Written Exposure Therapy for Post-traumatic Stress Syndrome

Sponsor
Karolinska Institutet (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04328935
Collaborator
(none)
12
1
1
18
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WET
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Within-group design. Repeated measurementsWithin-group design. Repeated measurements
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
Actual Study Start Date :
Oct 27, 2020
Actual Primary Completion Date :
Apr 27, 2021
Anticipated Study Completion Date :
Apr 27, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska Institutet Stockholm Sweden

Sponsors and Collaborators

  • Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erik Andersson, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT04328935
Other Study ID Numbers:
  • 2019-04414
First Posted:
Apr 1, 2020
Last Update Posted:
Jun 1, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erik Andersson, Principal investigator, Karolinska Institutet
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2021