Promoting Positive Emotional Functioning in Police and Military Populations

Sponsor
University of Manitoba (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06035562
Collaborator
(none)
65
1
1
11.9
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: PVSET
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Promoting Positive Emotional Functioning in Police and Military Populations
Actual Study Start Date :
Sep 5, 2023
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Aug 31, 2024

Arms and Interventions

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.

Behavioral: PVSET
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.

Outcome Measures

Primary Outcome Measures

  1. Change in depression symptoms [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.

  2. Change in anxiety symptoms [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.

  3. Change in PTSD symptoms [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.

Secondary Outcome Measures

  1. Change in positive and negative affect [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.

  2. Change in quality of life [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.

  3. Psychotherapy progress [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.

  4. Treatment acceptability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Deer Lodge Centre Winnipeg Manitoba Canada R3J 0L3

Sponsors and Collaborators

  • University of Manitoba

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kevin Barber, Principal Investigator, University of Manitoba
ClinicalTrials.gov Identifier:
NCT06035562
Other Study ID Numbers:
  • HS26055 (H2023:201)
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023