- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07482839
Feasibility Study of a Compassionate Mindful Resilience (CMR) Intervention to Improve Mental Health Well-being Outcomes Among Youth in Thailand (CMR-YOUTH-THAI)
This study is a single-arm feasibility trial designed to evaluate the implementation, acceptability, and preliminary effects of a culturally adapted Compassionate Mindful Resilience (CMR) intervention among adolescents in Thailand. The study is conducted in a secondary school setting and targets students aged 16 to 18 years.
Adolescence is a critical developmental period associated with increased emotional vulnerability, academic pressure, and exposure to mental health risks. In Thailand, recent evidence indicates rising levels of stress, anxiety, and reduced psychological well-being among young people. School-based preventive interventions that strengthen internal coping skills are therefore a public health priority. While mindfulness-based interventions have demonstrated benefits in Western contexts, there is limited evidence regarding compassion-focused mindfulness programs that are culturally adapted for Thai adolescents.
The CMR intervention is a structured, manualized behavioral program that integrates mindfulness, self-compassion, and resilience-building skills. The program was originally developed by MindfulnessUK and subsequently adapted for the Thai adolescent context through a co-production process involving students, teachers, and school counselors. Cultural adaptations focused on language use, contextual relevance of examples, and alignment with the Thai educational environment, while maintaining fidelity to the core theoretical framework.
All participants enrolled in the study will receive the CMR intervention. The program consists of four weekly group sessions, each lasting approximately 90 minutes, delivered after school hours to minimize disruption to academic activities. Sessions include guided mindfulness practices, group discussions, and practical exercises aimed at increasing present-moment awareness, cultivating self-compassion, improving emotional regulation, and strengthening resilience. Home practice activities are encouraged between sessions to support skill integration into daily life.
The primary objective of the study is to assess feasibility. Feasibility outcomes include recruitment rate, retention rate, session attendance, intervention fidelity, and participant acceptability. These indicators will inform whether the intervention can be delivered as planned in a Thai school setting and whether progression to a larger-scale trial is justified.
Secondary objectives explore preliminary changes in mental health-related outcomes. These include mindfulness, self-compassion, resilience, and overall well-being, measured using validated Thai-language instruments before and after completion of the intervention. Although the study is not powered to test effectiveness, these data will provide estimates of variability and potential effect sizes to inform the design of a future randomized controlled trial.
Participant safety is addressed through a predefined distress protocol. A school counselor is available during all intervention sessions to provide immediate support if participants experience emotional distress. Ethical approval has been obtained from the relevant institutional ethics committee, and written assent from participants, along with parental or guardian consent, is required prior to enrollment.
Overall, this feasibility study will generate critical information on the practicality, acceptability, and preliminary impact of the Compassionate Mindful Resilience program for adolescents in Thailand. The findings will guide the development of a future definitive trial and contribute to the evidence base for culturally appropriate, school-based mental health promotion interventions in low- and middle-income settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Detailed Description Study Framework and Theoretical Basis This feasibility study constitutes Phase 3 of a comprehensive research project designed to address the rising rates of stress, anxiety, and substance use risks among Thai adolescents. The intervention utilizes the Compassionate Mindful Resilience (CMR) programme, which integrates secular mindfulness with compassion-based approaches to enhance cognitive resilience and emotional regulation. While MBIs have shown efficacy in adult populations, this study evaluates a culturally adapted version specifically for the Thai secondary school context, where collectivist values and Buddhist traditions may influence implementation.
Trial Design and Procedural Workflow The study employs a single-arm, pre-post feasibility design. This approach is selected to evaluate implementation parameters and participant engagement prior to committing to a full-scale randomized controlled trial (RCT).
- Intervention Delivery: The CMR programme consists of eight modules delivered over four weekly 90-minute group sessions. Sessions are conducted after school hours (provisionally 16:00-17:30) to minimize academic disruption and mitigate potential stigma associated with mental health initiatives.
- Fidelity and Facilitation: The programme is delivered by a PhD candidate trained in CMR under academic supervision from Queen's University Belfast. Delivery fidelity is maintained through adherence checklists, session logs, and standardized recap materials for participants who miss sessions.
- Stratified Sampling: To ensure developmental diversity, the study utilizes stratified random sampling across Grades 10, 11, and 12, aimed at achieving a balanced representation from the student population.
Technical Application of Participation Models
The research process incorporates established participatory frameworks to assess the depth of stakeholder engagement:
- Hart's Ladder of Children's Participation: Evaluates whether youth involvement moves beyond tokenism to "Consulted but Informed" and "Adult-Initiated Shared Decisions"
- Arnstein's Ladder of Participation: Used to track the transition toward "Partnership" and "Delegated Power" during the co-production and evaluation phases.
Statistical Analysis Plan
The analysis focuses on determining the feasibility of the protocol for future larger-scale implementation:
- Feasibility Metrics: Recruitment rates, consent rates, session attendance, and participant retention will be analyzed using descriptive statistics.
- Preliminary Effectiveness: Quantitative changes in psychosocial outcomes will be assessed using paired t-tests or non-parametric equivalents. Effect sizes (Cohen's d) will be calculated to estimate the magnitude of change for future power calculations.
- Exposure Analysis: An exploratory subset analysis will be reported for participants who attend at least 75% of the sessions (three out of four) to investigate dose-response relationships.
Qualitative Process Evaluation To complement quantitative data, a process evaluation will explore the acceptability and contextual relevance of the programme.
- Thematic Analysis: Post-intervention focus groups and brief exit interviews will be audio-recorded, transcribed verbatim in Thai, and translated into English.
- Analytical Rigor: Qualitative data will be managed using NVivo software and analyzed via Reflexive Thematic Analysis. A second coder will review a subset of transcripts to ensure credibility and an audit trail will be maintained.
Data Security and Transfer Protocols
- Pseudonymization: All data are de-identified at the source using study codes; identifiable information remains in Thailand and is not transferred.
- Electronic Management: Scanned documents and audio transcripts are stored on encrypted, password-protected systems with role-based access.
- Cross-Border Transfer: Pseudonymized data transferred for analysis utilize encrypted channels in compliance with university governance and data protection legislation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Oliver Perra, PhD
- Phone Number: +44 (0)28 9097 2313
- Email: o.perra@qub.ac.uk
Study Contact Backup
- Name: Patricia Carlisle, PhD
- Phone Number: +44 (0)28 9097 1379
- Email: p.carlisle@qub.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents between 16 and 18 years of age at the time of enrollment.
- Current students in Grades 10 to 12 (Mathayom 4-6) at a Thai Secondary School in Northeastern Thailand.
- Willingness to engage in a mindfulness-based intervention programme.
- Ability to understand and communicate in the Thai language.
- Ability to provide informed consent (dual consent from both the student and a parent/legal guardian is required).
Exclusion Criteria:
- Significant mental health conditions that may impede participation, such as schizophrenia, bipolar I disorder, or severe major depression with psychotic features.
- Cognitive impairments that prevent comprehension of the mindfulness intervention.
- Concurrent involvement in another psychological intervention that might confound the study results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Compassionate Mindful Resilience (CMR) Experimental Group
|
A group-based behavioral intervention delivered over four weekly 90-minute sessions (6 hours total contact time). The program integrates mindfulness, self-compassion, and resilience training through eight modules. Technical components include:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment Rate
Time Frame: Week 0 (at the end of recruitment)
|
This measure represents the proportion of eligible students who provide informed consent.
It is measured as a percentage, calculated as: (Number of Consented Participants / Number of Eligible Students Invited) x 100.
The target for success is a recruitment rate of 70% or higher.
|
Week 0 (at the end of recruitment)
|
|
Retention Rate
Time Frame: Week 4 (post-intervention).
|
This measure represents the proportion of enrolled participants who complete the study and provide post-intervention data.
It is measured as a percentage, calculated as: (Number of Participants Providing Post-Intervention Data / Number Enrolled) x 100.
The target for success is a retention rate of 80% or higher.
|
Week 4 (post-intervention).
|
|
Session Attendance
Time Frame: From start to end of the intervention (Week 1 to Week 4).
|
This measure tracks participant adherence based on the total number of sessions attended.
It is calculated as the mean number of sessions attended out of the 4 scheduled sessions.
Scores range from 0 to 4 sessions, where a higher number indicates greater attendance.
|
From start to end of the intervention (Week 1 to Week 4).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Mindfulness Scores (Srithanya Sati Scale)
Time Frame: Baseline (Week 0) and Post-intervention (Week 4).
|
This outcome assesses the change in dispositional mindfulness using the Srithanya Sati Scale, an 11-item self-report questionnaire.
The total score is calculated as the sum of all 11 items.
The minimum score is 11 and the maximum score is 44.
Higher scores indicate greater levels of mindfulness.
The "Change" is calculated by subtracting the Baseline (Week 0) total score from the Post-intervention (Week 4) total score.
|
Baseline (Week 0) and Post-intervention (Week 4).
|
|
Change in Self-Compassion Scores (SCS-Y Thai version)
Time Frame: Baseline (Week 0) and Post-intervention (Week 4)
|
This outcome assesses the change in how youth treat themselves with kindness during difficult times using a 17-item scale.
Each item is rated on a 5-point scale.
The total score is calculated as the mean of all 17 items (after reverse-scoring negative items).
The minimum score is 1.0 and the maximum score is 5.0.
Higher scores indicate higher levels of self-compassion.
The "Change" is calculated by subtracting the Baseline (Week 0) mean score from the Post-intervention (Week 4) mean score.
|
Baseline (Week 0) and Post-intervention (Week 4)
|
|
Change in Resilience Scores (CD-RISC-10)
Time Frame: Baseline (Week 0) and Post-intervention (Week 4)
|
This outcome assesses the change in psychological resilience using a 10-item scale.
Each item is rated on a 5-point scale (0-4).
The total score is calculated as the sum of all 10 items.
The minimum score is 0 and the maximum score is 40.
Higher scores represent greater psychological resilience.
The "Change" is calculated by subtracting the Baseline (Week 0) total score from the Post-intervention (Week 4) total score.
|
Baseline (Week 0) and Post-intervention (Week 4)
|
|
Change in Subjective Well-being (WHO-5 Well-being Index)
Time Frame: Baseline (Week 0) and Post-intervention (Week 4)
|
This outcome measures the change in subjective psychological well-being using a 5-item scale.
The total score is calculated as the raw sum of the 5 items.
The minimum score is 0 and the maximum score is 25.
Higher scores indicate better subjective well-being.
The "Change" is calculated by subtracting the Baseline (Week 0) raw score from the Post-intervention (Week 4) raw score.
|
Baseline (Week 0) and Post-intervention (Week 4)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualitative Assessment of Intervention Acceptability: Focus Groups
Time Frame: Within 2 weeks post-intervention (Week 5-6).
|
Semi-structured post-intervention focus groups will be conducted to explore participants' perceptions of the programme's relevance, delivery format, and overall value.
Data will be analyzed using thematic analysis to identify recurring themes regarding shifts in emotional regulation skills, stress management, and the real-world application of CMR strategies.
Unit of Measure: Qualitative themes.
|
Within 2 weeks post-intervention (Week 5-6).
|
|
Qualitative Exploration: Barriers to Engagement (Low-Attendance Interviews)
Time Frame: Within 2 weeks post-intervention (Week 5-6).
|
Semi-structured interviews with participants attending <3 sessions to identify structural or personal barriers.
Unit of Measure: Qualitative themes identified through thematic analysis.
|
Within 2 weeks post-intervention (Week 5-6).
|
|
Qualitative Assessment of Substance Use Coping and Behaviors
Time Frame: Within 2 weeks post-intervention (Week 5-6).
|
This outcome explores participants' perceptions of changes in their substance use behaviors and their ability to apply Compassionate Mindful Resilience (CMR) strategies to cope with peer or family substance exposure.
Data will be collected through semi-structured focus groups and interviews (as outlined in the Focus Group Guide).
Analysis will focus on themes such as the application of "urge surfing" and emotional regulation in high-risk situations.
Unit of Measure: Qualitative themes identified through thematic analysis.
|
Within 2 weeks post-intervention (Week 5-6).
|
|
Qualitative Assessment of Intervention Acceptability: Exit Interviews
Time Frame: Within 2 weeks post-intervention (Week 5-6).
|
Brief individual exit interviews will be conducted post-intervention to gather specific feedback on the participant's personal experience with the intervention. The analysis will focus on identifying individual perspectives regarding the intervention's feasibility, perceived impact on daily life, and suggestions for program improvement. Unit of Measure: Qualitative themes identified through thematic analysis. |
Within 2 weeks post-intervention (Week 5-6).
|
|
Change in Long-term Subjective Well-being (WHO-5)
Time Frame: Baseline (Week 0) and 3 months post-intervention.
|
To evaluate sustained impact, the WHO-5 Well-being Index will be re-administered.
The score is calculated as the raw sum of the 5 items.
The minimum score is 0 and the maximum score is 25.
Higher scores indicate better subjective well-being.
The "Change" is calculated by subtracting the Baseline (Week 0) raw score from the 3-month follow-up raw score.
|
Baseline (Week 0) and 3 months post-intervention.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Oliver Perra, PhD, Queen's University, Belfast
Publications and helpful links
General Publications
- Kabat-Zinn, J. (2003). Mindfulness-Based interventions in context: Past, present, and future. Clinical Psychology: Science and Practice, 10(2), 144-156.
- Hart, R. A. (1992). Children's participation: From tokenism to citizenship. UNICEF Innocenti Research Centre.
- Vongsirimas, N., et al. (2017). Evaluating Psychometric Properties of the Connor-Davidson Resilience Scale (10-Item CD-RISC) among University Students in Thailand. Nursing Science Journal of Thailand, 35(3), 25-35.
- Silpakit O, Silpakit C. A thai version of mindfulness questionnaire: Srithanya Sati scale. East Asian Arch Psychiatry. 2014 Mar;24(1):23-9.
- Wilson, A., et al. (2023). Experiences of People with Kidney Disease Following the Implementation of the Compassionate Mindful Resilience Programme: Qualitative Findings from the COSMIC Study. Healthcare, 11(22), 2926.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHLS 25_106
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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