Written Exposure Therapy for Post-traumatic Stress Syndrome
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Behavioral: WET
- Registration Number
- NCT04328935
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder
- Detailed Description
A non-inferiority trial in JAMA Psychiatry showed that written exposure therapy (WET) was non-inferior to a gold standard CBT treatment. In comparison to other trauma-focused CBT protocols, WET generally demands less therapist-time, and specifically, less than half compared to CBT that consists of 12 weekly sessions á 60 minutes. The aim of this study is to translate and replicate these results in a Swedish context. This first step is a small feasibility trial which will guide a subsequent large-scale trial.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 12
- Meet criteria for PTSD.
- If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry.
- ≥ 18 years
- Situated in Sweden
- Be able to express themselves in Swedish, both in verbally and written form.
- Informed consent
- Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI)
- Ongoing CBT for trauma
- Ongoing trauma-related threat (e.g. living with a violent spouse)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description written exposure therapy WET The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.
- Primary Outcome Measures
Name Time Method The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Time Frame: Baseline, week 5 and follow-up at 6 months Change in symptoms of post traumatic stress from baseline to post treatment and follow up (6 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity
- Secondary Outcome Measures
Name Time Method Euroqol, EQ-5D Time Frame: Baseline, week 5 and follow-up at 6 months Change in overall health from baseline to post treatment and follow up (6 months). EQ-5D is a standardised self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in "work, study, housework, family or leisure activities". In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity.
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) Time Frame: Baseline, week 5 and follow-up at 6 months Change in depressive symptoms from baseline to post treatment and follow up (6 months). The Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) is a 9 item self-report measure that assesses the presence and severity of depressive symptoms. All items are scored on a 0-6 scale. Higher score indicate worse severity.
Trial Locations
- Locations (1)
Karolinska Institutet
🇸🇪Stockholm, Sweden