Clinical trial NCT06595485: Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
Official title: Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Adolescence
Keywords: depression
Mindfulness
psychological well being
Quality of life
Lead sponsor: Mae Fah Luang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 182
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 \&gt;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

Primary outcomes:
measure: the Children's Depression Inventory (CDI)-Thai version
timeFrame: up to 8 weeks
measure: the Psychological Well-Being Scale-Thai-version
timeFrame: up to 8 weeks
measure: the Five-Facets Mindfulness Questionnaires (FFMQ)
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muang Chiangrai
country: Thailand
facility: Mae Fah Luang University
state: Chiangrai
Study officials:
References: