Feasibility Study of a Compassionate Mindful Resilience (CMR) Intervention to Improve Mental Health Well-being Outcomes Among Youth in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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.
详细描述
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 (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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
As this is a single-arm feasibility study, it is conducted as an open-label trial. There is no masking of participants or the investigator. Specific details regarding the open-label nature include:
- Intervention Delivery: The PhD researcher facilitates the sessions and collects all primary data, making masking of the investigator impossible.
- Participant Awareness: Students are fully informed of the Compassionate Mindful Resilience (CMR) content during the information session and through the Participant Information Sheet prior to consent.
- Absence of Control Group: Since no control group or placebo is utilized in this feasibility stage, there is no allocation concealment.
- Qualitative Analysis: The investigator also conducts the focus group discussions and exit interviews, ensuring transparency in participant interaction.
- Data Integrity: To reduce bias during analysis, quantitative data from questionnaires are pseudonymized at the source using study codes.
入排标准
- 年龄范围
- 16 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Compassionate Mindful Resilience (CMR) Experimental Group
- This single-arm group will receive a culturally adapted, 4-week Compassionate Mindful Resilience (CMR) intervention.
- Participants include 46 secondary school students (Aged 16-18) from Grades 10 to 12.
- The intervention consists of four weekly 90-minute group sessions delivered after school hours (approximately 16:00-17:30).
- Participants engage in mindfulness fundamentals, emotional intelligence training (RAIN and HEARTS models), and resilience strategies.
- Home practices include 10-minute daily breathing exercises, journaling, and body scan meditations.
- The arm focuses on evaluating recruitment, retention, and the acceptability of the programme in a Thai school context.
干预措施: Four-Week Compassionate Mindful Resilience (CMR) Intervention (Behavioral)
结局指标
主要结局
Recruitment Rate
时间窗: 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.
Retention Rate
时间窗: 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.
Session Attendance
时间窗: 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.
次要结局
- Change in Mindfulness Scores (Srithanya Sati Scale)(Baseline (Week 0) and Post-intervention (Week 4).)
- Change in Self-Compassion Scores (SCS-Y Thai version)(Baseline (Week 0) and Post-intervention (Week 4))
- Change in Resilience Scores (CD-RISC-10)(Baseline (Week 0) and Post-intervention (Week 4))
- Change in Subjective Well-being (WHO-5 Well-being Index)(Baseline (Week 0) and Post-intervention (Week 4))
研究者
Oliver Perra
Senior Lecturer in Perinatal Health & Wellbeing School of Nursing & Midwifery
Queen's University, Belfast