A Brief Online Mindfulness Intervention: An RCT Protocol

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882565
• Other study ID #: 7/KEP/II/2021
• Status: Recruiting
• Phase: N/A
• Start date: March 3, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Maranatha Christian University
• Contact: Ka Yan, Master
• Phone: 6281802270981
• Email: tjie.kayan[@]ru.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Indonesia	Universitas Kristen Maranatha	Bandung	West Java

Sponsors (2)

Lead Sponsor	Collaborator
Ka Yan	Radboud University, The Netherlands

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)	Change in state mindfulness will be measured using The FFMQ. It includes 39 items, which have to be rated on five-point Likert scale (1 = 'never or very rarely true' to 5 = 'very often or always true'). It includes five components : observing, describing, nonjudging, non reactivity, and acting with awareness.	2 weeks-3 months
Secondary	Perseverative Thinking Questionnaire (PTQ)	Changes in RNT will be measured using The PTQ. The questionnaire (Ehring et al., 2011) is distributed for the trait assessment of repetitive negative thinking, which includes 15-items rated on a five-point Likert scale (1 = 'never' to 5 = 'almost always').	2 weeks-3 months
Secondary	Momentary repetitive negative thinking	There are five items to assess momentary repetitive negative thinking. These items inquire about thinking patterns related to feelings, problems, worries, recurring thoughts, and being stuck on certain issues. Each question should be answered using a seven-point Likert scale, with responses ranging from 1 = 'never' to 7 = 'every time'.	2 weeks (daily)
Secondary	Mood questions	To be able to check training adherence and training performance, questions regarding context (i.e., (1) Are you in a quiet room at the moment, (2) Are you sitting in a comfortable position with your feet flat on the floor [for mindfulness training condition only] and company (i.e., (3) Are you surrounded by company?) will be asked. These questions can be answered with a 'yes' or 'no'.	2 weeks (daily)
Secondary	Daily Journal	In order to obtain additional information about participants' experiences, thoughts, feelings or difficulty regarding the intervention, we will ask them to fill out an (optional) daily journal. Participants can write in the journal at the end of the (everyday) training.	2 weeks (daily)