NCT04328935

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2022

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

March 15, 2020

Last Update Submit

May 27, 2021

Conditions

Keywords

PTSDwritten exposure therapy

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

EXPERIMENTAL

The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.

Behavioral: WET

Interventions

WETBEHAVIORAL

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.

written exposure therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within-group design. Repeated measurements
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.

Locations