NCT07482839

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started May 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Dec 2027

First Submitted

Initial submission to the registry

February 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

February 12, 2026

Last Update Submit

April 18, 2026

Conditions

Keywords

Compassionate Mindful Resilience (CMR)Mindfulness-Based Intervention (MBI)AdolescentsThailandSecondary SchoolFeasibility StudyCo-productionSelf-compassionYouth Mental Health

Outcome Measures

Primary Outcomes (3)

  • Recruitment Rate

    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

    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

    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 Outcomes (4)

  • 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)

Other Outcomes (5)

  • Qualitative Assessment of Intervention Acceptability: Focus Groups

    Within 2 weeks post-intervention (Week 5-6).

  • Qualitative Exploration: Barriers to Engagement (Low-Attendance Interviews)

    Within 2 weeks post-intervention (Week 5-6).

  • Qualitative Assessment of Substance Use Coping and Behaviors

    Within 2 weeks post-intervention (Week 5-6).

  • +2 more other outcomes

Study Arms (1)

Compassionate Mindful Resilience (CMR) Experimental Group

EXPERIMENTAL

* 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.

Behavioral: Four-Week Compassionate Mindful Resilience (CMR) Intervention

Interventions

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: * Mindfulness \& Awareness: Breathing practices, body scans, and "being mode" vs "doing mode". * Emotional Intelligence: Application of the RAIN (Recognise, Acknowledge, Investigate, Nurture), HEARTS, and STOP (Stop, Take a breath, Observe, Proceed) models. * Resilience Building: Cognitive reappraisal, affectionate breathing, and social connection strategies. * Impulse Management: "Urge surfing" meditations and mindful decision-making to support substance-use prevention. * Home Practice: Daily 10-minute meditation, journaling, and mindful movement.

Also known as: Adapted CMR-Thai
Compassionate Mindful Resilience (CMR) Experimental Group

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Kabat-Zinn, J. (2003). Mindfulness-Based interventions in context: Past, present, and future. Clinical Psychology: Science and Practice, 10(2), 144-156.

    BACKGROUND
  • Hart, R. A. (1992). Children's participation: From tokenism to citizenship. UNICEF Innocenti Research Centre.

    BACKGROUND
  • 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.

    BACKGROUND
  • Silpakit O, Silpakit C. A thai version of mindfulness questionnaire: Srithanya Sati scale. East Asian Arch Psychiatry. 2014 Mar;24(1):23-9.

    PMID: 24676484BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Interventions

Methods

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Oliver Perra, PhD

    Queen's University, Belfast

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Perra, PhD

CONTACT

Patricia Carlisle, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This feasibility study utilizes a single-arm pre-post design to evaluate the implementation and acceptability of a 4-week CMR intervention. While the ultimate goal is a cluster randomized controlled trial (RCT), this stage focuses on feasibility metrics within a single school setting to inform the design of future larger trials.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer in Perinatal Health & Wellbeing School of Nursing & Midwifery

Study Record Dates

First Submitted

February 12, 2026

First Posted

March 19, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Pseudonymized individual participant data that underlie the results reported in academic publications may be made available to researchers who provide a methodologically sound proposal.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The pseudonymized study results and supporting documentation (Protocol and Informed Consent Forms) will become available upon the completion of the study and subsequent publication of results in peer-reviewed journals, anticipated in 2026. These materials will be maintained on the Queen's Research Portal for at least the duration required by university research governance and open-access policies. Participants may request the deletion of their individual data only up to 7 days after the end of all data-collection activities, after which data is de-identified and aggregated for analysis.
Access Criteria
Aggregated findings and research outputs will be available to the general public, educators, and policymakers through open-access academic publications and the institutional repository. While raw individual participant data (IPD) will not be shared to protect the privacy of the minors involved, the Study Protocol (v3.1) and Informed Consent Forms may be accessed by researchers and stakeholders via the Queen's Research Portal. Requests for further technical information regarding the cultural adaptation process or feasibility metrics can be directed to the Research Ethics Officer or the Principal Investigator.
More information