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

NCT06595485 | Completed DMC

• 1 other identifier: Mae Fah Luang Unviersity_002
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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

Conditions

Depression in Adolescence

Keywords

depression; Mindfulness; psychological well being; Quality of life

Outcome Measures

Primary Outcomes (3)

• the Children's Depression Inventory (CDI)-Thai version

  a self-reported questionnaire. The scale comprises 27 items with 3-point answers to represent level of depression over the last 2 weeks ago. Participants will rate themselves based on how they feel and think, which each statement being identified with a scale from 0 to 2. A score of 15 or higher is generally accepted to reflect a person who has depression (cut point). Participants will take approximately 10-20 minutes to complete the CDI. The CDI has been widely used among Thai populations with support for validity and good internal consistency (Alpha Cronbach = 0.82, Reangsing, 2011)

  up to 8 weeks

• the Psychological Well-Being Scale-Thai-version

  PWB-S, is developed by Ryff (1989) and back-translation by Klainin-Yobas et al. (2020). The scale is comprised of 18 items with 6 subscales including autonomy, environmental mastery, purpose of life, personal growth, positive relations with other, and self-acceptance. Participants will rate themselves based on how they feel and perception, which each item ranging from (1) strongly disagree to (6) strongly agree. Possible scores are range from 18 to 108, with higher scores indicating psychological well-being. This scale has support for validity and acceptant reliability (Alpha Cronbach=.70-.85, Klainin-Yobas et al., 2020)

  up to 8 weeks

• the Five-Facets Mindfulness Questionnaires (FFMQ)

  using the Five-Facets Mindfulness Questionnaires (FFMQ) which is a self-report instrument developed by Baer et al. (2008). This scale consists of 39 items, with 5 sub-domains of mindfulness including observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Participants will rate each statement with a number that best describes themselves as scale from never or very rarely true (1) to very often or always true (5). The total FFMQ can be divided by 39 to get an average score of mindfulness (Baer et al., 2006). Higher score indicates high of mindfulness level. This scale has been used among Thai people with a good reliability (Alpha Cronbach = .93, Rattanaphet et al., 2016)

  up to 8 weeks

Study Arms (2)

online mindfulness -base intervention

EXPERIMENTAL

Behavioral: online mindfulness based intervention

waitlist control group

NO INTERVENTION

Interventions

online mindfulness based intervention 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

online mindfulness -base intervention

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• We will include adolescents who
• are between 12 to 20 years of age;
• have depressive symptoms (the Children Depressive Inventory \[CDI\] Score \>15);
• are proficient in Thai;
• have smartphone with iOS/android platform, and
• volunteer

You may not qualify if:

• We will exclude adolescents if they have:
• 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,
• regularly practiced of MBI within the past six months, and
• lack of access to online MBI application or to Skype technology for online discussion group

Sponsors & Collaborators

• Mae Fah Luang University: lead

Study Sites (1)

Mae Fah Luang University

Muang Chiangrai, Chiangrai, 57100, Thailand

Location

MeSH Terms

Conditions

Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: we will collected outcomes via online application
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: January 19, 2022
• Primary Completion: January 19, 2023
• Study Completion: December 31, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)