Brief Imagery Rescripting vs. Usual Care and Treatment Advice in Refugees with Posttraumatic Stress Disorder – A Multi-Center Randomized Controlled Trial
- Conditions
- F43.1Post-traumatic stress disorder
- Registration Number
- DRKS00019876
- Lead Sponsor
- Abteilung Klinische Psychologie und Psychotherapie,Institut für Psychologie,Fachbereich Psychologie & Sportwissenschaften,Goethe-Universität Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 95
1. having entered Germany as a refugee, 2. primary diagnosis of PTSD, 3. ability to communicate with therapist with/without interpreter, 4. having health insurance that covers psychotherapy costs, 5. being able to stay in the location of the study center for at least another six months, 6. willingness and readiness for trauma-focused treatment
1. life-time psychosis or bipolar disorder as assessed with the Mini International Neuropsychiatric Interview for DSM-5 (MINI)
2. acute suicide risk or risk of harm of others
3. substance dependence as assessed with the MINI
4. start of new medication within one month prior to the study (medication used for longer periods can be continued; pausing or ending medication during the study is allowed)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnosis of (Complex) PTSD assessed via the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013) and the Complex PTSD Item Set additional to the CAPS (COPISAC; Lechner-Meichsner & Steil, in preparation). The CAPS is a structured clinical interview assessing a diagnosis of PTSD based on DSM-5 criteria, PTSD symptom severity, as well as the onset and duration of symptoms, subjective distress, and functional impairment. The CAPS has very good psychometric properties and is widely considered as the gold standard in assessing PTSD. COPISAC has been newly developed and psychometric properties are currently under investigation. Data will be collected by trained assessors at baseline, after treatment ends and at 12-month follow-up. Remission is defined as not meeting DSM-5 criteria for PTSD or ICD-11 criteria für CPTSD.
- Secondary Outcome Measures
Name Time Method 1. Severity of PTSD and Complex PTSD symptoms according to CAPS (Weathers et al., 2013) and COPISAC (Lechner-Meichsner & Steil, in preparation)<br>2. Symptoms of PTSD and Complex PTSD (International Trauma Questionnaire;ITQ; Cloitre et al., 2018)<br>3. Psychiatric symptoms (General Health Questionnaire; GHQ-28; Goldberg, 1978); <br>4. Health-related quality of life(Euroqol-5D; EQ-5D; EuroQol Group, 2019); <br>5. Dissociative symptoms (Adolescent Dissociative Experiences Scale; ADES; Martínez-Taboas et al., 2004), <br>6. Quality of sleep (Pittsburgh Sleep Quality Inventory; PSQI; Buysse, Reynolds, Monk, Berman, & Kupfer, 1989);<br>7. Costs (Client Socio-Demographic and Service Receipt Inventory; CSSRI; Roick et al., 2001); <br>8. Satisfaction with treatment (Client Satisfaction Questionnaire; CSQ-8; Hasler et al., 2004; Larsen, Attkisson, Hargreaves, & Nguyen, 1979)