Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents

NCT ID: NCT06595485

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-19
• Study Completion Date: 2023-12-31

Brief Summary

Project: "Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents"

For this project we adopted Kabat-Zinn's definition of mindfulness as the intentional and non-judgmental awareness of thoughts, feelings, and sensations that specifically occur in the present moment (Kabat-Zinn, 2003). We hope to help depressed Thai adolescents begin to develop mindfulness as part of their habitual attention and hone present-moment awareness through mindfulness practicing. For their practice, they will be taught to maintain an awareness of their thoughts, emotions, and physical sensations, and relate these to the negative thoughts that typically contribute to the onset of their depression. We believe this will help Thai adolescents better understand the relationship between their thoughts and their depressive symptoms. Once they understand these relationships, their practice will help them become more flexible, reasonable, and positive.

This project will consist of two phases. Phase I: Using the established literature and qualitative interviews and focus groups, we will design, and pilot test an online MBI. In Phase II, we will evaluate the effectiveness of the online MBI by randomizing depressed Thai adolescent volunteers into one of two groups: an online MBI (intervention group) and a usual care waitlist control group (N=182). Depression, grade, well-being, and mindfulness will be measure at four-time points; baseline, immediately post-intervention, and 3- and 6-months post-intervention

Detailed Description

Phase I: To develop and pilot test an online mindfulness-based intervention.

• 10 depressed adolescents for in-depth interviews and 10 stakeholders (2 teachers, 3 school health providers/nurses, 2 mental health and psychiatric instructors, and 3 parents of adolescents) for focus groups to develop and customize the online MBI to adolescents.
• 20 depressed adolescents, randomized to two groups (10 each), to pilot test the study for phase II.

Phase II: To evaluate the effects of the online MBI on depressive symptoms, mindfulness, grade, and well-being among depressed Thai adolescents.

• Quantitative sample: 182 Thai-adolescents with depression randomized to two groups (91 each), to test the effectiveness and efficacy of the online MBI.
• Qualitative sample: 20 Thai adolescents with depression for in-depth interview and focus group to get the adolescents' perceptions of the effectiveness of the online MBI.

Conditions

Depression in Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

online mindfulness -base intervention

Group Type: EXPERIMENTAL

online mindfulness based intervention

Intervention Type: BEHAVIORAL

We anticipate the online MBI to be 10-20 minutes once daily, at least 5 days per week, for 8 weeks. Online MBI will be available free of charge on iOS and Android platforms. Participants will be instructed to download the app and use for practices. The online MBI group will be introduced to practice including mindful breathing (simple attention to the flow of the breath, inhalations, and exhalations), body scan (attention and awareness of different body parts) and practice of non-judgement of thoughts and emotions and guided meditation (sitting meditation). In addition, we anticipate participants in MBI group will have a group discussion via skype, 30 minute a week for 8 weeks. Moreover, we anticipate participants in MBI group to record how they practice in each day (attendance) as home assignment using online MBI application. For the details of mindfulness practice, we will develop based on data from interview and focus group

waitlist control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

online mindfulness based intervention

We anticipate the online MBI to be 10-20 minutes once daily, at least 5 days per week, for 8 weeks. Online MBI will be available free of charge on iOS and Android platforms. Participants will be instructed to download the app and use for practices. The online MBI group will be introduced to practice including mindful breathing (simple attention to the flow of the breath, inhalations, and exhalations), body scan (attention and awareness of different body parts) and practice of non-judgement of thoughts and emotions and guided meditation (sitting meditation). In addition, we anticipate participants in MBI group will have a group discussion via skype, 30 minute a week for 8 weeks. Moreover, we anticipate participants in MBI group to record how they practice in each day (attendance) as home assignment using online MBI application. For the details of mindfulness practice, we will develop based on data from interview and focus group

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

We will include adolescents who

1. are between 12 to 20 years of age;

2. have depressive symptoms (the Children Depressive Inventory [CDI] Score >15);

3. are proficient in Thai;

4. have smartphone with iOS/android platform, and

5. volunteer

Exclusion Criteria

We will exclude adolescents if they have:

1. current presence of physical or mental conditions, such as learning disorders, major depressive disorders (MDD), bipolar disorders, and drug addiction or abuse, all of which make full participation in all aspects of this study questionable,

2. regularly practiced of MBI within the past six months, and

3. lack of access to online MBI application or to Skype technology for online discussion group

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mae Fah Luang University

OTHER

Sponsor Role: lead

Responsible Party

Chuntana Reangsing

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mae Fah Luang University

Muang Chiangrai, Chiangrai, Thailand

Countries

Thailand

Other Identifiers

Mae Fah Luang Unviersity_002

Identifier Type: -

Identifier Source: org_study_id