Development of the Online Mindfulness-based Intervention (MFU-Mindful Application) for Thai-university Students

NCT06595524 | Completed DMC

• 1 other identifier: Mae Fah Luang Unviersity
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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. 1.To develop the mindfulness-based intervention (MFU-Mindful application) for Thai university students.
2. 2.To test the feasibility of the mindfulness-based intervention (MFU-Mindful Application) for Thai university students.
3. 3.To determine the effect size of mindfulness-based intervention (MFU-Mindful Application) on mental health outcomes for Thai university students: A pilot study.
4. 4.are current studying in years 1-4 of undergraduate programs
5. 5.can read, speak, and write in Thai
6. 6.be risk of the mental health problem (score higher than 6 on the General Health Questionnaire (GHQ-28))
7. 7.have no history of learning disorders (ADHD, other specific learning disorders)
8. 8.have no psychiatric disorders (schizophrenia, adjustment disorders, delusion disorders, and substance use disorders)
9. 9.have no meditation experience within the past 6 months
10. 10.have a limitation for mindful movement (hearing loss, blindness, and movement limitations)
11. 11.uncomfortable or feel distress and cannot participate in each mindful-based intervention session.

Conditions

Depression in Adolescence; Psychological Well-Being

Keywords

depression; mindfulness; psychological well being; university students

Outcome Measures

Primary Outcomes (4)

• Suanprung Stress Test-20, SPST-20

  This is a self-administered questionnaire consisting of 20 items, which was adapted and translated into Thai by Mahatnirunkul et al. (1997). This scale provides one score reflecting sensitivity to stress, sources of stress, and physiological reactions to stress (e.g., muscular stress, nervous systems, emotional stress, and cognitive stress). This scale measures how much daily activities produce work-related stress and individuals' responses to stress. Respondents are asked to choose from five possible responses in a format requiring them to describe how they feel at this very moment on a 5-point intensity scale: 1 = no stress, 2 = mild stress, 3, = moderate stress, 4 = much stress, and 5=extreme stress. Higher scores indicate higher levels of stress. Researchers have divided the SPST-20 stress scores into four levels: 0-24, mild; 25-42, moderate; 43-62, high; and over 63, severe stress (Mahatnirunkul et al., 1997). Cronbach's alpha was reported to be more than .7 (Jitvaropas et al., 2

  baseline-at week 8 (over 8 week)

• State-Trait Anxiety Inventory Form Y-1

  STAI form -1, Thai version. This scale is a self-report questionnaire developed by Spielberger and Sydeman (1994) and was translated into Thai by Thapinta (1991). This scale consists of 20 items including 10-positive items and 10-negative items. Respondents are asked to choose from four possible responses in a format requiring them to describe how they feel at this very moment on a 4-point intensity scale: 1 = not at all, 2 = somewhat, 3, = moderately, 4 = very much. Thus, possible scores ranged from 1 to 80. Higher scores indicate higher anxiety (Thapinta, 1991). For this study, the Cronbach's alpha coefficient was .80.

  baseline- at week 8 (over 8 week)

• Philadelphia Mindfulness Scale, Thai version

  This scale is a self-report questionnaire with 20 items, which was developed and translated by Silpakit et al. (2004). It consists of 2 subscales, awareness and acceptance, with response options from 1 to 5 (1=never, 2=rarely, 3=sometimes, 4=often, and 5=very often). A higher score indicates a higher mindfulness level. The Cronbach's alpha coefficient of awareness and acceptance among Thai-population were .87 and .88, respectively (Silpakit et al., 2004). For this study, the Cronbach's alpha coefficient was 0.92 for the total score.

  baseline- at week 8 (over 8 week)

• Center for Epidemiologic Studies-Depression Scale-Thai version, CES-D-Thai version.

  CES-D Thai version is a self-report questionnaire with a total of 20 items, which was developed by the Center for Epidemiologic Studies at the U.S. National Institute of Mental Health and was translated and adapted into Thai by Trangkasombat et al. (1997). The reliability of this instrument was .86 among Thai adolescents (Trangkasombat et al., 1997). Respondents are asked to choose from four possible responses where 0 = rarely or none of the time (less than 1 day), and 4 = almost or all of the time (5 to 7 days). A total score is calculated by summing all items providing a possible range from 0 to 60. Higher scores reflect greater levels of depressive symptoms. The CES-D has 4 separate subscales: positive affect, negative affect, somatic symptoms, and interpersonal relations. Items on the positive affect subscale are reversed to reflect 'unhappy' or 'lack of well-being' (Trangkasombat et al., 1997). The CES-D has good internal consistency with alphas of 0.85 for the general population

  baseline- over 8 week

Study Arms (2)

online mindfulness -base intervention

EXPERIMENTAL

Behavioral: online mindfulness-based intervention

waitlist control group

NO INTERVENTION

Interventions

online mindfulness-based intervention BEHAVIORAL

The mindfulness-based intervention (MFU-Mindful-application) consists of 8 topics, one topic per week. Moreover, we will assign participants (experimental group) to continuously practice using guided meditation approximately 10 minutes daily at least 5 days a week for 3 months via MFU-Mindful application

online mindfulness -base intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mae Fah Luang University: lead

Study Sites (1)

Mae Fah Luang University

Chiang Rai, Chiangrai, 57100, Thailand

Location

MeSH Terms

Conditions

Psychological Well-Being; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: collecting all outcomes at baseline and post-intervention by using online web-based method
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Phase I: one group pre-posttest Phase II: randomized control trial

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2022
• Primary Completion: February 28, 2024
• Study Completion: August 27, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)