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
1 other identifier
interventional
12
1 country
1
Brief Summary
To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
October 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2022
CompletedJune 1, 2021
May 1, 2021
6 months
March 15, 2020
May 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Time Frame: Baseline, week 5 and follow-up at 6 months
Euroqol, EQ-5D
Time Frame: Baseline, week 5 and follow-up at 6 months
Study Arms (1)
written exposure therapy
EXPERIMENTALThe treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet
Stockholm, Sweden
Related Publications (1)
Hedvall H, Andersson E, Ivanov VZ, Bragesjo M. Feasibility of written exposure therapy for PTSD in a psychiatric outpatient clinic: in-person and remote delivery. Eur J Psychotraumatol. 2025 Dec;16(1):2545048. doi: 10.1080/20008066.2025.2545048. Epub 2025 Sep 2.
PMID: 40891431DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 15, 2020
First Posted
April 1, 2020
Study Start
October 27, 2020
Primary Completion
April 27, 2021
Study Completion
April 27, 2022
Last Updated
June 1, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
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.