A Brief Online Mindfulness Intervention: An RCT Protocol

Ka Yan

Status: Completed

Conditions: Depression; Anxiety; Stress

Treatments: Behavioral: A brief (14-day) online mindfulness intervention; Behavioral: Psychoeducation online

Study type: Interventional

Funder types: Other

Identifiers

NCT05882565

7/KEP/II/2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 426 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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426 participants in 3 patient groups

Mindfuness training group

Experimental group

Description:

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.

Treatment:

Behavioral: A brief (14-day) online mindfulness intervention

Psychoeducation group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychoeducation online

Waitlist control group

No Intervention group

Description:

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.