Written Exposure Therapy for Post-traumatic Stress Syndrome

A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting

To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder

Study Overview

• Status: Active, not recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: WET

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: written exposure therapy; The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.	Behavioral: WET; The manual is based on established CBT interventions in trauma such as exposure. In short, the treatment is that the participant should be able to approach their intrusive memories and by doing this repeatedly, the memory will give rise to less discomfort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	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	Time Frame: Baseline, week 5 and follow-up at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)	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.	Time Frame: Baseline, week 5 and follow-up at 6 months
Euroqol, EQ-5D	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.	Time Frame: Baseline, week 5 and follow-up at 6 months

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): April 27, 2021
• Study Completion (Anticipated): April 27, 2022

Study Registration Dates

• First Submitted: March 15, 2020
• First Submitted That Met QC Criteria: March 29, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: PTSD; written exposure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2019-04414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Case report form (CRF) data will be imputed to a data file. Analysis will be performed by members of the study-team and quality control and crosscheck will be performed by independent party.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No