[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complex-post-traumatic-stress-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complex-post-traumatic-stress-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,75,101,138],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100594140","treatment-of-complex-post-traumatic-stress-disorder-among-displaced-people-in-switzerland-and-germany-100594140",false,"NCT07015567","Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland and Germany","Contextualised, Culture-sensitive Diagnosis and Psychotherapy for the Treatment of Complex Post-traumatic Stress Disorder Among Displaced People in Switzerland and Germany: A Two-step Multicentric Randomised Clinical Trial","ESTAIR_REFUGEE","Inclusion Criteria:\n\n* Informed consent signature\n* Refugees and asylum seekers with a valid residence permit (N, F, B, or C status)\n* Speaking Arabic, Farsi\u002FDari, Pashtu, Kurdish (different dialects), or Turkish\n* A psychotherapy is indicated and was prescribed\n* Participated to part 1 of the study and was diagnosed with CPTSD on the basis of the standard International Trauma Interview and the Socio-cultural and structural addendum (SCSA). The diagnosis is done based on the clinical judgement by the local therapist.\n\nExclusion Criteria:\n\n* Acute psychosis\n* Imminent risk of suicide\n* Severe alcohol and\u002For substance abuse\n* Being enrolled in another psychotherapy\n* Inability to follow study procedures (i.e., cognitive impairment)\n* Inability to give informed consent\n* Known pregnancy","ALL","17 Years",{"count":20,"type":21},288,"ESTIMATED","INTERVENTIONAL",[24],"NA","In WHO ICD-11 (its latest edition), the diagnostic criteria for post-traumatic stress disorder (PTSD) were revised, and a new sibling disorder, complex post-traumatic stress disorder (CPTSD) was introduced. CPTSD is a debilitating condition associated with severe, prolonged, or chronic trauma. Refugee populations are affected by high prevalence of CPTSD because of high rates of such trauma (e.g. torture). Untreated CPTSD has negative consequences for quality of life and for integration into the host society. Evidence indicates cultural variation in the phenomenology of CPTSD.\n\nModular approaches, e.g., the Skills Training in Affective and Interpersonal Regulation combined with Modified Prolonged Exposure (ESTAIR\u002FMPE), have been recommended for the treatment of CPTSD. However, they have not been tested in a clinical trial among refugees so far and there are no available publications about their effectiveness in CPTSD symptom reduction among this population. Research suggests a higher symptom reduction of trauma-focused techniques, such as Narrative Exposure Therapy (NET), among refugee population. In a previous study, the investigators pilot tested a version of ESTAIR\u002FNET that was adapted to sociocultural and structural aspects related to psychopathology in refugee populations. The performance of these culturally adapted modules in CPTSD symptom reduction among the refugee population remains to be assessed.\n\nThe present clinical trial seeks to assess the effect of the culturally adapted modules of the ESTAIR manual on symptom reduction among refugees and asylum seekers diagnosed with CPTSD.",[27],"Complex Post-Traumatic Stress Disorder",[29,30,31,32],"Refugee populations","Cultural adaptation","Factorial experiment","Culturally sensitive psychotherapy","RECRUITING","2026-05-11",{"date":36,"type":37},"2026-05-12","ACTUAL",{"date":39,"type":37},"2026-01-21",{"date":41,"type":21},"2030-12",{"name":43,"class":44},"Eva Heim","OTHER",7,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100555806","a-pilot-study-of-trauma-focused-cognitive-behavioral-therapy-for-treatment-of-post-traumatic-stress-in-adults-100555806","NCT06516874","A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.","A Pilot Study of Feasibility and Acceptability of Videoconference-Delivered Trauma-Focused Cognitive Behavioral Therapy for Treatment of PTSD and C-PTSD in Adults of Community and Hospitals Mental Health Services","Eligibility criteria:\n\n* Men and women over 18 years of age.\n* Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or the complex form of Post-Traumatic Stress Disorder (CPTSD).\n* Not being treated for PTSD or C-PTSD at the time of recruitment\n\nInclusion Criteria:\n\n* Men and women over 18 years of age.\n* Referred to a community mental health care service (CMHCS) or hospital in the Maule Region for difficulties associated with the experience of traumatic events, symptomatology, or diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD).\n* Having the diagnosis of Post-Traumatic Stress Disorder (PTSD) or Complex Post-Traumatic Stress Disorder (CPTSD) by International Trauma Interview (ITI).\n* Fluent in oral and written Spanish language.\n* Access to telephone.\n\nExclusion Criteria:\n\n* Previously or currently diagnosed psychotic disorder.\n* Current substance use disorder.\n* Current suicidal crisis.\n* Depression is the primary diagnosis.\n* Participation in a PTSD psychological treatment parallel to the study.\n\nStudy's exit criteria:\n\n* Initiation of a psychological or pharmacological treatment for PTSD parallel to the study.\n* Change of medication dose in the case of participants with pharmacological treatment prior to the study.","18 Years","64 Years",{"count":56,"type":21},13,[24],"Post-traumatic stress disorder (PTSD) is a mental health condition that's triggered by the experience of potentially traumatic events. Complex PTSD (CPTSD) includes additional symptoms that account for a disturbance of the organization of the self. Randomized controlled trials have shown that trauma-focused cognitive behavioral therapy (TF-CBT) is effective in reducing PTSD symptoms; however, there is insufficient evidence to support the effectiveness of this intervention for CPTSD.\n\nThe present study aims to evaluate the feasibility and acceptability of TF-CBT therapy for complex presentation (TF-CBT-CP) in a videoconference modality in adults diagnosed with PTSD or CPTSD who are treated at community mental health care services (CMHCS, COSAM in Spanish) and the Hospital of the Maule Region, Chile.\n\nThis pilot study will use a mixed design. The quantitative component will consist of a one-group pre-post-follow-up design, which will include 13 adults diagnosed with PTSD or CPTSD referred to care at CMHCS or hospitals of the Maule Region, Chile. Telephone interviews will collect qualitative data relevant to the study's acceptability.\n\nParticipants will receive TF-CBT-CP therapy. It consists of 16 weekly 60-minute sessions of trauma-focused cognitive behavioral therapy for complex presentations.\n\nTo determine the feasibility of TF-CBT-CP therapy, eligibility, recruitment, participation, activity completion, retention, exit, and dropout rates will be considered. To establish the acceptability of the protocol, participant satisfaction with the recruitment, assessment, and treatment process and reporting of reasons for non-participation or dropout will be assessed. Furthermore, secondary outcomes consider the reduction of PTSD and CPTSD symptomatology, depression, and anxiety and the improvement of indicators of emotional regulation and psychological well-being.",[60,27],"Post Traumatic Stress Disorder",[62,63,64,65],"Pilot Study","Feasibility","Acceptability","Trauma-Focused Cognitive Behavioral Therapy","2026-01-30",{"date":68,"type":37},"2026-02-03",{"date":70,"type":37},"2024-10-22",{"date":72,"type":21},"2027-03-31",{"name":74,"class":44},"University of Talca",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":98,"locationsCount":100},"100569215","effectiveness-of-trauma-treatment-in-the-specialist-health-care-services-100569215","NCT06691347","Effectiveness of Trauma Treatment in the Specialist Health Care Services","Towards Evidence-based PTSD Care in Norwegian Specialist Health Services - A Randomized Controlled Trial","Inclusion Criteria:\n\n* age ≥18 years\n* meeting criteria for PTSD based on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a total score ≥23\n\nExclusion Criteria:\n\n* insufficient mastery of the Norwegian language\n* severe intellectual impairment (estimated IQ of 70 or less)\n* comorbid psychiatric illnesses in an acute phase where other types of treatment need to be prioritized (e.g. hospitalization)\n* history of EMDR or CT-PTSD treatment",{"count":83,"type":21},270,[24],"Post-traumatic stress disorder (PTSD) is a common mental illness. Treatments for PTSD are regarded as highly effective, but a large-scale, prospective, longitudinal randomized controlled trial comparing the effectiveness of these treatments has been requested by the research community. This study aims to conduct a comprehensive investigation into the effectiveness of two prominent PTSD therapies, eye movement desensitization and reprocessing (EMDR) and cognitive therapy for PTSD (CT-PTSD), within the Norwegian specialist health care services. The study aims to compare the therapy effectiveness, including their impact on comorbid disorders, complex PTSD symptoms, and functional outcomes post-treatment. Patients will be randomly assigned to EMDR or CT-PTSD and given manualized therapy aligned with their treatment goals. Each arm aims to recruit 135 patients, resulting in a total sample size of 270 patients.\n\nThe main objective of this study is to examine the growth curves of the two methods and how patient characteristics affect their developments. Secondary short-term aims include (1) investigating the impact of EMDR and CT-PTSD on complex PTSD symptoms, (2) assessing effects on other clinical conditions and functional outcomes, and (3) exploring whether the therapeutic alliance mediates treatment effects. Secondary long-term aims are (1) to assess the long-term effects of EMDR and CT-PTSD on PTSD symptoms and (2) to explore the impact of extended or additional treatments on outcomes.",[87,88,89,27,90,91],"Post Traumatic Stress Disorder PTSD","Quality of Life","Functional Outcome","Eye Movement Desensitization and Reprocessing","Cognitive Therapy","2024-11-13",{"date":94,"type":37},"2024-11-15",{"date":96,"type":37},"2024-09-26",{"date":41,"type":21},{"name":99,"class":44},"Vestre Viken Hospital Trust",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":118,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":100},"100558335","body-oriented-psychotherapy-for-individuals-with-a-history-of-child-maltreatment-and-trauma-related-symptoms-100558335","NCT06549777","Body-oriented Psychotherapy for Individuals With a History of Child Maltreatment and Trauma-related Symptoms","Body-oriented Psychotherapy vs. Psychoeducation and Treatment Information for Individuals With a History of Child Maltreatment and Trauma-related Symptoms: Assessing Safety, Feasibility, Acceptability, and Preliminary Outcomes","Inclusion Criteria:\n\n* Adults (18 years or older).\n* Proficiency in Swedish Language.\n* Access to a computer\u002Finternet.\n* Meeting CTQ-cutoff for CM history (CTQ rating higher than 'none \u002F minimal' in at least one of the subscales according to Bernstein and Fink (1998) (i.e. ≥10 for emotional neglect, ≥ 8 for physical neglect, ≥9 for emotional abuse, ≥8 for physical abuse and ≥6 for sexual abuse).\n* Meeting at least moderate\u002Fsevere PTSD or complex PTSD symptoms on the ITQ.\n* If taking medication, it must have been ongoing for at least 3 months and the dose must have been stable for 1 month.\n* Signed informed consent provided.\n\nExclusion Criteria:\n\n* Participants screen positive for alcohol (AUDIT) or substance abuse (DUDIT).\n* Psychotic symptoms, ongoing manic episode, acute suicidality.\n* If ongoing medication has an impact on the physiological data (ECG) recorded during the social paradigms, physiological data will be excluded from the analyses (but not exclusion for the treatment).\n* Have current (pre-assessment) ongoing psychological treatment focusing on social safeness, PTSD or complex PTSD.","100 Years",{"count":110,"type":21},50,[24],"This Pilot Randomized Controlled Trial (RCT) overall aim is to establish the safety, feasibility, acceptability and preliminary effects of a body-oriented psychotherapy, Somatic Experiencing (SE), on social functioning and mental health among adults with a history of Child Maltreatment (CM) and symptoms of posttraumatic stress disorder (PTSD) or complex posttraumatic stress disorder (CPTSD). Participants will be randomized either to an SE-group (n=25, psychoeducation, and information about treatment possibilities + 15-session SE treatment) or to a control group (n=25, same psychoeducation and information about treatment possibilities + regular phone calls to provide updates on their well-being and if they started a treatment). Given the lack of research on the effect of SE on Psychological Safety in this population, while SE has not yet been introduced into the Swedish health care system, special consideration will be given to participant safety, feasibility and acceptability of the SE-treatment. This includes monitoring (and assessing) for serious adverse events (SAEs) and adverse events (AEs), if conducting an RCT on SE in our target sample is feasible (e.g., achieving the target sample goal, assessing attrition rates and session attendance) and the acceptance of the used SE intervention (e.g., positive evaluations and willingness to recommend the treatment). Next to assessing safety, feasibility and acceptability, preliminary outcomes (self-report and experimental measures) will be evaluated at pre-treatment, post-treatment (20 weeks after pre), and at a 20-week follow-up, assessing primary outcomes (Psychological Safety) and secondary outcomes (Social Safeness, PTSD, CPTSD, Depression), as well as additional factors (e.g., interoception) that could contribute to decreased mental health and social functioning issues. Additionally, participants' behavioral (e.g., interpersonal distance) and physiological responses (HR, HRV, EDA) to social stimuli will be assessed pre- and post-treatment in an experimental setup to explore SE's potential to reduce Negative Affect and increase Positive Affect (Activated, Relaxed, Safe\u002FContent) in response to social stress.",[114,115,116,117,60,27],"Safety, Psychological","Acceptability of Health Care","Psychological Safety","Maltreatment, Child",[119,63,120,121,122,123,124,125,126,127,128],"Safety","Body-oriented intervention","Somatic Experiencing","Psychological safety","Social safeness","Childhood maltreatment","Post traumatic stress disorder","Complex Post traumatic stress disorder","Interoception","Depression","2024-10-11",{"date":131,"type":37},"2024-10-15",{"date":133,"type":37},"2024-09-06",{"date":135,"type":21},"2026-11",{"name":137,"class":44},"Monique Pfaltz",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":100},"100551772","complex-posttraumatic-stress-disorder-in-urban-egypt-pilot-testing-of-a-culturally-adapted-evidence-based-treatment-manual-and-development-of-a-culture-specific-diagnostic-100551772","NCT06464432","Complex-Posttraumatic Stress Disorder in Urban Egypt: Pilot Testing of a Culturally-adapted Evidence-Based Treatment Manual and Development of a Culture-specific Diagnostic","Inclusion Criteria:\n\n* Egyptian\n* 18 years of age or older\n* Literate, can give written or oral consent\n* History of severe and\u002For prolonged trauma, and screen positive for CPTSD\n* Reside in any other major city\n\nExclusion Criteria:\n\n* Imminent risk of suicide, psychotic symptoms, and\u002For severe alcohol and\u002For drug abuse\n* Have been in therapy before (i.e., completed more than 5-10 sessions of psychotherapy)",{"count":145,"type":21},20,[24],"Background: The CPTSD diagnosis presented in the ICD-11 is supposed to provide core and culturally invariant symptoms, which is supported by recent research. Yet, evidence also shows the necessity of integrating culture-specific symptoms in intervention and diagnostic tools to enhance the validity and efficacy of such diagnoses and therapeutic interventions. Along with cultural aspects, there are relevant structural aspects e.g., economic, and social inequalities, which impact mental health. These aspects remain understudied in low middle income countries like Egypt, where there are considerable rates of violence.\n\nAims: The project aims to i) culturally adapt and pilot test the therapeutic manual ESTAIR\u002FMPE in urban Egypt, and ii) to pilot test a cultural and structural module for the diagnostic assessment of CPTSD among the same target population. The objective is to assess the feasibility, acceptability, and initial impact on clinical outcomes of both the manual and diagnostic modules.\n\nMethods: In earlier phases, the project gathered qualitative data from key informants on the cultural and structural dimensions of CPTSD in urban Egypt. Using the collected data, investigators culturally adapted this intervention and developed a diagnostic cultural module. Subsequently, the investigators will pilot-test it in four groups of five participants each, 20 participants in total. The project intends to collect both quantitative and qualitative measures to explore determined outcomes and analyze them accordingly.",[27],"2024-06-17",{"date":151,"type":37},"2024-06-20",{"date":153,"type":21},"2024-08-01",{"date":155,"type":21},"2025-03-01",{"name":157,"class":44},"University of Lausanne"]