Posttraumatic Stress DisorderGWETNCT05729789
Group Written Exposure Therapy for Posttraumatic Stress Disorder
A study testing Group Written Exposure Therapy in people with Posttraumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD). The main questions it aims to answer are: Does group WET lead to a reduction in symptoms of PTSD? Is group WET better at reducing the number of patients… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Group Written Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2023to 9 May 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and older
- Diagnosis of PTSD
- Able to provide written informed consent and can read and write in English
Who cannot join
- Diagnosis of an active severe substance use disorder (SUD)
- Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, etc.)
- Untreated active psychotic, manic or hypomanic symptoms
- Has attempted suicide in the 2 months prior to beginning treatment
- Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment
- Has completed CPT in the past
- Has completed another active PTSD treatment, such as Prolonged Exposure or EMDR within the last year
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Anxiety Treatment and Research Clinic, St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8R2Y2
Jenna Boyd, PhD, 905-522-1155 ext. 32749, boydj@stjoes.ca
Jenna Boyd, PhD
About this study
Official title: Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study
The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD).
The main questions it aims to answer are:
Read more
- Does group WET lead to a reduction in symptoms of PTSD?
- Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)?
Participants will:
- Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker)
- Complete questionnaires relating to their symptoms at different points throughout the treatment
Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.
Read the detailed description
The primary objective of this study is to evaluate the effectiveness of group WET (G-WET) in reducing symptoms of PTSD in an outpatient hospital setting. In order to do so, we will evaluate outcomes of G-WET from pre- to post-treatment and at one month follow-up. We will also compare outcomes of G-WET to published benchmarks of individual WET outcomes and to a representative cohort of individuals who participate in group CPT at our clinic. A secondary aim of the study is to evaluate attendance and drop-out rates for group WET. In order to achieve this, we will recruit a sample of 63 individuals between the ages of 18 and 65 to participate in a group WET 6-session protocol (1 orientation session and 5 WET sessions) from an outpatient anxiety and related disorders clinic waitlist for group CPT. Participants will complete measures assessing PTSD, related symptoms (e.g., depression, anxiety) and group cohesion at pre-treatment, post-treatment, and 1-month follow-up. Attendance and drop-out rates will also be recorded. We hypothesize that group WET will be associated with significant reductions in PTSD symptoms and related symptoms and low dropout rates (i.e., less than 10%). We also hypothesize that outcomes for group WET will be comparable to those for group CPT and published individual WET benchmarks.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Group Written Exposure Therapy
- Keywords
- cognitive behavioural therapy, written exposure therapy, group therapy, posttraumatic stress disorder
- 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.
Group Written Exposure TherapyBehavioural
Group Written Exposure Therapy (GWET) is a brief cognitive behavioural therapy for PTSD aimed at allowing patients to process their traumatic experiences in a safe environment. GWET will consist of 6 group sessions (1 orientation session and 5 weekly group sessions). Participants will be asked to complete weekly in-session written exposures where they will recount their traumatic experience. The written exposure will be followed by a guided discussion about the experience of writing the exposure. There is no homework assigned between sessions. However, group members will be asked to refrain from avoiding thinking about the trauma between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group Written Exposure Therapy | Experimental | Patients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section). Receives: Behavioral: Group Written Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)
20-item self-report questionnaire assessing symptoms of PTSD over the past week.
Measured: Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Secondary outcomes (5)
Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)
36-item self-report questionnaire assessing negative beliefs across three subscales: negative cognitions about the self, negative cognitions about the world, and self-blame.
Measured: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21)
21-item self-report measure with three subscales measuring depression, anxiety, and stress symptoms.
Measured: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)
36-item self-report measure assessing emotion regulation difficulties.
Measured: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Illness Intrusiveness Rating Scale (IIRS)
13-item self-report measure assessing the effect of illness on domains of quality of life.
Measured: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Group Cohesion Scale-Revised (GCS-R)
Self-report measure assessing group member's perception of their group and the strength of the bonds formed.
Measured: 1 week after treatment ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start9 May 2023
- Primary completion9 May 2025 (estimated)
- Study completion9 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna Boyd, St. Joseph's Healthcare Hamilton
- Investigators
- Jenna Boyd, Ph.D., Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729789
- Sponsor's protocol ID
- 15477
- Acronym
- GWET
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
PubMed 35015065Sloan, D.M., & Marx, B.P. (2019). Written exposure therapy for PTSD: A brief treatment approach for mental health professionals. American Psychological Association.
Weathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.
Antony, M.M., Bieling, P.J., Cox, B.J., Enns, M.W., & Swinson, R.P. (1998). Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychological Assessment, 10(2), 176-181.
Foa, E.B., Ehlers, A., Clark, D.M., Tolin, D.F., & Orsillo, S.M. (1999). The Posttraumatic Cognitions Inventory (PTCI): Development and validation. Psychological Assessment, 11(3), 303-314.
Devins GM. Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease. J Psychosom Res. 2010 Jun;68(6):591-602. doi: 10.1016/j.jpsychores.2009.05.006. Epub 2009 Jul 17.
PubMed 20488277Treadwell, T., Lavertue, N., Kumar, V. K., & Veeraraghavan, V. (2001). The Group Cohesion Scale-Revised: Reliability and validity. International Journal of Action Methods: Psychodrama, Skill Training, and Role Playing, 54(1), 3-12.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT05729789
- Acronym / sponsor ID
- GWET / 15477
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- cognitive behavioural therapy, written exposure therapy, group therapy, posttraumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 9 May 2025 (estimated)
- Study completion
- 9 May 2025 (estimated)
- First posted
- 15 Feb 2023 (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.
The goal of this clinical trial is to test if Written Exposure Therapy (WET) works well in a group setting in patients with post-traumatic stress disorder (PTSD).
The main questions it aims to answer are:
- Does group WET lead to a reduction in symptoms of PTSD?
- Is group WET better at reducing the number of patients that drop out of treatment in comparison to group Cognitive Processing Therapy (CPT)?
Participants will:
- Attend 6 weekly sessions of group WET that will be delivered online by two therapists (psychologist and social worker)
- Complete questionnaires relating to their symptoms at different points throughout the treatment
Researchers will evaluate change in PTSD symptoms over time for people who participate in group WET. They will also compare the results of group WET to the results of group CPT to see if group WET shows a similar reduction in symptoms of PTSD and fewer treatment drop-outs.
Detailed description
The primary objective of this study is to evaluate the effectiveness of group WET (G-WET) in reducing symptoms of PTSD in an outpatient hospital setting. In order to do so, we will evaluate outcomes of G-WET from pre- to post-treatment and at one month follow-up. We will also compare outcomes of G-WET to published benchmarks of individual WET outcomes and to a representative cohort of individuals who participate in group CPT at our clinic. A secondary aim of the study is to evaluate attendance and drop-out rates for group WET. In order to achieve this, we will recruit a sample of 63 individuals between the ages of 18 and 65 to participate in a group WET 6-session protocol (1 orientation session and 5 WET sessions) from an outpatient anxiety and related disorders clinic waitlist for group CPT. Participants will complete measures assessing PTSD, related symptoms (e.g., depression, anxiety) and group cohesion at pre-treatment, post-treatment, and 1-month follow-up. Attendance and drop-out rates will also be recorded. We hypothesize that group WET will be associated with significant reductions in PTSD symptoms and related symptoms and low dropout rates (i.e., less than 10%). We also hypothesize that outcomes for group WET will be comparable to those for group CPT and published individual WET benchmarks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Written Exposure Therapy | Experimental | Behavioral: Group Written Exposure TherapyPatients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and older
- Diagnosis of PTSD
- Able to provide written informed consent and can read and write in English
Key exclusion criteria (7 listed)
- Diagnosis of an active severe substance use disorder (SUD)
- Diagnosis of a psychotic disorder (schizophrenia, schizoaffective disorder, etc.)
- Untreated active psychotic, manic or hypomanic symptoms
- Has attempted suicide in the 2 months prior to beginning treatment
- Has engaged in high-risk self-harm (e.g., cutting, burning, asphyxiation) in the 2 months prior to beginning treatment
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 |
|---|---|---|
| Group Written Exposure TherapyGroup Written Exposure Therapy (GWET) is a brief cognitive behavioural therapy for PTSD aimed at allowing patients to process their traumatic experiences in a safe environment. GWET will consist of 6 group sessions (1 orientation session and 5 weekly group sessions). Participants will be asked to complete weekly in-session written exposures where they will recount their traumatic experience. The written exposure will be followed by a guided discussion about the experience of writing the exposure. There is no homework assigned between sessions. However, group members will be asked to refrain from avoiding thinking about the trauma between sessions. | Behavioural | Group Written Exposure Therapy |
Primary outcome
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
20-item self-report questionnaire assessing symptoms of PTSD over the past week.
5 secondary outcomes
Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)
Time frame: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21)
Time frame: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)
Time frame: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Change from baseline on the Illness Intrusiveness Rating Scale (IIRS)
Time frame: 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
Group Cohesion Scale-Revised (GCS-R)
Time frame: 1 week after treatment ends.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 35015065Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
- BackgroundSloan, D.M., & Marx, B.P. (2019). Written exposure therapy for PTSD: A brief treatment approach for mental health professionals. American Psychological Association.
- BackgroundWeathers, F.W., Litz, B.T., Keane, T.M., Palmieri, P.A., Marx, B.P., & Schnurr, P.P. (2013). The PTSD Checklist for DSM-5 (PCL-5). Scale available from the National Center for PTSD at www.ptsd.va.gov.
- BackgroundGratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the difficulties in emotion regulation scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54.
- BackgroundAntony, M.M., Bieling, P.J., Cox, B.J., Enns, M.W., & Swinson, R.P. (1998). Psychometric properties of the 42-item and 21-item versions of the Depression Anxiety Stress Scales in clinical groups and a community sample. Psychological Assessment, 10(2), 176-181.
- BackgroundFoa, E.B., Ehlers, A., Clark, D.M., Tolin, D.F., & Orsillo, S.M. (1999). The Posttraumatic Cognitions Inventory (PTCI): Development and validation. Psychological Assessment, 11(3), 303-314.
- Background: PubMed 20488277Devins GM. Using the illness intrusiveness ratings scale to understand health-related quality of life in chronic disease. J Psychosom Res. 2010 Jun;68(6):591-602. doi: 10.1016/j.jpsychores.2009.05.006. Epub 2009 Jul 17.
- BackgroundTreadwell, T., Lavertue, N., Kumar, V. K., & Veeraraghavan, V. (2001). The Group Cohesion Scale-Revised: Reliability and validity. International Journal of Action Methods: Psychodrama, Skill Training, and Role Playing, 54(1), 3-12.
- Individual participant dataSharing planned: No
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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.
Jenna Boyd, Ph.D. principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Written Exposure Therapy in people with Posttraumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 inclusion and 7 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 17 Apr 2024. 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 Canada. 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?
Contact Jenna Boyd, Ph.D. (905-522-1155 ext. 32749, boydj@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on the PTSD Checklist for DSM-5 (PCL-5) (time frame: Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.). 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 NCT05729789, which also lists 8 linked publications.
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 17 Apr 2024.