Clinical trial NCT05289882: Purpose After Service Through Sport (PASS)
Official title: Purpose After Service Through Sport (PASS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Well-Being (Psychological Flourishing)
Keywords: Mental Health
Physical Health
Military Veterans
Social Connectedness
Men's Health
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Using Optimal Design Software, and on the basis of 7 observations per participant (in psychological flourishing), 134 participants are required to detect a medium effect size of δ = .50, with Power (1 - β) set at 80%, and p \<.05 with seven time points (baseline, Months 1, 2, 3, 4, 5, and 6). To account for 9 sites across Canada (necessitating 8 dummy variables) requires an additional 80 participants. To further account for 10% attrition, a minimum of n= 238 veteran participants are needed. The study will look to recruit 252 military veterans for study participation. The study will also look to recruit N = 252 currently serving members of the Canadian Armed Forces, although it should be noted that these participants do not constitute the population of primary interest for the trial. On the basis of N = 252 military veterans and N = 252 currently serving military participants the trial will look to recruit a total of N = 504 participants.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of a gender-sensitized social-connectedness physical activity program in relation to key markers of well-being among military veteran men over 6 months.

Detailed description: The transition to civilian life can bring about substantive challenges for military veterans. Particular challenges include a loss of identity, feelings of loneliness and isolation, difficulties with finding and retaining employment, substance misuse, and problems adjusting to very different work and cultural environments. A growing body of scientific evidence also indicates that military veterans are at notable risk of depleted mental health (e.g., depression, suicide ideation).

The study involves broadening the evaluation (e.g., assess its impact on mental and physical health) and reach (e.g. extend to other Canadian cities) of a recently developed pilot program, Purpose After Service through Sport (PASS), which was completed in Vancouver in 2020 and assessed for its feasibility and acceptability. The results from this pilot study revealed that the program was well-received (by both military leadership and veterans themselves), fostered a sense of social connectivity among veterans, resulted in (self-reported) physical and psychological health benefits, and displayed considerable potential for scale up and evaluation using a randomized controlled trial (RCT) design.

The PASS Randomized Trial draws from the empirical evidence related to (a) the mental health benefits of regular physical activity, (b) benefits of group-based programs that foster social connectivity, (c) the importance of, and potential derived from, developing and implementing gender-sensitized programs, and (d) the pilot study described above.

Eligibility criteria: Inclusion Criteria:

* Former members of the Canadian (or Allied Forces; e.g., NATO countries) military, or current members of the Canadian military, and not experience any contraindication which might prevent that person from participating in moderate-intensity physical activity.
* Self-identification as a man (if sex at birth is 'female' but participants identify as 'man' they are eligible to participate).
* Have received full dosage of the COVID-19 vaccination (min 2 injections) and must provide proof of vaccination, as this is required to access all active military bases in Canada.
* Be able to read and understand English or French.
* Have access to a computer, tablet, or other device, that has access to the internet.
* Live at, or in close proximity to, one of the nine study locations (Esquimalt, BC; Edmonton, AB, Shilo, MB; Borden, ON; Kingston, ON; Petawawa, ON; Valcartier, QC; Montreal, QC; Gagetown, NB)

Exclusion Criteria:

* Not a former member of the Canadian (or Allied Forces; e.g., NATO countries) military, or current member of the Canadian military.
* Unable to participate in moderate-intensity physical activity (as screened via the PAR-Q and ePARmedX), including a lack of ability to receive doctor's clearance for participating in physical activity.
* Unable to speak or read English or French
* Lack of internet access which prevents access to online materials (e.g., questionnaires).
* Participants do not self-identify as 'man'. If participants disclose 'sex' as female but self-identify their gender identity as 'man' they are eligible to participate in the study and we would include their psychological responses in the main analyses. In such an instance, their biological measures (blood draws, blood pressure, and physical fitness tests) would be analyzed separately from those whose sex (male) and gender identity (man) are concordant.
* Not living in proximity to one of the participating sites (in order to take part in the in-person group-based activities).

Primary outcomes:
measure: Change in well-being (psychological flourishing) over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Secondary outcomes:
measure: Changes in life satisfaction over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in global physical and mental health over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in stress over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in anxiety over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in post-traumatic stress disorder symptomology over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in depression over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in resilience over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in social identification over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in social connectedness over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in loneliness over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in leisure-time physical activity over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Change in sleep quality over the course of the intervention
timeFrame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
measure: Program adherence over the course of the intervention
timeFrame: Weekly attendance at PASS program sessions over 6 month intervention
measure: Access and use of health services over the course of the intervention
timeFrame: Assessed over 6 months (descriptive measure)
Other outcomes:
measure: Physical fitness
timeFrame: Baseline (Month 0) and 6-month post PASS program commencement
measure: HbA1c
timeFrame: Baseline (Month 0) and 6-month post PASS program commencement
measure: Systolic and Diastolic Blood Pressure.
timeFrame: Baseline (Month 0) and 6-month post PASS program commencement
measure: C-reactive Protein (CRP)
timeFrame: Baseline (Month 0) and 6-month post PASS program commencement
measure: Telomere Length
timeFrame: Baseline (Month 0) and 6-month post PASS program commencement
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Mark R Beauchamp, PhD
role: PRINCIPAL_INVESTIGATOR
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