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Group Written Exposure Therapy for Posttraumatic Stress Disorder (GWET)

Primary Purpose

Posttraumatic Stress Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group Written Exposure Therapy
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring cognitive behavioural therapy, written exposure therapy, group therapy, posttraumatic stress disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Between the ages of 18 and 65 years, inclusive Diagnosis of PTSD Able to provide written informed consent and can read and write in English Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group Written Exposure Therapy

    Arm Description

    Patients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)
    36-item self-report measure assessing emotion regulation difficulties.
    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.
    Group Cohesion Scale-Revised (GCS-R)
    Self-report measure assessing group member's perception of their group and the strength of the bonds formed.

    Full Information

    First Posted
    January 27, 2023
    Last Updated
    February 6, 2023
    Sponsor
    St. Joseph's Healthcare Hamilton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05729789
    Brief Title
    Group Written Exposure Therapy for Posttraumatic Stress Disorder
    Acronym
    GWET
    Official Title
    Investigating Group Written Exposure Therapy for Posttraumatic Stress Disorder: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 9, 2023 (Anticipated)
    Primary Completion Date
    May 9, 2025 (Anticipated)
    Study Completion Date
    May 9, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Joseph's Healthcare Hamilton

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posttraumatic Stress Disorder
    Keywords
    cognitive behavioural therapy, written exposure therapy, group therapy, posttraumatic stress disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    63 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group Written Exposure Therapy
    Arm Type
    Experimental
    Arm Description
    Patients will be invited to participate in group Written Exposure Therapy (described in the "Interventions" section).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group Written Exposure Therapy
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change from baseline on the PTSD Checklist for DSM-5 (PCL-5)
    Description
    20-item self-report questionnaire assessing symptoms of PTSD over the past week.
    Time Frame
    Weekly at each group session, 1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
    Secondary Outcome Measure Information:
    Title
    Change from baseline on the Posttraumatic Cognitions Inventory (PTCI)
    Description
    36-item self-report questionnaire assessing negative beliefs across three subscales: negative cognitions about the self, negative cognitions about the world, and self-blame.
    Time Frame
    1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
    Title
    Change from baseline on the Depression, Anxiety, Stress Scale -21 Item Version (DASS-21)
    Description
    21-item self-report measure with three subscales measuring depression, anxiety, and stress symptoms.
    Time Frame
    1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
    Title
    Change from baseline on the Difficulties in Emotion Regulation Scale (DERS)
    Description
    36-item self-report measure assessing emotion regulation difficulties.
    Time Frame
    1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
    Title
    Change from baseline on the Illness Intrusiveness Rating Scale (IIRS)
    Description
    13-item self-report measure assessing the effect of illness on domains of quality of life.
    Time Frame
    1 week before treatment begins, 1 week after treatment ends, and 1-month follow-up.
    Title
    Group Cohesion Scale-Revised (GCS-R)
    Description
    Self-report measure assessing group member's perception of their group and the strength of the bonds formed.
    Time Frame
    1 week after treatment ends.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Between the ages of 18 and 65 years, inclusive Diagnosis of PTSD Able to provide written informed consent and can read and write in English Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jenna Boyd, Ph.D.
    Phone
    905-522-1155
    Ext
    32749
    Email
    boydj@stjosham.on.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jenna Boyd, Ph.D.
    Organizational Affiliation
    St. Joseph's Healthcare Hamilton
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    35015065
    Citation
    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.
    Results Reference
    background
    Citation
    Sloan, D.M., & Marx, B.P. (2019). Written exposure therapy for PTSD: A brief treatment approach for mental health professionals. American Psychological Association.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    20488277
    Citation
    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.
    Results Reference
    background
    Citation
    Treadwell, 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.
    Results Reference
    background

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    Group Written Exposure Therapy for Posttraumatic Stress Disorder

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