A Brief Online Mindfulness Intervention: An RCT Protocol

NCT ID: NCT05882565

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-03

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Stress Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mindfuness training group

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.

Group Type EXPERIMENTAL

A brief (14-day) online mindfulness intervention

Intervention Type BEHAVIORAL

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 group

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.

Group Type ACTIVE_COMPARATOR

Psychoeducation online

Intervention Type BEHAVIORAL

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.

Waitlist control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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A brief (14-day) online mindfulness intervention

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.

Intervention Type BEHAVIORAL

Psychoeducation online

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Being admitted to one of the universities in Indonesia
* Having good eyesight and hearing
* Access to the internet and familiarity in navigating the internet

Exclusion Criteria

* Practicing yoga/ meditation/ mindfulness regularly
* Receiving psychological treatment at the time of study enrolment
* Current alcohol or drug abuse
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University, The Netherlands

UNKNOWN

Sponsor Role collaborator

Ka Yan

OTHER

Sponsor Role lead

Responsible Party

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Ka Yan

Lecturer at Universitas Kristen Maranatha

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jan Spijker, Professor

Role: PRINCIPAL_INVESTIGATOR

Radboud University, Propersona Institute for Integrated Mental Health Care

Ka Yan, Master

Role: STUDY_CHAIR

Universitas Kristen Maranatha-Indonesia, Radboud University-The Netherlands

Cilia Witteman, Professor

Role: STUDY_CHAIR

Radboud University, The Netherlands

Nessa Ikani, Doctor

Role: STUDY_CHAIR

Radboud University, Pro Persona, Tilburg University-The Netherlands

Cleoputri Yusainy

Role: STUDY_CHAIR

Brawijaya University-Indonesia

Locations

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Universitas Kristen Maranatha

Bandung, West Java, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 40361160 (View on PubMed)

Other Identifiers

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7/KEP/II/2021

Identifier Type: -

Identifier Source: org_study_id

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