Trauma-focused psychodynamic therapy and STAIR Narrative Therapy of post-traumatic stress disorder related to childhood maltreatment: a multicenter randomized clinical trial examining psychological, biological and health economic outcomes
Early Phase 1
- Conditions
- F43.1Post-traumatic stress disorder
- Registration Number
- DRKS00021142
- Lead Sponsor
- Abt. Psychosomatik und Psychotherapie, Universität Gießen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 364
Inclusion Criteria
Persons of all sexes with PTSD related to CM by a caretaker or person in authority over them before the age of 18 years, age: 18 to 65 years; continuing stable medication been ongoing for at least 3 months prior to study entry is permitted.
Exclusion Criteria
psychotic disorders, risk of suicide, ongoing abuse, acute substance related disorder, borderline personality disorder, dissociative identity disorder, organic mental disorder, severe medical conditions, concurrent psychotherapy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CAPS-5 total score (post, 6 and 12 months after treatment termination)
- Secondary Outcome Measures
Name Time Method remission (CAPS-Total <20), response (50%-reduction of CAPS-total-score), complex PTSD (International Trauma Questionnaire), dissociative symptoms (Dissociative Experience Scale) depression (Beck Depression Inventory II), Clinical Global Impression rating for improvement (CGI-I), mentalization (Mentalization Questionnaire), attachment (Experiences in Close Relationships-Revised), personality organization (Borderline Personality Inventory), and number of treatment drop-outs<br><br>Assessements post, 6 and 12 months after treatment termination