- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035562
Promoting Positive Emotional Functioning in Police and Military Populations
May 29, 2025 updated by: Kevin Barber, University of Manitoba
This study will examine whether actively serving and veteran members of the Canadian Armed Forces (CAF) and Royal Canadian Mounted Police (RCMP) who complete a treatment targeting anhedonia symptoms and amplifying positive emotional processing: 1) experience significant symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased experience of positive emotions; 3) report improvements to broad functioning and quality of life; and 4) find the treatment to be highly tolerable.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
65
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Manitoba
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Winnipeg, Manitoba, Canada, R3J 0L3
- Deer Lodge Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Be an actively serving or veteran member of the CAF and RCMP;
- Have been referred to receive the treatment protocol at the OSIC at Deer Lodge Centre by a doctor or psychologist;
- Have previously participated in at least one evidence-based psychological treatment for depressive, anxiety, or trauma-and-stressor-related condition at OSIC but remain clinically symptomatic;
- Be able to speak, read, and write in English;
- Have no current psychosis, untreated bipolar disorder, or current suicidal ideation with plan and intent;
- Be on a stable medication regime and agree to not make changes for the duration of the treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PVSET
Participants will receive a course of individual therapy through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre.
Therapy will consist of a validated treatment protocol known as Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.
Therapy sessions will be facilitated by psychologists, licensed therapists (e.g., MSW, RPN), and/or graduate students in psychology under supervision at the OSIC.
PVSET will consist of 6 sessions, each lasting one hour, and will be delivered either virtually or in-person at OSIC depending on patient preference.
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6, one-hour sessions of individual therapy, consisting of Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depression symptoms
Time Frame: 6 weeks
|
Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9).
Scores on this scale range from 0-27, with higher scores indication more severe depression.
|
6 weeks
|
|
Change in anxiety symptoms
Time Frame: 6 weeks
|
Change in anxiety symptoms based on the Overall Anxiety Severity and Impairment Scale (OASIS).
Scores on this scale range from 0-20, with higher scores indication more severe anxiety.
|
6 weeks
|
|
Change in PTSD symptoms
Time Frame: 6 weeks
|
Change in PTSD symptom severity based on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).
Scores on this scale range from 0-80 with higher scores indicating greater symptom severity.
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in positive and negative affect
Time Frame: 6 weeks
|
Change in positive and negative affect based on the Positive and Negative Affect Schedule (PANAS).
Scores on the two subscales of this assessment range from 0-50, with higher scores on the positive affect subscale representing higher levels of positive affect, and lower scores on the negative affect subscale representing lower levels of negative affect.
|
6 weeks
|
|
Change in quality of life
Time Frame: 6 weeks
|
Change in quality of life as measure by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF).
Scores on this scale range from 0-70, and are converted to a percentage, with higher scores indicating greater life enjoyment and satisfaction.
|
6 weeks
|
|
Psychotherapy progress
Time Frame: 6 weeks
|
Psychotherapy progress as measured by the Outcome Questionnaire 45 (OQ-45).
A total score of all subscales ranges from 0 to 180, with higher scores indicating more severe distress and functional impairment.
|
6 weeks
|
|
Treatment acceptability
Time Frame: 6 weeks
|
Acceptability of the treatment program based on responses to a Treatment Acceptability Questionnaire.
Scores on this questionnaire range from 5-30 with higher scores indicating greater acceptability.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2023
Primary Completion (Actual)
May 12, 2025
Study Completion (Estimated)
August 1, 2025
Study Registration Dates
First Submitted
September 6, 2023
First Submitted That Met QC Criteria
September 6, 2023
First Posted (Actual)
September 13, 2023
Study Record Updates
Last Update Posted (Actual)
June 4, 2025
Last Update Submitted That Met QC Criteria
May 29, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS26055 (H2023:201)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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