Clinical trial NCT06595524: Development of the Online Mindfulness-based Intervention (MFU-Mindful Application) for Thai-university Students
Official title: Development of the Online Mindfulness-based Intervention (MFU-Mindful Application) for Thai-university Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression in Adolescence
Psychological Well-Being
Keywords: depression
mindfulness
psychological well being
university students
Lead sponsor: Mae Fah Luang University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I: one group pre-posttest Phase II: randomized control trial
Primary purpose: PREVENTION

Brief summary: Development of the online mindfulness-based intervention (MFU-mindful application) for Thai university students: Phase I

Objectives:

Phase I: (October 2021 to September 2022)

1. To develop the mindfulness-based intervention (MFU-Mindful application) for Thai university students.
2. To test the feasibility of the mindfulness-based intervention (MFU-Mindful Application) for Thai university students.
3. To determine the effect size of mindfulness-based intervention (MFU-Mindful Application) on mental health outcomes for Thai university students: A pilot study.

Phase II: (October 2022 to December 2024)

1. To examine the effects of mindfulness-base intervention (MFU-Mindful Application) on mental health outcomes for Thai university students

For this research project, investigators will develop the mindfulness-based intervention (MFU-Mindful application) based on mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) by encouraging participants to pay attention to their present thoughts, emotions, feelings, and behaviors without judgment. This attention will help them learn the relationship between their thoughts, emotions, and behaviors and their mental health outcomes (mindfulness, stress, anxiety, and depression) though mindfulness practice (body scan, sitting meditation, and mindful movement using online application). Also, investigators will teach participants how to shape their thoughts and manage their wondering minds and negative and irritable thoughts. Finally, participants will learn how to become an individual with reasonable, flexibility, and positive thoughts.

Population and sample:

Population: Thai university students who are between years 1-4 (undergraduate).

Sample:

Phase I: Mae Fah Luang University students who are studying during the Spring semester, year 2021. We will specifically recruit volunteers who:

Inclusion criteria:

1. are current studying in years 1-4 of undergraduate programs
2. can read, speak, and write in Thai
3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28))
4. have no history of learning disorders (ADHD, other specific learning disorders)
5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders)
6. have no meditation experience within the past 6 months

Exclusion criteria:

1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations)
2. uncomfortable or feel distress and cannot participate in each mindful-based intervention session.


Eligibility criteria: We will specifically recruit volunteers who:

Inclusion Criteria:

1. are current studying in years 1-4 of undergraduate programs
2. can read, speak, and write in Thai
3. be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28))
4. have no history of learning disorders (ADHD, other specific learning disorders)
5. have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders)
6. have no meditation experience within the past 6 months

Exclusion Criteria:

1. have a limitation for mindful movement (hearing loss, blindness, and movement limitations)
2. uncomfortable or feel distress and cannot participate in each mindful-based intervention session.

Primary outcomes:
measure: Suanprung Stress Test-20, SPST-20
timeFrame: baseline-at week 8 (over 8 week)
measure: State-Trait Anxiety Inventory Form Y-1
timeFrame: baseline- at week 8 (over 8 week)
measure: Philadelphia Mindfulness Scale, Thai version
timeFrame: baseline- at week 8 (over 8 week)
measure: Center for Epidemiologic Studies-Depression Scale-Thai version, CES-D-Thai version.
timeFrame: baseline- over 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Rai
country: Thailand
facility: Mae Fah Luang University
state: Chiangrai
Study officials:
References: