Well-Being (Psychological Flourishing)NCT05289882
Purpose After Service Through Sport (PASS)
A study testing PASS Program Condition: in people with Well-Being (Psychological Flourishing), run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Well-Being (Psychological Flourishing)
- What is being tested?
- PASS Program Condition:
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Well-Being (Psychological Flourishing)
- Being tested
- PASS Program Condition:
- Keywords
- Mental Health, Physical Health, Military Veterans, Social Connectedness, Men's Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASS Program Condition:Behavioural
Participants randomized to this condition will be invited to take part in weekly ball hockey games (once per week), that will last approximately 60 minutes, and will be followed by opportunities to socially connect afterwards. The results of our feasibility study indicated that the PASS program acted as an important conduit to direct participants to other support services and resources (e.g., counseling, career transition centre, employment, education). Military veteran men are often reluctant to access such supports, especially if they attach stigma to such services (e.g., mental health services). At each site, a military veteran will be trained as a facilitator to operate as a conduit to refer participants to the relevant support services and agencies.
| Study group | Role | What they receive |
|---|---|---|
| PASS Program Condition | Experimental | Participants in this condition will take part in weekly physical activity, augmented with built-in opportunities to socially connect, and be directed to veteran-specific support services and resources. Receives: Behavioral: PASS Program Condition: |
| Waitlist Control | No intervention | Those randomized to the wait-list control condition will go about their daily lives for the duration of the 6-month assessment period (following randomization). They will be asked to complete the same measures (and will be remunerated in the same way as those in the PASS program condition, based on the completion of study measures). At the end of the 6-month trial, participants in this condition will have the opportunity to participate in the PASS program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in well-being (psychological flourishing) over the course of the intervention
Diener's (2010) flourishing scale will be used in the baseline survey, and will be in each monthly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Secondary outcomes (14)
Changes in life satisfaction over the course of the intervention
Life satisfaction will be assessed using the 1-item question by Fleeson (2004), with responses anchored from 0 to 10 where 0 means "the worst possible life overall" and 10 means "the best possible life overall".
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in global physical and mental health over the course of the intervention
Global indicators of physical and mental health will be assessed using items by Hays et al. (2009), each anchored on a 5-point scale (1 = "poor", 5 = "excellent") with higher scores reflecting better physical and mental health.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in stress over the course of the intervention
The 1-item Statistics Canada (2012) stress question will be used in the baseline survey and in monthly surveys to track changes in psychological stress over the study period. The SCSQ is a 1-item question, with responses anchored on a 5-point scale, with a possible scoring of 1 ("not at all stressful") to 5 ("extremely stressful"), with higher scores indicating more stress.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in anxiety over the course of the intervention
The 7-item generalized anxiety disorder scale (Spitzer et al., 2006) will be used to assess anxiety symptoms. Items are anchored on a 4-point scale (0 = "not at all" to 3 = "nearly every day") with higher scores indicative of more frequent experience of anxiety symptoms.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in post-traumatic stress disorder symptomology over the course of the intervention
The 20-item PTSD checklist for diagnostic and statistical manual of mental disorders-fifth edition (Bovin, 2016) will be used to assess PTSD symtomology. Items are anchored on a 5-point scale (1 = "not at all", 5 = "extremely") with higher scores reflective of higher levels of PTSD symptomology.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in depression over the course of the intervention
The 10-item center for epidemiologic studies depression scale by Andresen et al. (1994) will be used in the baseline survey, and will be in each monthly survey to track changes in depression symptoms over the study period. The possible range in scores is 0 to 30 depending on number of symptoms, with those symptoms weighted by frequency experienced in a week. Higher scores indicate more or more frequent symptoms.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in resilience over the course of the intervention
The brief resilience scale by Smith et al. (2008) will be used in the baseline survey, and will be in each monthly survey to track changes in resilience over the study period. This instrument uses a mean scoring system with a possible range in scores from 1-5; higher scores indicate the individual perceives they have a better ability to 'bounce back' and recover from stressful events and/or situations.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in social identification over the course of the intervention
The degree to which participants in the intervention condition identify with others in the program will be assessed using items adapted from the 4-item scale by Doosje et al. (1995). Note that this measure will only be administered to participants in the experimental (i.e., intervention) condition. Items are anchored on a 7-point scale (1 = "strongly disagree", 7 = "strongly agree") with higher scores reflecting greater social identification with the group.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in social connectedness over the course of the intervention
Social connectedness will be assessed using the 20-item social connectedness scale - revised (Lee et al., 2001). Items are anchored on a 6-point scale (1 = "strongly disagree", 6 = "strongly agree") with higher scores reflecting greater social connectedness with others.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in loneliness over the course of the intervention
Loneliness will be assessed using the 3-item loneliness scale (Hughes et al., 2004) in which items are anchored on a 3-point scale (1 = "hardly ever", 3 = "often") with higher scores reflecting greater loneliness.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in leisure-time physical activity over the course of the intervention
Leisure-time physical activity will be assessed using a modified version of the leisure score index (Courneya et al, 2004) that has been applied to Godin's leisure time exercise questionnaire (Godin \& Shepard, 1985). Participants report the frequency per week and time per exercise session of any mild, moderate, or strenuous exercise that participants complete.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in sleep quality over the course of the intervention
Sleep quality will be assessed using the 1-item measure developed by Buysse et al. (1989), that is anchored on a 4-point scale (1 = "very bad", 4 = "very good") with higher scores reflective of better sleep.
Measured: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Program adherence over the course of the intervention
Assessed using program logs maintained by location managers (intervention condition only).
Measured: Weekly attendance at PASS program sessions over 6 month intervention
Access and use of health services over the course of the intervention
Assessed, among intervention participants only, with a single question, "As a result of the PASS program, have you accessed support services for any of the following areas of need?", followed by an indication of which services were accessed, if any.
Measured: Assessed over 6 months (descriptive measure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: Unable to recruit sufficient sample to commence trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Well-Being (Psychological Flourishing)Studies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Beauchamp, University of British Columbia
- Investigators
- Mark R Beauchamp, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289882
- Sponsor's protocol ID
- H21-02693
- Status last verified
- May 2023
- First submitted
- 3 Mar 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The protocol for the study is available on the Open Science Framework (embargoed until 31/10/2022, to allow for study completion). The statistical analysis plan is also available on the Open Science Framework (embargoed until 31/10/2022). The consent form is freely available if requested from the Primary Investigator (Beauchamp, M).
Publications
Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
PubMed 8037935Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
PubMed 26653052Courneya KS, Jones LW, Rhodes RE, Blanchard CM. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport. 2004 Dec;75(4):429-33. doi: 10.1080/02701367.2004.10609176. No abstract available.
PubMed 15673042Dallaire RA, Wells DM. The transition to civilian life of veterans. 2014. www.senate-senat.ca/veac.asp
Diener E, Wirtz D, Biswas-Diener R, Tov W, Kim-Prieto C, Choi D-W, Oishi S. New measures of well-being: Short scales to assess flourishing and positive and negative feelings. Soc Indic Res. 2010;97, 143-156.
Doosje B, Ellemers N, Spears R. Perceived intragroup variability as a function of group status and identification. J Exp Soc Psychol. 1995;31(5), 410-436.
Feingold A. New Approaches for Estimation of Effect Sizes and their Confidence Intervals for Treatment Effects from Randomized Controlled Trials. Quant Method Psychol. 2019;15(2):96-111. doi: 10.20982/tqmp.15.2.p096.
PubMed 32775313Feingold A. Effect sizes for growth-modeling analysis for controlled clinical trials in the same metric as for classical analysis. Psychol Methods. 2009 Mar;14(1):43-53. doi: 10.1037/a0014699.
PubMed 19271847Feingold A. A Regression Framework for Effect Size Assessments in Longitudinal Modeling of Group Differences. Rev Gen Psychol. 2013 Mar;17(1):111-121. doi: 10.1037/a0030048.
PubMed 23956615Fleeson W. The quality of American life at the end of the century. In Brim OG, Ryff CD, Kessler RC (Eds.), How healthy are we?: A national study of well-being at midlife. 2004. University of Chicago Press.
Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
PubMed 4053261Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
PubMed 19543809Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
PubMed 18504506Kvam S, Kleppe CL, Nordhus IH, Hovland A. Exercise as a treatment for depression: A meta-analysis. J Affect Disord. 2016 Sep 15;202:67-86. doi: 10.1016/j.jad.2016.03.063. Epub 2016 May 20.
PubMed 27253219Lee RM, Draper M, Lee S. Social connectedness, dysfunctional interpersonal behaviors, and psychological distress: Testing a mediator model. J Couns Psychol. 2001; 48(3), 310-318.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purpose After Service Through Sport (PASS)
- ClinicalTrials.gov ID
- NCT05289882
- Acronym / sponsor ID
- H21-02693
- Conditions
- Well-Being (Psychological Flourishing)
- Keywords
- Mental Health, Physical Health, Military Veterans, Social Connectedness, Men's Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to recruit sufficient sample to commence trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PASS Program Condition | Experimental | Behavioral: PASS Program Condition:Participants in this condition will take part in weekly physical activity, augmented with built-in opportunities to socially connect, and be directed to veteran-specific support services and resources. |
| Waitlist Control | No intervention | –Those randomized to the wait-list control condition will go about their daily lives for the duration of the 6-month assessment period (following randomization). They will be asked to complete the same measures (and will be remunerated in the same way as those in the PASS program condition, based on the completion of study measures). At the end of the 6-month trial, participants in this condition will have the opportunity to participate in the PASS program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASS Program Condition:Participants randomized to this condition will be invited to take part in weekly ball hockey games (once per week), that will last approximately 60 minutes, and will be followed by opportunities to socially connect afterwards. The results of our feasibility study indicated that the PASS program acted as an important conduit to direct participants to other support services and resources (e.g., counseling, career transition centre, employment, education). Military veteran men are often reluctant to access such supports, especially if they attach stigma to such services (e.g., mental health services). At each site, a military veteran will be trained as a facilitator to operate as a conduit to refer participants to the relevant support services and agencies. | Behavioural | PASS Program Condition |
Primary outcome
Change in well-being (psychological flourishing) over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Diener's (2010) flourishing scale will be used in the baseline survey, and will be in each monthly survey to track changes in flourishing over the study period. There are 8 items, phrased in a positive direction. Scores can range from 8 (strong disagreement with all items) to 56 (strong agreement with all items), with higher scores indicating individuals who have a more positive view of themselves in important areas of functioning.
14 secondary outcomes
Changes in life satisfaction over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in global physical and mental health over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in stress over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in anxiety over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in post-traumatic stress disorder symptomology over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in depression over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in resilience over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in social identification over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in social connectedness over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in loneliness over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in leisure-time physical activity over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Change in sleep quality over the course of the intervention
Time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)
Program adherence over the course of the intervention
Time frame: Weekly attendance at PASS program sessions over 6 month intervention
Access and use of health services over the course of the intervention
Time frame: Assessed over 6 months (descriptive measure)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Background: PubMed 8037935Andresen EM, Malmgren JA, Carter WB, Patrick DL. Screening for depression in well older adults: evaluation of a short form of the CES-D (Center for Epidemiologic Studies Depression Scale). Am J Prev Med. 1994 Mar-Apr;10(2):77-84.
- Background: PubMed 26653052Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.
- Background: PubMed 15673042Courneya KS, Jones LW, Rhodes RE, Blanchard CM. Effects of different combinations of intensity categories on self-reported exercise. Res Q Exerc Sport. 2004 Dec;75(4):429-33. doi: 10.1080/02701367.2004.10609176. No abstract available.
- BackgroundDallaire RA, Wells DM. The transition to civilian life of veterans. 2014. www.senate-senat.ca/veac.asp
- BackgroundDiener E, Wirtz D, Biswas-Diener R, Tov W, Kim-Prieto C, Choi D-W, Oishi S. New measures of well-being: Short scales to assess flourishing and positive and negative feelings. Soc Indic Res. 2010;97, 143-156.
- BackgroundDoosje B, Ellemers N, Spears R. Perceived intragroup variability as a function of group status and identification. J Exp Soc Psychol. 1995;31(5), 410-436.
- Background: PubMed 32775313Feingold A. New Approaches for Estimation of Effect Sizes and their Confidence Intervals for Treatment Effects from Randomized Controlled Trials. Quant Method Psychol. 2019;15(2):96-111. doi: 10.20982/tqmp.15.2.p096.
- Background: PubMed 19271847Feingold A. Effect sizes for growth-modeling analysis for controlled clinical trials in the same metric as for classical analysis. Psychol Methods. 2009 Mar;14(1):43-53. doi: 10.1037/a0014699.
- Background: PubMed 23956615Feingold A. A Regression Framework for Effect Size Assessments in Longitudinal Modeling of Group Differences. Rev Gen Psychol. 2013 Mar;17(1):111-121. doi: 10.1037/a0030048.
- BackgroundFleeson W. The quality of American life at the end of the century. In Brim OG, Ryff CD, Kessler RC (Eds.), How healthy are we?: A national study of well-being at midlife. 2004. University of Chicago Press.
- Background: PubMed 4053261Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Background: PubMed 19543809Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19.
- Individual participant dataSharing planned: Yes. The protocol for the study is available on the Open Science Framework (embargoed until 31/10/2022, to allow for study completion). The statistical analysis plan is also available on the Open Science Framework (embargoed until 31/10/2022). The consent form is freely available if requested from the Primary Investigator (Beauchamp, M).
Related trials for Well-Being (Psychological Flourishing)
Recruiting
A Mindfulness-based Intervention for Hotel Staff
Well-Being (Psychological Flourishing), Work Related Stress
Not yet recruitingEarly Phase 1
Micropractices for Unhoused LGBTQ Youth
Well-Being (Psychological Flourishing), Internalizing Mental Health Symptoms
Active, not recruiting
Cognitive Training for Student Sleep and Wellness
Sleep, Well-Being (Psychological Flourishing)
Recruiting
Daoist Zhanzhuang and Human Flourishing
Stress, Physiological, Stress, Psychological
Not yet recruiting
How Can We Help? Wellbeing Interventions for Choral Music Ensembles
Anxiety, Well-Being (Psychological Flourishing)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark R Beauchamp, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASS Program Condition: in people with Well-Being (Psychological Flourishing), run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in well-being (psychological flourishing) over the course of the intervention (time frame: Tracked monthly for 6 months (baseline, followed by 6 months of intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289882, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.