Affect Management Group for Adult Survivors of Childhood Trauma
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| First Received Date ICMJE | September 29, 2006 | ||||||||
| Last Updated Date | June 2, 2009 | ||||||||
| Start Date ICMJE | May 2006 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Score on affect regulation capacity at week 14(post-interventional) and month 3 (follow-up) [ Time Frame: 2008 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Score on affect regulation capacity at week 8 (post-interventional) and month 6 (follow-up) | ||||||||
| Change History | Complete list of historical versions of study NCT00383006 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Affect Management Group for Adult Survivors of Childhood Trauma | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| Brief Summary | Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. The hypothesis is that the group therapy significantly improves the participant's capacity in emotion management and self-soothing. |
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| Detailed Description | Problems of self regulation, e.g. emotional dysfunction, represent a core symptom of adult patients with traumatic childhood experiences. Since sufficient capacity for self soothing and emotional regulation are essential for trauma exposure, modern trauma therapy concepts are phase-oriented, beginning with working on "stabilization". The study intends to evaluate the efficiency of a 14-week group therapy for adult survivors of relational trauma in childhood. Main interventions are psychoeducation about the sequelae of childhood trauma, teaching of skills for affect regulation and techniques for activating resources. Inclusion criteria are clinical significant problems with self-regulation and the presence of childhood trauma. Outcome measures are based on self-rating questionnaires, clinical interviews and an experimental computer-task at timepoint pre-, post- and 3-month-follow-up. There is no control condition in the pilot-study phase. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Stress Disorders, Post-Traumatic | ||||||||
| Intervention ICMJE | Behavioral: Skills for affect regulation (behavior) | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Withdrawn | ||||||||
| Estimated Enrollment ICMJE | 16 | ||||||||
| Estimated Completion Date | May 2008 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00383006 | ||||||||
| Other Study ID Numbers ICMJE | PSYUNIZH26092006 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | University of Zurich | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Zurich | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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