A Brief Online Mindfulness Intervention: An RCT Protocol

NCT05882565 | Completed

• 1 other identifier: 7/KEP/II/2021
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stress; Anxiety; Depression

Keywords

stress; anxiety; depression; mindfulness; repetitive negative thinking; undergraduate students; Indonesia

Outcome Measures

Primary Outcomes (1)

• 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'.

  2 weeks-3 months

Secondary Outcomes (5)

• Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)

  2 weeks-3 months

• Perseverative Thinking Questionnaire (PTQ)

  2 weeks-3 months

• Momentary repetitive negative thinking

  2 weeks (daily)

• Mood questions

  2 weeks (daily)

• Daily Journal

  2 weeks (daily)

Study Arms (3)

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.

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.

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.

Interventions

A brief (14-day) online mindfulness intervention 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.

Mindfuness training group

Psychoeducation online 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.

Psychoeducation group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ka Yan: lead
• Radboud University, The Netherlands: collaborator

Study Sites (1)

Universitas Kristen Maranatha

Bandung, West Java, 40164, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 40361160 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Jan Spijker, Professor

  Radboud University, Propersona Institute for Integrated Mental Health Care

  PRINCIPAL INVESTIGATOR

• Ka Yan, Master

  Universitas Kristen Maranatha-Indonesia, Radboud University-The Netherlands

  STUDY CHAIR

• Cilia Witteman, Professor

  Radboud University, The Netherlands

  STUDY CHAIR

• Nessa Ikani, Doctor

  Radboud University, Pro Persona, Tilburg University-The Netherlands

  STUDY CHAIR

• Cleoputri Yusainy

  Brawijaya University-Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer at Universitas Kristen Maranatha

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: May 31, 2023
• Study Start: March 3, 2023
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication of the manuscript

Locations

ID (1)