Depression in AdolescenceNCT06595485
Development of Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
A study testing online mindfulness based intervention in people with Depression in Adolescence, run by Mae Fah Luang University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression in Adolescence
- 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
- 182 participants
- Where
- 1 siteThailand
- Study dates
- 19 Jan 2022to 31 Dec 2023
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- We will include adolescents who
- are between 12 to 20 years of age;
- have depressive symptoms (the Children Depressive Inventory [CDI] Score \>15);
- are proficient in Thai;
- have smartphone with iOS/android platform, and
- volunteer
Who cannot join
- We will exclude adolescents if they have:
- 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,
- regularly practiced of MBI within the past six months, and
- lack of access to online MBI application or to Skype technology for online discussion group
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Depression in Adolescence
- Being tested
- online mindfulness based intervention
- Keywords
- depression, Mindfulness, psychological well being, Quality of life
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online mindfulness based interventionBehavioural
We anticipate the online MBI to be 10-20 minutes once daily, at least 5 days per week, for 8 weeks. Online MBI will be available free of charge on iOS and Android platforms. Participants will be instructed to download the app and use for practices. The online MBI group will be introduced to practice including mindful breathing (simple attention to the flow of the breath, inhalations, and exhalations), body scan (attention and awareness of different body parts) and practice of non-judgement of thoughts and emotions and guided meditation (sitting meditation). In addition, we anticipate participants in MBI group will have a group discussion via skype, 30 minute a week for 8 weeks. Moreover, we anticipate participants in MBI group to record how they practice in each day (attendance) as home assignment using online MBI application. For the details of mindfulness practice, we will develop based on data from interview and focus group
| 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.
the Children's Depression Inventory (CDI)-Thai version
a self-reported questionnaire. The scale comprises 27 items with 3-point answers to represent level of depression over the last 2 weeks ago. Participants will rate themselves based on how they feel and think, which each statement being identified with a scale from 0 to 2. A score of 15 or higher is generally accepted to reflect a person who has depression (cut point). Participants will take approximately 10-20 minutes to complete the CDI. The CDI has been widely used among Thai populations with support for validity and good internal consistency (Alpha Cronbach = 0.82, Reangsing, 2011)
Measured: up to 8 weeks
the Psychological Well-Being Scale-Thai-version
PWB-S, is developed by Ryff (1989) and back-translation by Klainin-Yobas et al. (2020). The scale is comprised of 18 items with 6 subscales including autonomy, environmental mastery, purpose of life, personal growth, positive relations with other, and self-acceptance. Participants will rate themselves based on how they feel and perception, which each item ranging from (1) strongly disagree to (6) strongly agree. Possible scores are range from 18 to 108, with higher scores indicating psychological well-being. This scale has support for validity and acceptant reliability (Alpha Cronbach=.70-.85, Klainin-Yobas et al., 2020)
Measured: up to 8 weeks
the Five-Facets Mindfulness Questionnaires (FFMQ)
using the Five-Facets Mindfulness Questionnaires (FFMQ) which is a self-report instrument developed by Baer et al. (2008). This scale consists of 39 items, with 5 sub-domains of mindfulness including observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Participants will rate each statement with a number that best describes themselves as scale from never or very rarely true (1) to very often or always true (5). The total FFMQ can be divided by 39 to get an average score of mindfulness (Baer et al., 2006). Higher score indicates high of mindfulness level. This scale has been used among Thai people with a good reliability (Alpha Cronbach = .93, Rattanaphet et al., 2016)
Measured: up to 8 weeks
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 start19 Jan 2022
- Primary completion19 Jan 2023
- Study completion31 Dec 2023
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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 182 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
- NCT06595485
- Sponsor's protocol ID
- Mae Fah Luang Unviersity_002
- 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 Online Mindfulness-Based Intervention for Thai-Depressed Adolescents
- ClinicalTrials.gov ID
- NCT06595485
- Acronym / sponsor ID
- Mae Fah Luang Unviersity_002
- Conditions
- Depression in Adolescence
- Keywords
- depression, Mindfulness, psychological well being, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Mae Fah Luang UniversityUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 31 Dec 2023 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| online mindfulness -base intervention | Experimental | Behavioral: online mindfulness based intervention |
| waitlist control group | No intervention | – |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- We will include adolescents who
- are between 12 to 20 years of age;
- have depressive symptoms (the Children Depressive Inventory [CDI] Score \>15);
- are proficient in Thai;
- have smartphone with iOS/android platform, and
Key exclusion criteria (4 listed)
- 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,
- regularly practiced of MBI within the past six months, and
- lack of access to online MBI application or to Skype technology for online discussion group
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 interventionWe anticipate the online MBI to be 10-20 minutes once daily, at least 5 days per week, for 8 weeks. Online MBI will be available free of charge on iOS and Android platforms. Participants will be instructed to download the app and use for practices. The online MBI group will be introduced to practice including mindful breathing (simple attention to the flow of the breath, inhalations, and exhalations), body scan (attention and awareness of different body parts) and practice of non-judgement of thoughts and emotions and guided meditation (sitting meditation). In addition, we anticipate participants in MBI group will have a group discussion via skype, 30 minute a week for 8 weeks. Moreover, we anticipate participants in MBI group to record how they practice in each day (attendance) as home assignment using online MBI application. For the details of mindfulness practice, we will develop based on data from interview and focus group | Behavioural | online mindfulness -base intervention |
Primary outcome
the Children's Depression Inventory (CDI)-Thai version
Time frame: up to 8 weeks
a self-reported questionnaire. The scale comprises 27 items with 3-point answers to represent level of depression over the last 2 weeks ago. Participants will rate themselves based on how they feel and think, which each statement being identified with a scale from 0 to 2. A score of 15 or higher is generally accepted to reflect a person who has depression (cut point). Participants will take approximately 10-20 minutes to complete the CDI. The CDI has been widely used among Thai populations with support for validity and good internal consistency (Alpha Cronbach = 0.82, Reangsing, 2011)
the Psychological Well-Being Scale-Thai-version
Time frame: up to 8 weeks
PWB-S, is developed by Ryff (1989) and back-translation by Klainin-Yobas et al. (2020). The scale is comprised of 18 items with 6 subscales including autonomy, environmental mastery, purpose of life, personal growth, positive relations with other, and self-acceptance. Participants will rate themselves based on how they feel and perception, which each item ranging from (1) strongly disagree to (6) strongly agree. Possible scores are range from 18 to 108, with higher scores indicating psychological well-being. This scale has support for validity and acceptant reliability (Alpha Cronbach=.70-.85, Klainin-Yobas et al., 2020)
the Five-Facets Mindfulness Questionnaires (FFMQ)
Time frame: up to 8 weeks
using the Five-Facets Mindfulness Questionnaires (FFMQ) which is a self-report instrument developed by Baer et al. (2008). This scale consists of 39 items, with 5 sub-domains of mindfulness including observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Participants will rate each statement with a number that best describes themselves as scale from never or very rarely true (1) to very often or always true (5). The total FFMQ can be divided by 39 to get an average score of mindfulness (Baer et al., 2006). Higher score indicates high of mindfulness level. This scale has been used among Thai people with a good reliability (Alpha Cronbach = .93, Rattanaphet et al., 2016)
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
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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, 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 4 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?
the Children's Depression Inventory (CDI)-Thai version (time frame: up to 8 weeks). The study lists 3 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.