Post Traumatic Stress DisorderNCT04328935
Written Exposure Therapy for Post-traumatic Stress Syndrome
A study testing WET in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- WET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 27 Oct 2020to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
To investigate if written exposure therapy is feasible for patients with post-traumatic stress disorder
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- WET
- Keywords
- PTSD, written exposure therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WETBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| written exposure therapy | Experimental | The treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks. Receives: Behavioral: WET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: Baseline, week 5 and follow-up at 6 months
Secondary outcomes (2)
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.
Measured: Time Frame: Baseline, week 5 and follow-up at 6 months
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.
Measured: Time Frame: Baseline, week 5 and follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start27 Oct 2020
- Primary completion27 Apr 2021
- Study completion27 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within-group design. Repeated measurements
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Andersson, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328935
- Sponsor's protocol ID
- 2019-04414
- Other IDs
- 2019
- Status last verified
- May 2021
- First submitted
- 15 Mar 2020
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40891431
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study for Written Exposure Therapy for Patients With Post-traumatic Stress Disorder in a Regular Health Care Setting
- ClinicalTrials.gov ID
- NCT04328935
- Acronym / sponsor ID
- 2019-04414
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, written exposure therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 27 Apr 2021 (actual)
- Study completion
- 27 Apr 2022 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-group design. Repeated measurements
| Arm | Type | Receives |
|---|---|---|
| written exposure therapy | Experimental | Behavioral: WETThe treatment consists of written exposure therapy (WET), which is manualized trauma-focused CBT in five sessions over 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WETThe 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. | Behavioural | written exposure therapy |
Primary outcome
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 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
2 secondary outcomes
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
Time frame: Time Frame: Baseline, week 5 and follow-up at 6 months
Euroqol, EQ-5D
Time frame: Time Frame: Baseline, week 5 and follow-up at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Derived from this study: PubMed 40891431Hedvall 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WET in people with Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) (time frame: Time Frame: Baseline, week 5 and follow-up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04328935, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2021.