Promoting Positive Emotional Functioning in Police and Military Populations

Anhedonia Clinical Trial

Official title:

Promoting Positive Emotional Functioning in Police and Military Populations

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06035562
• Other study ID #: HS26055 (H2023:201)
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 65
• Est. completion date: August 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anhedonia

Intervention

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.

Locations

Country	Name	City	State
Canada	Deer Lodge Centre	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Primary	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.	6 weeks
Primary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks
Secondary	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.	6 weeks