Back to resultsWritten Exposure Therapy for Post-traumatic Stress Syndrome
Primary Purpose
Post Traumatic Stress Disorder
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
WET
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, written exposure therapy
Eligibility Criteria
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)
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
written exposure therapy
Arm Description
The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04328935
Brief Title
Written Exposure Therapy for Post-traumatic Stress Syndrome
Official Title
A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
April 27, 2021 (Actual)
Study Completion Date
April 27, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
PTSD, written exposure therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Within-group design. Repeated measurements
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
written exposure therapy
Arm Type
Experimental
Arm Description
The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks.
Intervention Type
Behavioral
Intervention Name(s)
WET
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Description
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
Time Frame: Baseline, week 5 and follow-up at 6 months
Secondary Outcome Measure Information:
Title
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Description
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
Time Frame: Baseline, week 5 and follow-up at 6 months
Title
Euroqol, EQ-5D
Description
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
Time Frame: Baseline, week 5 and follow-up at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
Written Exposure Therapy for Post-traumatic Stress Syndrome
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