MedPath

Written Exposure Therapy for Post-traumatic Stress Syndrome

Not Applicable
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
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
Read More
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)
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
written exposure therapyWETThe treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
Euroqol, EQ-5DTime 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

© Copyright 2025. All Rights Reserved by MedPath