Mental Health Clinical Trial
Official title:
Evaluating the Hans Kai Program for Canadian Adults Via an 18-month Mixed Methods Randomized Controlled Trial
The Hans Kai trial is a mixed methods randomized controlled trial evaluating the effectiveness of the peer-led health promotion Hans Kai program for Canadian adults with or without chronic health conditions. The Hans Kai trial also aims to identify the strengths and weaknesses of the Hans Kai program as well as the facilitators and barriers to its implementation from the perspectives of the program participants and facilitators. The intervention (Hans Kai program) consists of an 8-week health school that program participants attend to develop health knowledge and skills. Next, program participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a peer-led self-sustaining model. The trial will measure the impact of Hans Kai, compared to waitlist control, on program participants' mental health; social connections; health-related knowledge and empowerment (i.e., self-efficacy and self-determination); health-promoting behaviors (i.e., diet, alcohol consumption, tobacco use, physical activity, and sleep); and clinical measures of cardio-metabolic health.
The Hans Kai trial will follow a prospective mixed methods intervention design involving an RCT and an interpretative descriptive qualitative study. The mixed methods intervention design is a mixed methods approach to research in which the collection, analysis, and integration of both quantitative and qualitative data are embedded within an experimental quantitative research design. The objective of gathering qualitative data within an experiment, along with the quantitative data on the outcome measures, is to gain an understanding of the personal, contextual experiences of the study participants. In this mixed methods intervention study design, quantitative data on the outcomes of interest will be collected along with qualitative data on the experiences of program participants and facilitators, and integrated within an intervention trial (i.e., RCT) to address the research objectives (see next section for details). The primary research design in this study will be a quantitative intervention trial or RCT that will follow a pragmatic randomized wait-list-control design with an 18-month follow-up. The RCT will involve the collection, analysis, and interpretation of quantitative data (self-reports and objective indicators) on primary, secondary, and tertiary outcomes that will be gathered to evaluate the effectiveness of the Hans Kai program in promoting the health and wellbeing of Canadian adults. To enrich the RCT results, the secondary qualitative strand of the study will be added during and after the intervention by embedding a combination of convergent and explanatory sequential designs into the RCT. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
| Completed |
NCT04108689 -
Internet-based Acceptance and Commitment Training for Elite Ice Hockey Players
|
N/A | |
| Recruiting |
NCT06012084 -
The Development and Evaluation of iCF-PWR for Healthy Siblings of Individuals With Cystic Fibrosis
|
N/A | |
| Completed |
NCT04085861 -
Mental Health in Dancers; an Intervention Study
|
N/A | |
| Recruiting |
NCT05227352 -
Bio-Experiential Spaces for Mental Health in Healthworkers
|
N/A | |
| Completed |
NCT03663075 -
Effect of Group Education and Individual Counselling on Mental Health and Quality of Life in 45-60 Year Old Women
|
N/A | |
| Completed |
NCT02480907 -
Supporting Carers of Children and Adolescents With Eating Disorders in Austria (SUCCEAT)
|
N/A | |
| Completed |
NCT02157766 -
Wisconsin Center for the Neuroscience and Psychophysiology of Meditation
|
N/A | |
| Completed |
NCT01155687 -
Psychosocial Counseling in Afghanistan
|
N/A | |
| Unknown status |
NCT01177696 -
Intervention in Groups of Family Caregivers in Primary Health Care
|
N/A | |
| Completed |
NCT01037946 -
Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families
|
N/A | |
| Completed |
NCT00700349 -
Evaluation of Impacts of Access to Credit and Loan Size for Microcredit Clients in South Africa
|
N/A | |
| Recruiting |
NCT03885401 -
Enhanced Care Planning for Patients With Multiple Chronic Conditions
|
N/A | |
| Completed |
NCT03118388 -
Engaging Homeless Youth in Vocational Training to Meet Their Mental Health Needs
|
Phase 2 | |
| Completed |
NCT05061966 -
The Digital Wellbeing Project
|
N/A | |
| Completed |
NCT04026308 -
Written vs Electronic Safety Planning Study
|
N/A | |
| Completed |
NCT04546061 -
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
|
N/A | |
| Completed |
NCT05738109 -
Evaluating the Efficacy of a 91-day Self-talk Mental Health Self-care Journal
|
N/A | |
| Completed |
NCT03901274 -
Partnering for Student Wellness
|
N/A | |
| Not yet recruiting |
NCT05910580 -
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
|
N/A |