[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"distress-psychological\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:distress-psychological":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,88,119,142],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100572369","pilot-study-of-mindset-moments-among-adolescent-and-young-adult-cancer-survivors-100572369",false,"NCT06732375","Pilot Study of Mindset Moments Among Adolescent and Young Adult Cancer Survivors","Inclusion Criteria:\n\n* 19-25 years of age\n* Prior AYA cancer diagnosis\n* Completed primary treatment for their cancer\n* Score of 3 or above on the Distress Thermometer at the time of recruitment\n\nExclusion Criteria:\n\n* Individuals without legal capacity to give consent\n* Individuals who are not fluent in reading, writing, and speaking English",true,"ALL","19 Years","25 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the feasibility and acceptability of the Mindset Moments™ (MM™) program in managing psychological distress and resiliency in adolescent and young adult cancer survivors.\n\nStudy participation will involve attending 8 weekly, one hour, live online group sessions and completing daily 5 minute activities such as guided imageries and CBT check in within the app. Participants will also be asked to complete an online survey at the time of enrollment and at 4 and 8 weeks.",[27,28,29,30],"Cancer","Youth Cancer","Young Adult Cancer","Distress, Psychological",[32,33,34,35],"young adult cancer survivor","distress","youth cancer survivor","resilience","RECRUITING","2026-05-05",{"date":39,"type":40},"2026-05-06","ACTUAL",{"date":42,"type":40},"2025-06-13",{"date":44,"type":21},"2027-03",{"name":46,"class":47},"Duke University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":48},"100636006","a-scalable-trans-diagnostic-intervention-targeting-adolescent-agency-supported-by-conversational-ai-agencia-100636006","NCT07560072","A Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI (AGENCIA)","A Randomized Controlled Trial Protocol of a Scalable Trans Diagnostic Intervention Targeting Adolescent Agency Supported by Conversational AI","AGENCIA","Inclusion Criteria:\n\n* Adolescents aged 12 to 18 years at enrollment.\n* Presence of emotional or behavioral difficulties causing functional interference (e.g., irritability, impulsivity, emotional dysregulation, conflicts at home or school, avoidance).\n* Difficulties compatible with neurodevelopmental profiles, regardless of formal diagnosis.\n* Ability to use digital materials through a personal device and basic reading skills in Spanish.\n* Availability to attend assessments and participate in the intervention and follow-up schedule.\n* Informed consent from caregivers and assent from the adolescent.\n\nExclusion Criteria:\n\n* Acute clinical risk at pre-screening or screening (e.g., imminent self-harm risk, severe agitation, aggression, disorganized behavior, or unsafe behaviors requiring immediate clinical care).\n* Score of \"Severe\" on any of the three HoNOSCA screening items (self-harm, substance-related problems, or bullying\u002Fsocial problems).\n* Uncompensated sensory, motor, or language barriers preventing valid completion of assessments or participation (e.g., severe visual or hearing impairment, significant receptive\u002Fexpressive language difficulties, motor limitations preventing device use).\n* Intellectual disability defined by screening tools: ABAS-II GAC ≤ 70 or Kaufman Brief Intelligence Test Composite Intelligence Quotient ≤ 70.\n* Any condition judged by the clinical team to require immediate alternative care or that would prevent safe participation.","12 Years","18 Years",{"count":60,"type":21},465,[24],"The aim of this clinical trial is to evaluate whether AGENCIA, a brief psychological program supported by digital technology and artificial intelligence, can help reduce emotional and behavioral difficulties in adolescents aged 12 to 18. These difficulties may include irritability, impulsive behaviors, conflicts at home or at school, or difficulties in managing intense emotions. The study also aims to determine whether the effects are similar across adolescents with different symptom profiles or neurodevelopmental characteristics.\n\nParticipants will be randomly assigned to one of three groups:\n\nAGENCIA Digital: a self-guided online version completed at home. AGENCIA in-person with a digital assistant: a clinician-delivered version supported by an interactive digital assistant to guide the exercises.\n\nDigital psychoeducation (control): a self-guided online program providing general information about adolescent well-being.\n\nThe main research questions are:\n\nDoes AGENCIA reduce overall emotional and behavioral difficulties? Does the program improve functioning, family accommodation, and personal agency (a young person's sense of being able to act and make changes)? Are the effects similar across adolescents with different profiles or neurodevelopmental characteristics?\n\nParticipants will:\n\n* Complete three structured sessions depending on their assigned group.\n* Complete brief online questionnaires at baseline (T0), immediately after the sessions (T1), and at 1-month (T2) and 6-month (T3) follow-ups.\n* Receive brief phone calls during follow-ups to support questionnaire completion.\n\nA total of 465 adolescents will take part in the study. Participation is voluntary and does not replace usual clinical care. The study does not involve medication or invasive procedures, and all digital tools operate within secure institutional systems.",[64,65,66,67,68,30],"Irritability","Neurodevelopmental Disorders","Impulsivity","Emotional Dysregulation","Distress, Emotional",[70,71,72,73,74,75,76,77],"Adolescents","Randomized controlled trial","Personal Agency","Digital health intervention","Neurodevelopmental disorders","Family accommodation","Conversational AI","Trans diagnostic interventions","NOT_YET_RECRUITING","2026-04-23",{"date":81,"type":40},"2026-04-30",{"date":83,"type":21},"2026-04-01",{"date":85,"type":21},"2028-12-31",{"name":87,"class":47},"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla",{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":48},"100609034","who-psychological-interventions-for-mental-health-outcomes-in-migrants-resettled-in-italy-the-advance-trial-100609034","NCT07209306","WHO Psychological Interventions for Mental Health Outcomes in Migrants Resettled in Italy: the ADVANCE Trial","Testing the Effectiveness and Implementability of WHO Psychological Intervention Strategies for Improving Mental Health Outcomes in Migrant Populations Resettled in Italy: the ADVANCE Randomized Controlled Trial","ADVANCE-IT","Inclusion Criteria:\n\n* 18 years or older\n* Living in Italy temporarily or permanently as a migrant, including asylum seekers, refugees, labor migrants;\n* Having elevated levels of psychological distress (K10 \\>15.9);\n* Sufficient mastery (written and spoken) of one of the languages the SH+\u002FDWM intervention is being delivered in (i.e., English and\u002For Italian);\n* Oral and written informed consent before entering the study.\n\nExclusion Criteria:\n\n* Planning to permanently move back to their home country before the last follow-up assessment (at six months after randomization);\n\n  * Having acute medical conditions (requiring hospitalization);\n  * Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up based on screening tool and clinical judgement;\n  * Having a severe mental disorder (e.g., psychotic disorders, substance-dependence) based on clinical judgement;\n  * Having severe cognitive impairment based on clinical judgement (e.g., severe intellectual disability or dementia);\n  * Currently receiving specialized psychological treatment (e.g., Cognitive Behavioral treatment (CBT), Eye Movement Desensitizing and Reprocessing (EMDR));\n  * In case of current psychotropic medication use: being on an unstable dose for at least two months.",{"count":97,"type":21},237,[24],"Rationale: Migrant populations face numerous mental health risk factors, including unmet expectations, inadequate support, acculturation challenges, and legal hurdles. These stressors hinder their lives during and after migration. The World Health Organization has developed scalable psychological interventions, including Self Help Plus (SH+) and its online version Doing What Matters in Times of Stress (DWM), which are designed for delivery by non-professional helpers and adaptable to various cultures and mental health issues. While initial randomized controlled trials (RCTs) show these interventions are effective, their medium to long-term efficacy, implementability and scalability have not been thoroughly evaluated.\n\nObjectives: This study aims to examine the efficacy of SH+ and DWM versus a psychological placebo in reducing anxiety and depression symptoms among migrants experiencing elevated psychological distress. Additionally, it seeks to collect implementation outcomes to assess the feasibility and potential for scaling up these interventions.\n\nStudy design: We will conduct a hybrid three-arm efficacy-implementation randomized controlled trial.\n\nStudy population Adult asylum seekers, refugees or migrants with self-reported elevated psychological distress (K10 \\>15.9) (n=237).\n\nIntervention : All participants (in the three comparison groups) will receive Psychological First Aid (PFA) and enhanced care as usual (ECAU). In addition to PFA and ECAU, the intervention group 1 will receive SH+ complemented with an online booster session (delivered 4 weeks after SH+), the intervention group 2 will receive DWM complemented with an online booster session (delivered 4 weeks after DWM), and the intervention group 3 will receive psychological placebo (PsychP) complemented with an online session with neutral contents of the same duration of groups 1 and 2 (delivered 4 weeks after PsychP).\n\nMain study parameters\u002Fendpoints: Screening for inclusion and exclusion criteria will be interviewer-administered, in-person or through (video) calls. For all participants, online assessments will take place at baseline, at 4\u002F6 weeks after having received DWM (which corresponds to 1 week after the booster session, and 3 months after randomization), and at 6 months after randomization. The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to three-month after randomization, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). We expect to detect a Cohen's d effect size of 0.3 in the SH+ and DWM groups at 3 months after randomization. Additional health outcomes include level of anxiety (GAD-7) and depression (PHQ-9), functional impairment (WHODAS), wellbeing (WHO-5), quality of life (EQ-5D-5L), and cost of care (CSRI). Implementation outcomes will be measured with the Adoption of Information, Technology measure, Measure of Disseminability and Levels of Institutionalization tool, adverse events, and WHO fidelity forms. Additional study parameters include demographic data and dropouts.",[30,68],[102,103,104,105,106,107,108,109],"Migrant populations","Psychological distress","Psychological wellbeing","WHO psychological interventions","Effectiveness","Implementation","Self-Help Plus","Doing What Matters in Times of Stress","2025-10-02",{"date":112,"type":40},"2025-10-06",{"date":114,"type":40},"2025-04-09",{"date":116,"type":21},"2027-04-30",{"name":118,"class":47},"Universita di Verona",{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":126,"minAge":58,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":48},"100607935","womens-wellbeing-study-100607935","NCT07195019","Women's Wellbeing Study","Treatments for Improving Mood in Women","Inclusion Criteria:\n\n1. Female\n2. Ages 18-65\n3. Report having experienced interpersonal violence (defined to include all forms throughout the lifespan, confirmed with the Trauma History Questionnaire (THQ\\])\n4. Report being distressed, defined by a score of \\>5 on the Kessler-6 screener\n5. Speak and understand English well enough to understand questionnaires when they are read aloud\n6. Have access to a telephone through owning one, a relative\u002Ffriend, or an agency\n7. Have access to a device that will support use of the video platform we are using to conduct assessments and for home practice yoga video sessions\n\nExclusion Criteria:\n\n1. Inability to be physically active, determined by a score \\>1 on the Physical Activity Readiness Questionnaire (PAR-Q) and physician non-consent of participation\n2. Planned surgery in next 6 months, as this would interfere with study participation\n3. Pregnancy, as yoga should be modified for pregnancy\n\n   Women who meet criteria for the following:\n4. Current mania as determined by the Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)\n5. Lifetime history of psychotic disorders (DIAMOND)\n6. Current probable severe substance use disorder (DIAMOND)\n7. Current diagnosis of anorexia nervosa or history in past year (DIAMOND)\n8. Moderate or high risk for suicide on the adapted Columbia Suicide Severity Rating Scale screen version-recent (C-SSRS) and\u002For endorsement of suicidal plan\u002Fintent in the past 3 months\n9. Non-stable course of psychiatric treatments (medication, psychotherapy) for the last 8 weeks\n10. Plan to move from the area in the next 6 months, as this may preclude study participation given enrollment timeframes\n11. Self-report of experiencing intimate partner violence currently or within past six months (assessed by the Revised Conflict Tactics Scale 2 \\[R-CTS2\\]), as this would require a different type of intervention\n12. Current weekly yoga practice or current participation in mindfulness-based programming, as these are the study interventions","FEMALE","65 Years",{"count":129,"type":21},48,[24],"Phase 2 is a randomized controlled trial of integrative yoga and mindful self-compassion program vs. women's wellbeing education for women with a history of interpersonal violence exposure and heightened distress.",[30],"2025-09-19",{"date":135,"type":40},"2025-09-26",{"date":137,"type":40},"2025-08-27",{"date":139,"type":21},"2027-05-31",{"name":141,"class":47},"Butler Hospital",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":152,"phases":4,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":48},"100585897","psychotherapy-expectations-and-distress-among-mental-health-patients-and-their-therapists-100585897","NCT06908343","Psychotherapy Expectations and Distress Among Mental Health Patients and Their Therapists.","The Associations Between Psychotherapy Expectations and Distress Among Adults Hospitalized in Psychiatric Departments or Treated in the Ambulatory\u002FCommunity Clinics and Their Therapists.","Inclusion Criteria:\n\n* Hebrew mother tongue speakers\n* Being treated at Shalvata MHC.\n\nExclusion Criteria:\n\n* Inability to read or comprehend Hebrew due to any reason.\n* Agitative patients\n* Acute suicidal patients\n* Patients in unstable psychotic state",{"count":150,"type":21},100,"2 Months","OBSERVATIONAL","Patients will be recruited from the units of Shalvata MHC: closed and open hospitalization unit, and ambulatory units of Shalvata MHC community clinic. Their therapists will be recruited as well. There will be 4 timepoints measurement: baseline, second week, fourth week and after eight weeks (or discharge). Patients will be addressed through the therapeutic staff and the research team will contact them after a conceptually agreement to participate. A member of the research staff will schedule a meeting explaining the research thoroughly and ask the patient\u002Ftherapist to sign an informed consent. After signing an informed consent, patients will complete several questionnaires at several time points, whereas their therapists will complete measures as well. All scales will be filled using the Qualtrics platform. In hospitalization unit questionnaires will be filled with the aid of the research coordinator, and in the facilities of Shalvata MHC, in face-to-face interaction. During the face-to-face interaction, in case the patient will report suicidal thoughts or plan to a member of the research staff, the therapeutic staff will be notified immediately. patients at community clinics will fill the first measurement in face-to-face interaction and the rest of the questionnaires independently recieveg a link to their mobile phone.",[155,30],"Expectancy",[157,33,158,159],"process expectations","hospitalized patients","psychotherapy","2025-04-29",{"date":162,"type":40},"2025-05-02",{"date":164,"type":40},"2025-02-20",{"date":166,"type":21},"2025-12-31",{"name":168,"class":47},"Shalvata Mental Health Center"]