Back to resultsPromoting Positive Emotional Functioning in Police and Military Populations
Primary Purpose
Anhedonia
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PVSET
Sponsored by
About this trial
This is an interventional treatment trial for Anhedonia
Eligibility Criteria
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.
Sites / Locations
- Deer Lodge Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PVSET
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in depression symptoms
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.
Change in anxiety symptoms
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.
Change in PTSD symptoms
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
Change in positive and negative affect
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.
Change in quality of life
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.
Psychotherapy progress
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.
Treatment acceptability
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.
Full Information
NCT ID
NCT06035562
First Posted
September 6, 2023
Last Updated
September 6, 2023
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT06035562
Brief Title
Promoting Positive Emotional Functioning in Police and Military Populations
Official Title
Promoting Positive Emotional Functioning in Police and Military Populations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 5, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anhedonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PVSET
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PVSET
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression symptoms
Description
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.
Time Frame
6 weeks
Title
Change in anxiety symptoms
Description
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.
Time Frame
6 weeks
Title
Change in PTSD symptoms
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in positive and negative affect
Description
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.
Time Frame
6 weeks
Title
Change in quality of life
Description
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.
Time Frame
6 weeks
Title
Psychotherapy progress
Description
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.
Time Frame
6 weeks
Title
Treatment acceptability
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 0L3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Promoting Positive Emotional Functioning in Police and Military Populations
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