NCT07346612

Brief Summary

Development of the online mindfulness-based intervention (MFU-mindful Application for Thai university students: Phase II Objectives: Phase I: (October 2025 to September 2026)

  1. 1.To develop the mindfulness-based intervention (Mind Space application) for Thai university students.
  2. 2.To test the feasibility of the mindfulness-based intervention (Mind space Application) for Thai university students.
  3. 3.To determine the effect size of mindfulness-based intervention (Mind space Application) on mental health outcomes for Thai university students: A pilot study. Phase II: (October 2026 to December 2026)
  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.They may feel uncomfortable or distressed and may not be able to participate in each mindfulness-based intervention session.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Feb 2026Sep 2027

First Submitted

Initial submission to the registry

December 22, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

December 22, 2025

Last Update Submit

January 7, 2026

Conditions

Keywords

university studentsdepressionpsychological well being

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

    Baseline-at 8 weeks [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 - 8 week [over 8 wks]

  • 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- 8 weeks [over 8 weeks]

  • 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 - 8 weeks [over 8 wks]

Study Arms (2)

Experimental: online mindfulness-based intervention

EXPERIMENTAL

online mindfulness-based intervention The mindfulness-based intervention (mind space) consists of 8 topics, one topic per week. Moreover, the researchers 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

Behavioral: mind space intervention

Waitlist control group

NO INTERVENTION

no intervention

Interventions

online mindfulness-based intervention The mindfulness-based intervention (MFU-Mindfulapplication) consists of 8 topics, one topic per week. Moreover, the researchers 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

Experimental: online mindfulness-based intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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 mindfulness-based intervention session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, Mae Fah Luang University

Chiang Rai, Chiangrai, 57100, Thailand

Location

MeSH Terms

Conditions

Psychological Well-BeingDepression

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral Symptoms

Central Study Contacts

Chuntana no Reangsing, Ph.D, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor) collecting all outcomes at baseline and post-intervention by using online web based method
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator, School of Nursing, Mae Fah Luang University, Thailand

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 16, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Prohibit from law

Locations