Clinical trial NCT05553249: Written Exposure Therapy for PTSD in a Virtual, Group-based Format
Official title: Written Exposure Therapy for PTSD: A Pilot Study of a Virtually Delivered Group-Based Intervention
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Actively serving and veteran members of the Canadian Armed Forces and RCMP, previously diagnosed by a psychologist or psychiatrist with PTSD or Other Specified Trauma and Stressor-Related Disorder (meeting PTSD Criterion A), who have been referred to the OSIC for psychological treatment of their trauma-related disorder.

Brief summary: The purpose of this study is to examine whether Written Exposure Therapy (WET) can be effectively delivered virtually and in a group format for the treatment of Post-Traumatic Stress Disorder in a military and police population. The objective of this study is to assess treatment feasibility and acceptability, drop out rates, changes in severity of trauma-related symptoms and symptoms of depression, quality of life, and the need for further trauma-focused treatment (TFT) for the the delivery of WET as a virtual, group based intervention.

Detailed description: This study will assess the efficacy and acceptability of WET being delivered virtually and in a group format for the treatment of PTSD through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre.

WET is offered in small groups of 10 patients. This study will follow 8 iterations of the group for a potential total of 80 participants in this study. Each WET group session will be facilitated by two OSIC clinicians, at least one of whom will be a clinical psychologist. Each session, administered via the Zoom app for healthcare, will start with a brief check in, then instructions will be provided to the whole group. Each group will receive a total of 5 therapy sessions, each of which will last approximately 1.5hrs.

Prior to the first WET session, participants will be asked to complete three clinical measures: Patient Health Questionnaire- 9 (PHQ-9), PTSD Checklist for DSM-5 (PCL-5, weekly version), and Outcome Questionnaire-45 (OQ-45). Participants will be asked to complete the PCL-5 prior to each session. Participants will also complete a Treatment Acceptability/Adherence Scale prior to the start of the second session.

Following the final session of therapy, participants will be asked to complete the three clinical assessment questionnaires (PHQ-9, PCL-5, and OQ-45) at 1 week, 1 month, and 3 months post-treatment. A research assistant will also follow-up with each participant at the 3-month mark to ask whether they have sought or attended further psychological treatment since the end of the WET sessions.

Eligibility criteria: Inclusion Criteria:

* Referred for Written Exposure Therapy at the Occupational Stress Injury Clinic (OSIC) in Winnipeg
* Able to speak, read, and write in English
* Medication held at a stable dose for four weeks prior to beginning treatment and throughout the duration of treatment (if on a prescribed medication)

Exclusion Criteria:

* Current psychosis
* Presence of another psychiatric disorder that requires prioritization over treating PTSD
* Any cognitive, visual, or motor impairment that would prevent writing for 30 minutes

Primary outcomes:
measure: Treatment acceptability
timeFrame: 5 weeks
Secondary outcomes:
measure: Attrition
timeFrame: 5 weeks
measure: Change in PTSD symptoms
timeFrame: 5 weeks
measure: Psychotherapy progress
timeFrame: 5 weeks
measure: Change in depression symptoms
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Carmen Bodkyn, PhD CPsych
role: PRINCIPAL_INVESTIGATOR
References: