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Clinical Trials/NCT05882565
NCT05882565
Completed
Not Applicable

A Brief Online Mindfulness Intervention for Indonesian Undergraduate Students: A Randomized Controlled Trial Protocol

Ka Yan1 site in 1 country426 target enrollmentMarch 3, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Ka Yan
Enrollment
426
Locations
1
Primary Endpoint
Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Status
Completed
Last Updated
7 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 3, 2023
End Date
August 31, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ka Yan
Responsible Party
Sponsor Investigator
Principal Investigator

Ka Yan

Lecturer at Universitas Kristen Maranatha

Maranatha Christian University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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'.

Secondary Outcomes

  • Mood questions(2 weeks (daily))
  • Momentary repetitive negative thinking(2 weeks (daily))
  • Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)(2 weeks-3 months)
  • Perseverative Thinking Questionnaire (PTQ)(2 weeks-3 months)
  • Daily Journal(2 weeks (daily))

Study Sites (1)

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