":249,"maxAge":4,"enrollmentInfo":457,"targetDuration":4,"studyType":23,"phases":459,"briefSummary":460,"conditions":461,"keywords":465,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":46},"100575764","boosting-refugee-integration-through-psychological-intervention-100575764","NCT06776523","Boosting Refugee Integration Through Psychological Intervention","BRIGHT","The inclusion criteria for participating in the study are:\n\n* refugees and asylum seekers (RAS) aged 16 or older;\n* residing in one of the participating local sites (Swiss municipalities, namely, Gemeinden, and transitional asylum centers, namely, Durchgangszentren) where PM+ is offered and which gave their consent for participation in the RCT;\n* speaking at least one of the following 12 languages: German, English, French, Arabic, Farsi, Kurdish, Tigrinya, Turkish, Ukrainian, Russian, Tamil, and Pashto;\n* obtaining a score of 20 or higher on the Kessler Psychological Distress Scale (K10; Kessler et al., 2002), a brief clinically validated screening questionnaire that assesses general psychological distress in the past 30 days. A score equal to or higher than 20 is used as an indication of moderate to high levels of psychological distress.\n\nThe exclusion criteria for participating in the study are:\n\n* significant cognitive or neurological impairment measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);\n* acute medical conditions or severe mental disorders (e.g., psychotic or substance-abuse disorders) measured through specific tools developed by the WHO and integrated into the PM+ manual (impairment questionnaire);\n* acute risk of suicide as measured by the Suicidal Ideation Attribution Scale (SIDAS; van Spijker et al., 2014) and the Thoughts of Suicide Questionnaire (World Health Organization WHO, 2016).",{"count":458,"type":22},1200,[25],"Refugees and asylum seekers (RAS) face numerous stressors and adversities which put them at risk for developing mental health problems. However, access to adequate mental health care in host countries is limited. To address this problem, the World Health Organization (WHO) introduced Problem Management Plus (PM+), a short, low-intensity psychological intervention administered by non-professionals, aiming to alleviate common mental disorders among crisis-affected communities.\n\nThe present study aims at expanding the existing PM+ intervention by providing additional booster sessions and homework reminders while evaluating its effectiveness and implementation in the public health system.",[28,462,463,464],"PTSD","Trauma","Common Mental Health Problems",[466,28,467,468],"Problem Management Plus","Mental Health Care","Refugees","2026-04-21",{"date":471,"type":38},"2026-04-27",{"date":473,"type":38},"2025-01-16",{"date":475,"type":22},"2027-09",{"name":477,"class":45},"University of Zurich",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":492,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":4},"100634865","digital-lifestyle-intervention-for-mental-health-among-migrants-randomized-controlled-trial-100634865","NCT07545239","Digital Lifestyle Intervention for Mental Health Among Migrants: Randomized Controlled Trial","Digital Lifestyle Intervention to Improve Mental Health Among Migrants: A Randomized Controlled Trial With a Nested Pilot Study","LIFT-RCT","Inclusion Criteria:\n\n* Migrant living in Sweden\n* Age 18 years or older\n* Moderate psychological distress (PHQ-9 ≥10, GAD-7 ≥10, or PSS-4 ≥8)\n* Ability to read and write in easy Swedish or English\n* Access to a computer or device with internet connection\n* Motivation to engage in lifestyle change\n* Ability to provide digital informed consent\n\nExclusion Criteria:\n\n* Severe psychiatric disorder\n* Severe depression or suicide risk\n* Severe medical illness\n* Alcohol dependency\n* Initiation or adjustment of psychotropic medication within the last 8 weeks",{"count":487,"type":22},240,[25],"Migrant populations experience elevated levels of psychological distress while facing barriers to accessing mental health care. Lifestyle factors such as physical activity, sleep, diet, and social engagement are closely linked to mental health and represent promising targets for preventive interventions. Digital delivery may increase accessibility and reduce structural barriers to care.\n\nThe aim of this study is to evaluate the feasibility, acceptability, and efficacy of a culturally and linguistically adapted digital lifestyle intervention for migrants experiencing moderate psychological distress in Sweden. Participants (N = 240) will be randomized to an 8-week digital lifestyle intervention or to a wait-list control receiving a general lifestyle module. A nested pilot study (N = 30) will first assess feasibility and acceptability.\n\nOutcomes include general psychological health, quality of life, depression, anxiety, stress, and lifestyle behaviors. Assessments will be conducted at baseline, post-treatment (8 weeks), 2-month follow-up, and 6-month follow-up.",[491,257,222,28],"Mental Health Disorder",[493,494,495,496,497,233,498],"Migrant mental health","Lifestyle intervention","Digital intervention","Prevention","Randomized controlled trial","Public health","2026-04-16",{"date":501,"type":38},"2026-04-22",{"date":503,"type":22},"2026-04",{"date":505,"type":22},"2028-10",{"name":507,"class":45},"Karolinska Institutet",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":517,"briefSummary":518,"conditions":519,"keywords":523,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":531,"startDateStruct":532,"completionDateStruct":533,"leadSponsor":535,"locationsCount":46},"100634918","single-arm-monocentric-pilot-feasibility-study-on-an-interactive-virtual-reality-program-in-20-complex-in-clinic-palliative-care-patients-100634918","NCT07545928","Single Arm, Monocentric, Pilot Feasibility Study on an Interactive Virtual Reality Program in 20 Complex In-clinic Palliative Care Patients","ZENCTUARY_VR+","Inclusion Criteria:\n\n* Patient ≥ 18 years old, hospitalized at the USP - HUS\n* Estimated life expectancy ≥ 1 month (Pronopall score based on clinical data).\n* Montreal Cognitive Assessment (MoCA) scale score ≥ 26.\n* Able to understand the objective and risks of the study\n* VRISE score ≤ 25 after the VR familiarization procedure\n* Affiliation with the Social Security system or beneficiary of such social protection.\n* Signed consent from, able to understand and complete the questionnaires in French.\n\nExclusion Criteria:\n\n* Patients with psychiatric disease\n* Patients under court protection\n* Uncontrolled epilepsy\n* Visual impairments (lack of binocular vision, blindness) and\u002For hearing impairments (deafness) preventing the use of virtual reality",{"count":516,"type":22},20,[25],"Palliative care patients frequently face a \"symptom cluster\" of pain (up to 96%), fatigue (up to 90%), and anxiety (up to 79%), which severely degrades their quality of life in their final months.The study is built on the concept of passive exposure therapy (VREP), which engages multiple senses to distract the brain from pain signals. By creating an \"immersive distraction\" or a \"flow state,\" VR can activate the brain's reward networks and reduce activity in areas associated with pain perception. Unlike most existing VR research in palliative care which uses \"passive\" VR (like watching a 360-degree video), this study uses interactive VR. Patients can perform simple actions-like grabbing or dropping virtual objects-within a calming natural environment, which may better support their sense of autonomy and dignity. Because this is a pilot study, the \"Go\u002FNo-Go\" decision for future larger trials depends on a strict composite of three factors:\n\n* Adherence: The patient must complete at least 11 out of 14 planned daily sessions.\n* Duration: Each session must average at least 7.5 minutes of usable VR exposure.\n* Tolerance: The patient must experience no device-related serious adverse events and maintain a high average tolerance score (VRISE score ≥ 25).",[436,520,222,521,522,28],"Refractory Pain","Depression Disorders","Fatigue, Mental",[524,525,526,527,528,529,530],"palliative care","end-of-life care","refractory pain","Interactive Virtual Reality","Immersive Technology","Virtual Reality Exposure Therapy (VRET)","Cybersickness in Palliative Care",{"date":501,"type":38},{"date":113,"type":22},{"date":534,"type":22},"2027-03-01",{"name":536,"class":45},"University Hospital, Strasbourg, France",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":546,"briefSummary":547,"conditions":548,"keywords":549,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":558,"leadSponsor":560,"locationsCount":422},"100631981","testing-an-adaptive-intervention-for-peer-supported-mobile-health-for-primary-care-veterans-with-psychological-distress-100631981","NCT07507747","Testing an Adaptive Intervention for Peer-Supported Mobile Health for Primary Care Veterans With Psychological Distress","Peer mHealth","Inclusion Criteria:\n\n* Veteran enrolled in primary care at one of 3 VA facilities (Philadelphia, PA; Ann Arbor, MI; and Bedford, MA)\n* clinically significant psychological distress on at least one DASS-21 subscale (Depression =\\> 10, Anxiety =\\> 8, Stress =\\> 13)\n\nExclusion Criteria:\n\n* symptoms that may preclude active engagement in the intervention such as gross cognitive impairment or current symptoms of mania or psychosis\n* suicide risk as measured by the P4 Suicide Assessment\n* plan to engage in psychotherapy during the intervention period\n* started or changed the dose of a psychotropic medication in the last two months\n* voice a preference to be directly referred to mental health specialty care",{"count":545,"type":22},384,[25],"Many Veterans experience psychological distress including depression, PTSD, anxiety and problems with sleep and anger. Services to address these problems need to be easy for Veterans to access. VA mobile health applications (mHealth apps) that teach skills to manage psychological distress are widely available. However, Veterans rarely use these apps enough to experience health benefits. Peer specialists are VA employees who are trained to use their lived experiences in mental health recovery to help other Veterans. Peers can provide support and accountability to Veterans as they use mHealth apps. Peers working in VA primary care settings are easily accessible to Veterans who receive VA services. This study aims to improve the health of Veterans by testing the effectiveness of peer-supported mHealth in reducing psychological distress. It will also test how much peer support Veterans need to improve their health with using mHealth apps.",[28],[550,551,552,553,163],"peer support","mHealth","Veterans","SMART design","2026-04-07",{"date":556,"type":38},"2026-04-13",{"date":372,"type":22},{"date":559,"type":22},"2030-04-30",{"name":561,"class":562},"VA Office of Research and Development","FED",{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":17,"minAge":214,"maxAge":215,"enrollmentInfo":569,"targetDuration":4,"studyType":23,"phases":570,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":578,"leadSponsor":579,"locationsCount":46},"100516259","development-and-testing-of-imhere4u-a-digital-suicide-prevention-intervention-for-cyberbullied-adolescents-100516259","NCT06002191","Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents","Inclusion Criteria:\n\n* English-speaking\n* access to a phone or device capable of text messaging\n* past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization and Perpetration Scale and\u002For presence of online discrimination measured by a modified version of a discrimination measured developed as part of the Adolescent Brain and Cognitive Development (ABCD) study\n* past 3-month history of suicidal risk, including: psychological distress (\\>13 on the 6-item Kessler Psychological Distress Scale) and\u002For suicidal ideation or behavior (via the Columbia Suicide Severity Rating Scale)\n\nExclusion Criteria:\n\n* intellectual challenges, low literacy levels, or other conditions that might inhibit adolescents' ability to effectively engage with Flourish (reported by parents and, if needed, confirmed through the age-appropriate Wechsler Intelligence scale)\n* acuity levels suggesting need for a higher level of care (e.g., inpatient hospitalization) or referral for emergency services",{"count":252,"type":22},[25],"The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents.\n\nThe specific aims are to:\n\nAim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \\>35% underserved youth).\n\nH2a. Primary outcome: Feasibility will be evidenced by recruitment\u002Fretention rates \\> 80% and imHere4U engagement \\> 70%.\n\nH2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period.\n\nExploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \\>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \\> 6.",[28,573],"Suicidal Ideation","2026-04-02",{"date":554,"type":38},{"date":577,"type":38},"2023-11-21",{"date":319,"type":22},{"name":580,"class":45},"University of Pittsburgh",{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":586,"acronym":4,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":588,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":595,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":603,"completionDateStruct":604,"leadSponsor":606,"locationsCount":608},"100629993","feasibility-and-efficacy-of-the-emdr-toolbox-method-in-cancer-patients-100629993","NCT07481890","Feasibility and Efficacy of the EMDR Toolbox Method in Cancer Patients.","Feasibility and Efficacy of an EMDR Psychotherapeutic Intervention With Additional Procedures (EMDR Toolbox Method) in Improving the Psychological Well-Being of Patients Diagnosed With Oncological Disease: A Randomized Study.","Inclusion Criteria:\n\n* Clinical stage of the tumor: Stage I, II (TNM classification)\n* Age ≥ 18 years \\\u003C=65\n* Conditions enabling correct implementation of the proposed program (ability to complete questionnaires)\n* Written informed consent\n\nExclusion Criteria:\n\n* Psychiatric or other disorders that may impair the ability to provide informed consent.","65 Years",{"count":590,"type":22},46,[25],"The incidence of adverse childhood experiences (ACEs) is significantly elevated in patients affected by organic diseases (Riedl, 2020). Adverse childhood experiences include life events such as physical, emotional, and sexual abuse; exposure to domestic violence; abandonment; and physical and emotional neglect occurring during early stages of life. One of the primary and most extensively studied mechanisms through which ACEs appear to influence the development of organic diseases across the lifespan is dysregulation of cortisol levels, which acts as a key mediator of increased macro- and microcellular inflammatory processes.\n\nIn rhis context, it is important to integrate the standard triage and psychological distress screening interventions routinely provided by psychologists working in clinical liaison psychology services with specialized, evidence-based psychotherapeutic treatments delivered by appropriately trained professionals. Among the range of evidence-based psychotherapies currently available, Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy-hereafter referred to as EMDR-was recognized by the World Health Organization (WHO) in 2013 and reaffirmed in 2024 as one of the treatments of choice for trauma and the psychophysiological consequences of adverse events.\n\nSince 2015, Manuela Spadoni has systematized the empirical evidence, theoretical concepts, the parts model, and the operational tools of the additional EMDR procedures introduced by Jim Knipe beginning in 2001 into a structured psychotherapeutic approach known as the EMDR Toolbox method. This method appears to be particularly well suited for treating individuals whose clinical history is characterized by multiple adverse experiences.\n\nThe present randomized trial aims to evaluate the feasibility and efficacy of the EMDR Toolbox Method (ETM) in patients diagnosed with oncological disease.",[594,28],"Cancer",[594,596,597,598,599,600],"Eye Movement Desensitization and Reprocessing","Psychosomatics","EMDR Toolbox Method","Trauma-focused psychotherapy","Psychotherapy","2026-03-27",{"date":574,"type":38},{"date":601,"type":38},{"date":605,"type":22},"2027-12-31",{"name":607,"class":45},"Lega Cancro Ticino",2,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":616,"maxAge":617,"enrollmentInfo":618,"targetDuration":4,"studyType":23,"phases":619,"briefSummary":620,"conditions":621,"keywords":622,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":608},"100631887","flourish-in-schools-pilot-study-100631887","NCT07506525","Flourish in Schools Pilot Study","Adaptation and Implementation of Flourish Within Schools: Strengthening Suicide Prevention Services for Adolescents Experiencing Online Victimization","Inclusion Criteria:\n\n* 11-21 years old\n* English-speaking\n* have access to a cell phone or tablet that can send\u002Freceive SMS text messages\n* identified as a student who could benefit from the program by a school staff member - OR - screened eligible based on experiencing cyberbullying and suicide risk factors in the past 3 months\n* past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization Scale and\u002For presence of online discrimination as measured by a modified measure from the Adolescent Brain and Cognitive Development (ABCD study)\n* past 3-month history of suicide risk factors, assessed by: psychological distress (\\>13 on the 6-item Kessler Psychological Distress Scale) and\u002For suicidal ideation or behavior (via the Columbia Suicide Severity Rating Scale)\n\nExclusion Criteria:\n\n* if a student has a condition that might inhibit their ability to effectively engage with Flourish (e.g., intellectual challenges or low literacy levels)\n* if a students' level of acuity would suggest a higher level of care or referral to emergency services\n* if a school staff judges the intervention is not appropriate for the student","11 Years","21 Years",{"count":516,"type":22},[25],"This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools.\n\nSpecifically, the study aims to:\n\n1. Examine if Flourish is effective and can be feasibly delivered within schools among middle and high school students who are experiencing cyberbullying and suicide risk factors. Feasibility will be evidenced by recruitment and retention rates to the study (\\> or = 80%) and use of Flourish at least weekly among 80% of youth. Effectiveness will be evidenced by students reporting improvements in psychological distress and suicidal thoughts over the 3-month follow-up period.\n2. Understand barriers or facilitators to Flourish's adoption within schools. We will conduct exit interviews and brief surveys with school personnel to inform optimal strategies for implementing Flourish within schools",[28,573],[623,624,625,626,627,628],"cyberbullying","suicide","adolescents","digital","schools","social media","2026-03-26",{"date":631,"type":38},"2026-04-01",{"date":633,"type":38},"2026-03-14",{"date":635,"type":22},"2027-01",{"name":637,"class":45},"Candice Biernesser",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":645,"targetDuration":4,"studyType":23,"phases":647,"briefSummary":648,"conditions":649,"keywords":652,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":658,"leadSponsor":659,"locationsCount":46},"100631399","fighting-the-fear-of-cancer-recurrence-in-cancer-survivors-a-pilot-study-on-the-effectiveness-of-metacognitive-therapy-100631399","NCT07500168","Fighting the Fear of Cancer Recurrence in Cancer Survivors: A Pilot Study on the Effectiveness of Metacognitive Therapy","MCT-FCR","Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Patients with cancer classified as stage I, II, or III according to the TNM staging system who have completed primary cancer treatment.\n3. Ability to understand and read Chinese, with no significant cognitive impairment.\n4. A score of 13 or higher on a validated measure of fear of cancer recurrence.\n\nExclusion Criteria:\n\n1. Individuals with severe psychiatric disorders.\n2. Individuals who have difficulty communicating in Mandarin. -",{"count":646,"type":22},120,[25],"This study aims to evaluate the effectiveness of metacognitive therapy (MCT) in reducing fear of cancer recurrence (FCR) among cancer survivors.\n\nWith advances in cancer treatment, more patients are surviving cancer. However, many survivors continue to experience fear of cancer recurrence, which can affect their emotional well-being, quality of life, and ability to return to normal daily activities.\n\nIn this study, participants will receive a structured psychological intervention adapted from the ConquerFear program. This program has been modified to better fit local cultural needs.\n\nParticipants will be randomly assigned to receive either metacognitive therapy or relaxation therapy.\n\nThe study will compare the effects of these interventions on reducing fear of cancer recurrence, as well as their impact on emotional distress and quality of life.\n\nThe results of this study may help develop effective psychological treatments to support cancer survivors in managing fear of recurrence and improving overall well-being.",[650,651,28],"Fear of Cancer Recurrence","Cancer Survivors",[650,651,68,653,102,222,257,399],"ConquerFear","2026-03-24",{"date":656,"type":38},"2026-03-30",{"date":503,"type":22},{"date":138,"type":22},{"name":660,"class":45},"Koo Foundation Sun Yat-Sen Cancer Center",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":90,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":23,"phases":671,"briefSummary":672,"conditions":673,"keywords":675,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":688},"100562675","self-help-plus-for-distress-in-university-students-100562675","NCT06606249","Self-Help Plus for Distress in University Students","Randomized Trial of a Brief, Transdiagnostic, Guided Self-help Intervention for University Students Who Are Behind on Their Coursework and Experience Distress","SSH+","Inclusion Criteria:\n\n* University students across all years of higher education (i.e., bachelor and masters), enrolled in any degree course, starting from the second semester of the 1st year\n* Currently behind coursework by at least 3 exams, including: exams failed, for which the obtained grade was not confirmed by the student (i.e., confirming the grade is mandatory in the Italian academic system), or postponed (i.e., not taken in the regularly scheduled period).\n* Experience significant distress as assessed by the Kessler psychological distress scale (K-10) ≥ 16.\n\nExclusion Criteria:\n\n• None",{"count":670,"type":22},210,[25],"Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.",[28,674,257,222],"Psychological Well-Being",[676,677,678,679],"prevention","university students","academic deceit","emotion regulation","2026-03-11",{"date":682,"type":38},"2026-03-13",{"date":684,"type":38},"2025-03-10",{"date":635,"type":22},{"name":687,"class":45},"University of Padova",3,{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":696,"enrollmentInfo":697,"targetDuration":4,"studyType":23,"phases":698,"briefSummary":699,"conditions":700,"keywords":704,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":46},"100627319","emdr-integrative-group-protocol-and-individual-treatment-for-patients-with-cancer-a-pilot-study-100627319","NCT07447089","EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study","Combination of the EMDR Integrative Group Protocol and Individual EMDR Treatment in Patients With Advanced Thyroid Cancer: A Pilot Study","Inclusion Criteria:\n\n* cancer diagnosis\n* PTSD (IES-R \\> 32)\n\nExclusion Criteria:\n\n* receiving specialized trauma therapy\n* receiving current psychiatric pharmacological treatment, unless the dosage has been stable for at least 2 months prior to enrollment","100 Years",{"count":7,"type":22},[25],"The main aim of the present process-outcome study is to evaluate the feasibility and the effects of an EMDR-IGTP-OTS group intervention on a sample of people with cancer, by using a process-outcome study design, with repeated measures.",[701,702,703,28],"Thyroid Neoplasms","Neoplasm","Post-traumatic Stress Disorder (PTSD)",[705,594],"Psychoncology","2026-03-02",{"date":708,"type":38},"2026-03-04",{"date":710,"type":38},"2025-12-05",{"date":712,"type":22},"2026-12-05",{"name":714,"class":45},"Università Cattolica di Milano",{"id":716,"slug":717,"hasResults":12,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":721,"eligibilityCriteria":722,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":723,"targetDuration":4,"studyType":23,"phases":725,"briefSummary":726,"conditions":727,"keywords":728,"overallStatus":106,"whyStopped":4,"lastUpdateSubmitDate":731,"lastUpdatePostDateStruct":732,"startDateStruct":734,"completionDateStruct":736,"leadSponsor":738,"locationsCount":46},"100625559","hypnotic-communication-in-cardiology-a-randomized-controlled-trial-100625559","NCT07424209","Hypnotic Communication in Cardiology: A Randomized Controlled Trial","The Effectiveness of Hypnotic Communication in Reducing Emotional Distress and Improving Patient Experience During Elective Coronary Angiography: A Monocentric Randomized Controlled Trial","IPNOCARDIO","Inclusion Criteria:\n\n* Adult patients (≥18 years), of both sexes, referred to the Cardiology Unit and scheduled for elective coronary angiography;\n* Ability to read and understand the Italian language.\n\nExclusion Criteria:\n\n* Cognitive impairment or neurodegenerative disorders that may compromise the ability to provide informed consent;\n* Psychiatric disorders, neurodegenerative diseases, or major depressive states.",{"count":724,"type":22},306,[25],"Undergoing medical procedures, especially surgical ones, is a significant source of emotional stress for patients. Emotions like anxiety, fear, anger, and depression often accompany such experiences and can negatively impact clinical outcomes. Preoperative anxiety, in particular, affects nearly half of all surgical patients and can lead to complications such as hemodynamic instability, increased medication needs, and prolonged recovery times.\n\nManaging this emotional distress is therefore a priority. While pharmacological strategies are commonly used, growing attention is being given to non-drug interventions such as music, art, and play therapies. One such technique is hypnotic communication-a method that uses empathetic, suggestion-based language to influence emotional and physical states without formal hypnotic induction. This technique has roots in anesthesiology and has shown promise in reducing pain and anxiety during medical procedures.\n\nThe proposed study aims to evaluate the effectiveness of hypnotic communication in reducing emotional distress in patients undergoing elective coronary angiography. This will be done through a randomized controlled trial involving 306 adult patients at the Cardiology Unit of the Ospedale degli Infermi in Biella, Italy.\n\nParticipants will be randomly assigned to either an experimental group receiving hypnotic communication alongside standard care, or a control group receiving standard care only. The hypnotic session, delivered by trained nurses, will begin before the procedure and continue until it ends, following a five-phase structure (pre-induction, induction, core, de-induction, and closure).\n\nThe primary outcome is the patient's emotional state-specifically stress, anxiety, depression, anger, and need for help-measured before and after the procedure using the Emotion Thermometer Tool. Secondary outcomes include post-procedural pain (measured 15 and 60 minutes after) and patient satisfaction with the communication technique.\n\nThe study is designed with a type I error rate of 0.05 and 80% statistical power, and recruitment is expected to last 24 months. Data will be anonymized, securely stored, and analyzed using appropriate statistical methods. Ethical approval and informed consent are integral parts of the protocol.\n\nBy investigating the emotional and clinical impact of hypnotic communication, the study hopes to support its integration into routine care practices, offering a simple, safe, and cost-effective method to enhance patient well-being during invasive procedures.",[28,437,222],[729,31,730,437,222],"Hypnosis","Coronary Angiography","2026-02-13",{"date":733,"type":38},"2026-02-20",{"date":735,"type":38},"2025-06-09",{"date":737,"type":22},"2027-10-09",{"name":739,"class":45},"Università degli Studi del Piemonte Orientale Amedeo Avogadro"]