Depression in AdolescenceNCT06595524
Development of the Online Mindfulness-based Intervention (MFU-Mindful Application) for Thai-university Students
A study testing online mindfulness-based intervention in people with Depression in Adolescence and Psychological Well-Being, run by Mae Fah Luang University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression in Adolescence, Psychological Well-Being
- What is being tested?
- online mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2022to 27 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Development of the online mindfulness-based intervention (MFU-mindful application) for Thai university students: Phase I
Objectives:
Read more
Phase I: (October 2021 to September 2022)
- To develop the mindfulness-based intervention (MFU-Mindful application) for Thai university students.
- To test the feasibility of the mindfulness-based intervention (MFU-Mindful Application) for Thai university students.
- 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)
- 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:
- 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
Exclusion criteria:
- 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.
- Being tested
- online mindfulness-based intervention
- Keywords
- depression, mindfulness, psychological well being, university students
- Medical subject headings
- Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness-based interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| online mindfulness -base intervention | Experimental | Not described Receives: Behavioral: online mindfulness-based intervention |
| waitlist control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline- over 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2022
- Primary completion28 Feb 2024
- Study completion27 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I: one group pre-posttest Phase II: randomized control trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mae Fah Luang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuntana Reangsing, Mae Fah Luang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595524
- Sponsor's protocol ID
- Mae Fah Luang Unviersity
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from law
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Online Mindfulness-based Intervention (MFU-Mindful Application) for Thai-university Students
- ClinicalTrials.gov ID
- NCT06595524
- Acronym / sponsor ID
- Mae Fah Luang Unviersity
- Keywords
- depression, mindfulness, psychological well being, university students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mae Fah Luang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 27 Aug 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Development of the online mindfulness-based intervention (MFU-mindful application) for Thai university students: Phase I
Objectives:
Phase I: (October 2021 to September 2022)
- To develop the mindfulness-based intervention (MFU-Mindful application) for Thai university students.
- To test the feasibility of the mindfulness-based intervention (MFU-Mindful Application) for Thai university students.
- 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)
- 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:
- 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
Exclusion criteria:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase I: one group pre-posttest Phase II: randomized control trial
| Arm | Type | Receives |
|---|---|---|
| online mindfulness -base intervention | Experimental | Behavioral: online mindfulness-based intervention |
| waitlist control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| online mindfulness-based interventionThe 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 | Behavioural | online mindfulness -base intervention |
Primary outcome
Suanprung Stress Test-20, SPST-20
Time frame: baseline-at week 8 (over 8 week)
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
State-Trait Anxiety Inventory Form Y-1
Time frame: baseline- at week 8 (over 8 week)
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.
Philadelphia Mindfulness Scale, Thai version
Time frame: baseline- at week 8 (over 8 week)
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.
Center for Epidemiologic Studies-Depression Scale-Thai version, CES-D-Thai version.
Time frame: baseline- over 8 week
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No. Prohibited from law
Related trials for Depression in Adolescence
Recruiting
The Mindful Smartphone Use Study
Problematic Phone Use Behavior, Depression
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
Not yet recruitingObservational study
Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
Teenthrive 2: Treatments for Improving Mood in Teens
Depression in Adolescence
Recruiting
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online mindfulness-based intervention in people with Depression in Adolescence and Psychological Well-Being, run by Mae Fah Luang University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suanprung Stress Test-20, SPST-20 (time frame: baseline-at week 8 (over 8 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.