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A Brief Online Mindfulness Intervention: An RCT Protocol

Primary Purpose

Stress, Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
A brief (14-day) online mindfulness intervention
Psychoeducation online
Sponsored by
Ka Yan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring stress, anxiety, depression, mindfulness, repetitive negative thinking, undergraduate students, Indonesia

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Universitas Kristen MaranathaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfuness training group

Psychoeducation group

Waitlist control group

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

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'.

Secondary Outcome Measures

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.
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').
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'.
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'.
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.

Full Information

First Posted
May 21, 2023
Last Updated
August 8, 2023
Sponsor
Ka Yan
Collaborators
Radboud University, The Netherlands
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1. Study Identification

Unique Protocol Identification Number
NCT05882565
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 3, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ka Yan
Collaborators
Radboud University, The Netherlands

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety, Depression
Keywords
stress, anxiety, depression, mindfulness, repetitive negative thinking, undergraduate students, Indonesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfuness training group
Arm Type
Experimental
Arm 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.
Arm Title
Psychoeducation group
Arm Type
Active Comparator
Arm 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.
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
A brief (14-day) online mindfulness intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation online
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression Anxiety Stress Scale-21 (DASS-21; Lovibond & Lovibond, 1995)
Description
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'.
Time Frame
2 weeks-3 months
Secondary Outcome Measure Information:
Title
Five Facet Mindfulness Questionnaire (FFMQ: Baer et al., 2006)
Description
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.
Time Frame
2 weeks-3 months
Title
Perseverative Thinking Questionnaire (PTQ)
Description
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').
Time Frame
2 weeks-3 months
Title
Momentary repetitive negative thinking
Description
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'.
Time Frame
2 weeks (daily)
Title
Mood questions
Description
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'.
Time Frame
2 weeks (daily)
Title
Daily Journal
Description
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.
Time Frame
2 weeks (daily)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ka Yan, Master
Phone
6281802270981
Email
tjie.kayan@ru.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Spijker, Professor
Organizational Affiliation
Radboud University, Propersona Institute for Integrated Mental Health Care
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ka Yan, Master
Organizational Affiliation
Universitas Kristen Maranatha-Indonesia, Radboud University-The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cilia Witteman, Professor
Organizational Affiliation
Radboud University, The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Nessa Ikani, Doctor
Organizational Affiliation
Radboud University, Pro Persona, Tilburg University-The Netherlands
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cleoputri Yusainy
Organizational Affiliation
Brawijaya University-Indonesia
Official's Role
Study Chair
Facility Information:
Facility Name
Universitas Kristen Maranatha
City
Bandung
State/Province
West Java
ZIP/Postal Code
40164
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ka Yan, Master
Phone
6281802270981
Email
tjie.kayan@ru.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
6 months after publication of the manuscript

Learn more about this trial

A Brief Online Mindfulness Intervention: An RCT Protocol

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