Written Exposure Therapy for Post-traumatic Stress Syndrome

Not Applicable

• Conditions: Post Traumatic Stress Disorder

• 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.

Study Timeline

• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-29
• Study First Posted: 2020-04-01
• Study Start: 2020-10-27
• Primary Completion: 2021-04-27
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-06-01
• Study Completion: 2022-04-27

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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