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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04328935
Enrollment
12
Registered
2020-04-01
Start date
2020-10-27
Completion date
2022-04-27
Last updated
2021-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD, written exposure therapy

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.

Interventions

BEHAVIORALWET

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.

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Within-group design. Repeated measurements

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)Time Frame: Baseline, week 5 and follow-up at 6 monthsChange 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

MeasureTime frameDescription
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)Time Frame: Baseline, week 5 and follow-up at 6 monthsChange 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.
Euroqol, EQ-5DTime Frame: Baseline, week 5 and follow-up at 6 monthsChange 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026