Clinical trial NCT05882565: A Brief Online Mindfulness Intervention: An RCT Protocol
Official title: A Brief Online Mindfulness Intervention for Indonesian Undergraduate Students: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Depression
Keywords: stress
anxiety
depression
mindfulness
repetitive negative thinking
undergraduate students
Indonesia
Lead sponsor: Maranatha Christian University
Sponsor class: OTHER
Collaborators: name: Radboud University, The Netherlands
First posted: 2023-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
timeFrame: 2 weeks-3 months
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)
timeFrame: 2 weeks-3 months
measure: Perseverative Thinking Questionnaire (PTQ)
timeFrame: 2 weeks-3 months
measure: Momentary repetitive negative thinking
timeFrame: 2 weeks (daily)
measure: Mood questions
timeFrame: 2 weeks (daily)
measure: Daily Journal
timeFrame: 2 weeks (daily)
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Universitas Kristen Maranatha
state: West Java
Study officials:
affiliation: Radboud University, Propersona Institute for Integrated Mental Health Care
name: Jan Spijker, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitas Kristen Maranatha-Indonesia, Radboud University-The Netherlands
name: Ka Yan, Master
role: STUDY_CHAIR
affiliation: Radboud University, The Netherlands
name: Cilia Witteman, Professor
role: STUDY_CHAIR
affiliation: Radboud University, Pro Persona, Tilburg University-The Netherlands
name: Nessa Ikani, Doctor
role: STUDY_CHAIR
affiliation: Brawijaya University-Indonesia
name: Cleoputri Yusainy
role: STUDY_CHAIR
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