NCT06035562

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 5, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

September 6, 2023

Last Update Submit

May 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (4)

  • Change in positive and negative affect

    6 weeks

  • Change in quality of life

    6 weeks

  • Psychotherapy progress

    6 weeks

  • Treatment acceptability

    6 weeks

Study Arms (1)

PVSET

EXPERIMENTAL

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

Interventions

PVSETBEHAVIORAL

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.

PVSET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

Location

MeSH Terms

Conditions

Anhedonia

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

September 5, 2023

Primary Completion

May 12, 2025

Study Completion

August 1, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations