Queen's University Belfast, School of Nursing and Midwifery
Belfast, Northern Ireland, BT9 7BL, United Kingdom
NCT Number: NCT07482839
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 period of heightened emotional vulnerability and academic pressure. In Thailand, rising levels of stress and anxiety among young people make school-based preventive interventions a public health priority. While mindfulness-based interventions have shown benefits in Western contexts, evidence on compassion-focused programmes culturally adapted for Thai adolescents remains limited.
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.
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.
This study is active but is not currently recruiting participants.
Notify Me16 year–18 year
All sexes
Interventional
Not applicable
Belfast, Northern Ireland, BT9 7BL, United Kingdom
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).
Technical Application of Participation Models
The research process incorporates established participatory frameworks to assess the depth of stakeholder engagement:
Statistical Analysis Plan
The analysis focuses on determining the feasibility of the protocol for future larger-scale implementation:
Qualitative Process Evaluation To complement quantitative data, a process evaluation will explore the acceptability and contextual relevance of the programme.
Data Security and Transfer Protocols
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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: Adapted CMR-Thai
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Queen's University, Belfast
Other
Feasibility Study of a Compassionate Mindful Resilience (CMR) Intervention to Improve Mental Health Well-being Outcomes Among Youth in Thailand
Acronym: CMR-THAI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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