StressNCT05882565
A Brief Online Mindfulness Intervention: An RCT Protocol
A study testing A brief (14-day) online mindfulness intervention and Psychoeducation online in people with Stress and Anxiety, run by Ka Yan at 1 site in Indonesia.
Trial summary
University students often experience emotional distress that originates from inside or outside academia, and for which treatment would be welcome. Research has shown that mindfulness can help people to reduce stress, anxiety and depression. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- A brief (14-day) online mindfulness intervention and Psychoeducation online
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 1 siteIndonesia
- Study dates
- 3 Mar 2023to 31 Aug 2025
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being admitted to one of the universities in Indonesia
- Having good eyesight and hearing
- Access to the internet and familiarity in navigating the internet
Who cannot join
- Practicing yoga/ meditation/ mindfulness regularly
- Receiving psychological treatment at the time of study enrolment
- Current alcohol or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Online Mindfulness Intervention for Indonesian Undergraduate Students: A Randomized Controlled Trial Protocol
University students often experience emotional distress that originates from inside or outside academia, and for which treatment would be welcome. Research has shown that mindfulness can help people to reduce stress, anxiety and depression. Furthermore, a thinking style that focuses excessively on negative content (repetitive negative thinking; RNT) has consistently been found to be a mediator of the effects of mindfulness on decreasing stress, anxiety and depression. With this study, we want to 1) investigate the effects of mindfulness on stress, anxiety, depression, and RNT in Indonesian sample of undergraduate students and 2) investigate the mediating role of RNT.
Read the detailed description
Time in university is a generally stressful period of life as a lot of students may face challenges both inside and outside academia. In Indonesia, the majority of undergraduate students (40-80%) reports severe to extremely severe levels of stress, anxiety and depression. Nevertheless, only few young people in Indonesia (< 5%) receive treatment due to the unavailability of mental healthcare facilities and high treatment costs. In addition, Indonesian students tend to not seek help from others when experiencing mental health problems, as sharing personal or family experiences about mental issues is generally perceived as embarrassing. A meta-analytic review concluded that online mindfulness has a large effect on reducing stress, and a small but significant beneficial impact on depression and anxiety. A recent systematic review showed that a brief online mindfulness intervention can offer positive mental health outcomes (i.e., reduction of stress, anxiety and depressive symptoms) for both clinical and non-clinical samples. Repetitive negative thinking (RNT), defined as a thinking style that focuses excessively on negative content, has consistently been found to be a mediator of the effects of mindfulness on stress reduction and the amelioration of anxiety and/or depressive symptoms. First, this study aims to investigate the effects of a brief (14-day) online mindfulness intervention on stress, anxiety, depressive symptoms and repetitive negative thinking (RNT) in an Indonesian sample of undergraduate students. It is hypothesized that participants in the mindfulness training and active control (psychoeducation) conditions will report less stress, anxiety, depressive symptoms and RNT after the intervention compared to the waitlist control condition. The psychoeducation intervention has the same structure and length as the mindfulness training, but the content differs as it does not involve skills training. Hence, psychoeducation can decrease mental health complaints, but, in line with previous studies, it is hypothesized that it will be less effective in reducing stress, anxiety and depressive symptoms than the mindfulness training. Second, this study aims to investigate the mediating role of RNT. That is, we study whether changes in RNT (i.e., a reduction) serve as a potential working mechanism through which mindfulness achieves its effect. It is hypothesized that RNT mediates the effects of mindfulness on stress, anxiety, and depressive symptoms.
- Conditions
- Stress, Anxiety, Depression
- Being tested
- A brief (14-day) online mindfulness intervention, Psychoeducation online
- Keywords
- stress, anxiety, depression, mindfulness, repetitive negative thinking, undergraduate students, Indonesia
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A brief (14-day) online mindfulness interventionBehavioural
The content of the online mindfulness intervention is based on studies by Cavanagh et al. (2013, 2018). There is an approximately 10-minute audio tutorial that participants will listen to daily for 14 days. In the first week, participants will be instructed to apply their learned mindfulness skills to their daily activities. In the second week, they will continue practicing by learning to walk in a mindful manner.
Psychoeducation onlineBehavioural
The online psychoeducation was modified from the study by Harrer et al (2019, 2021).
This intervention consists of 14 audio tutorials about stress for 14 days, each lasting approximately 10 minutes. Additionally, there is a text version of each audio tutorial, which can be accessed by participants after listening to the audio.
| Study group | Role | What they receive |
|---|---|---|
| Mindfuness training group | Experimental | This is a group that will receive mindfulness intervention for 14 days. Participants in this group will also be asked baseline, daily and post questions, as well as follow up questions (3 months after the intervention). During the intervention, they can fill out an optional daily journal. Receives: Behavioral: A brief (14-day) online mindfulness intervention |
| Psychoeducation group | Active comparator | This is a group that will receive psychoeducation intervention for 14 days. Participants in this group will also be asked baseline, daily and post questions, as well as follow up questions (3months after the intervention). During the intervention, they can fill out an optional daily journal. Receives: Behavioral: Psychoeducation online |
| Waitlist control group | No intervention | This is a group that will not receive any training, however, this group will be asked several questions (baseline, daily and post questions, as well as follow up questions (3-months later)). They can also fill out an optional daily journal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
DASS-21will be administered to measure depressive symptoms, anxiety and stress. It consists of 21 items that have to be rated on a four-point Likert scale (0 = 'did not apply to me at all' to 4 = 'applied to me very much or most of the time'.
Measured: 2 weeks-3 months
Secondary outcomes (5)
Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)
Change in state mindfulness will be measured using The FFMQ. It includes 39 items, which have to be rated on five-point Likert scale (1 = 'never or very rarely true' to 5 = 'very often or always true'). It includes five components : observing, describing, nonjudging, non reactivity, and acting with awareness.
Measured: 2 weeks-3 months
Perseverative Thinking Questionnaire (PTQ)
Changes in RNT will be measured using The PTQ. The questionnaire (Ehring et al., 2011) is distributed for the trait assessment of repetitive negative thinking, which includes 15-items rated on a five-point Likert scale (1 = 'never' to 5 = 'almost always').
Measured: 2 weeks-3 months
Momentary repetitive negative thinking
There are five items to assess momentary repetitive negative thinking. These items inquire about thinking patterns related to feelings, problems, worries, recurring thoughts, and being stuck on certain issues. Each question should be answered using a seven-point Likert scale, with responses ranging from 1 = 'never' to 7 = 'every time'.
Measured: 2 weeks (daily)
Mood questions
To be able to check training adherence and training performance, questions regarding context (i.e., (1) Are you in a quiet room at the moment, (2) Are you sitting in a comfortable position with your feet flat on the floor [for mindfulness training condition only] and company (i.e., (3) Are you surrounded by company?) will be asked. These questions can be answered with a 'yes' or 'no'.
Measured: 2 weeks (daily)
Daily Journal
In order to obtain additional information about participants' experiences, thoughts, feelings or difficulty regarding the intervention, we will ask them to fill out an (optional) daily journal. Participants can write in the journal at the end of the (everyday) training.
Measured: 2 weeks (daily)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start3 Mar 2023
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ka Yan
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University, The Netherlands
- Responsible party
- Sponsor-investigator, Ka Yan, Maranatha Christian University
- Investigators
- Jan Spijker, Professor, Principal investigator, Radboud University, Propersona Institute for Integrated Mental Health CareKa Yan, Master, Study chair, Universitas Kristen Maranatha-Indonesia, Radboud University-The NetherlandsCilia Witteman, Professor, Study chair, Radboud University, The NetherlandsNessa Ikani, Doctor, Study chair, Radboud University, Pro Persona, Tilburg University-The NetherlandsCleoputri Yusainy, Study chair, Brawijaya University-Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882565
- Sponsor's protocol ID
- 7/KEP/II/2021
- Status last verified
- Sep 2025
- First submitted
- 21 May 2023
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Yan K, Ikani N, Yusainy C, Witteman C, Spijker J. A brief online mindfulness intervention: study protocol for Indonesian undergraduate students, a randomized controlled trial. Trials. 2025 May 13;26(1):155. doi: 10.1186/s13063-025-08858-y.
PubMed 40361160
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Online Mindfulness Intervention for Indonesian Undergraduate Students: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT05882565
- Acronym / sponsor ID
- 7/KEP/II/2021
- Conditions
- Stress, Anxiety, Depression
- Keywords
- stress, anxiety, depression, mindfulness, repetitive negative thinking, undergraduate students, Indonesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Ka YanUniversity, hospital or other
- Collaborators
- Radboud University, The Netherlands
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 31 May 2023 (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.
University students often experience emotional distress that originates from inside or outside academia, and for which treatment would be welcome. Research has shown that mindfulness can help people to reduce stress, anxiety and depression. Furthermore, a thinking style that focuses excessively on negative content (repetitive negative thinking; RNT) has consistently been found to be a mediator of the effects of mindfulness on decreasing stress, anxiety and depression. With this study, we want to 1) investigate the effects of mindfulness on stress, anxiety, depression, and RNT in Indonesian sample of undergraduate students and 2) investigate the mediating role of RNT.
Detailed description
Time in university is a generally stressful period of life as a lot of students may face challenges both inside and outside academia. In Indonesia, the majority of undergraduate students (40-80%) reports severe to extremely severe levels of stress, anxiety and depression. Nevertheless, only few young people in Indonesia (< 5%) receive treatment due to the unavailability of mental healthcare facilities and high treatment costs. In addition, Indonesian students tend to not seek help from others when experiencing mental health problems, as sharing personal or family experiences about mental issues is generally perceived as embarrassing. A meta-analytic review concluded that online mindfulness has a large effect on reducing stress, and a small but significant beneficial impact on depression and anxiety. A recent systematic review showed that a brief online mindfulness intervention can offer positive mental health outcomes (i.e., reduction of stress, anxiety and depressive symptoms) for both clinical and non-clinical samples. Repetitive negative thinking (RNT), defined as a thinking style that focuses excessively on negative content, has consistently been found to be a mediator of the effects of mindfulness on stress reduction and the amelioration of anxiety and/or depressive symptoms. First, this study aims to investigate the effects of a brief (14-day) online mindfulness intervention on stress, anxiety, depressive symptoms and repetitive negative thinking (RNT) in an Indonesian sample of undergraduate students. It is hypothesized that participants in the mindfulness training and active control (psychoeducation) conditions will report less stress, anxiety, depressive symptoms and RNT after the intervention compared to the waitlist control condition. The psychoeducation intervention has the same structure and length as the mindfulness training, but the content differs as it does not involve skills training. Hence, psychoeducation can decrease mental health complaints, but, in line with previous studies, it is hypothesized that it will be less effective in reducing stress, anxiety and depressive symptoms than the mindfulness training. Second, this study aims to investigate the mediating role of RNT. That is, we study whether changes in RNT (i.e., a reduction) serve as a potential working mechanism through which mindfulness achieves its effect. It is hypothesized that RNT mediates the effects of mindfulness on stress, anxiety, and depressive symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfuness training group | Experimental | Behavioral: A brief (14-day) online mindfulness interventionThis is a group that will receive mindfulness intervention for 14 days. Participants in this group will also be asked baseline, daily and post questions, as well as follow up questions (3 months after the intervention). During the intervention, they can fill out an optional daily journal. |
| Psychoeducation group | Active comparator | Behavioral: Psychoeducation onlineThis is a group that will receive psychoeducation intervention for 14 days. Participants in this group will also be asked baseline, daily and post questions, as well as follow up questions (3months after the intervention). During the intervention, they can fill out an optional daily journal. |
| Waitlist control group | No intervention | –This is a group that will not receive any training, however, this group will be asked several questions (baseline, daily and post questions, as well as follow up questions (3-months later)). They can also fill out an optional daily journal. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Being admitted to one of the universities in Indonesia
- Having good eyesight and hearing
- Access to the internet and familiarity in navigating the internet
Key exclusion criteria (3 listed)
- Practicing yoga/ meditation/ mindfulness regularly
- Receiving psychological treatment at the time of study enrolment
- Current alcohol or drug abuse
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 |
|---|---|---|
| A brief (14-day) online mindfulness interventionThe content of the online mindfulness intervention is based on studies by Cavanagh et al. (2013, 2018). There is an approximately 10-minute audio tutorial that participants will listen to daily for 14 days. In the first week, participants will be instructed to apply their learned mindfulness skills to their daily activities. In the second week, they will continue practicing by learning to walk in a mindful manner. | Behavioural | Mindfuness training group |
| Psychoeducation onlineThe online psychoeducation was modified from the study by Harrer et al (2019, 2021). This intervention consists of 14 audio tutorials about stress for 14 days, each lasting approximately 10 minutes. Additionally, there is a text version of each audio tutorial, which can be accessed by participants after listening to the audio. | Behavioural | Psychoeducation group |
Primary outcome
Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Time frame: 2 weeks-3 months
DASS-21will be administered to measure depressive symptoms, anxiety and stress. It consists of 21 items that have to be rated on a four-point Likert scale (0 = 'did not apply to me at all' to 4 = 'applied to me very much or most of the time'.
5 secondary outcomes
Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)
Time frame: 2 weeks-3 months
Perseverative Thinking Questionnaire (PTQ)
Time frame: 2 weeks-3 months
Momentary repetitive negative thinking
Time frame: 2 weeks (daily)
Mood questions
Time frame: 2 weeks (daily)
Daily Journal
Time frame: 2 weeks (daily)
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 24 Sep 2025.
- Derived from this study: PubMed 40361160Yan K, Ikani N, Yusainy C, Witteman C, Spijker J. A brief online mindfulness intervention: study protocol for Indonesian undergraduate students, a randomized controlled trial. Trials. 2025 May 13;26(1):155. doi: 10.1186/s13063-025-08858-y.
- Individual participant dataSharing planned: Yes
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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.
Jan Spijker, Professor principal investigator
Radboud University, Propersona Institute for Integrated Mental Health Care
Ka Yan, Master study chair
Universitas Kristen Maranatha-Indonesia, Radboud University-The Netherlands
Cilia Witteman, Professor study chair
Radboud University, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A brief (14-day) online mindfulness intervention and Psychoeducation online in people with Stress and Anxiety, run by Ka Yan at 1 site in Indonesia.
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 3 inclusion and 3 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 24 Sep 2025. 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 Indonesia. 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?
Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995) (time frame: 2 weeks-3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05882565, which also lists 1 linked publication.
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 24 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.