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Trial registered on ANZCTR
Registration number
ACTRN12622000729729
Ethics application status
Approved
Date submitted
13/05/2022
Date registered
20/05/2022
Date last updated
10/12/2023
Date data sharing statement initially provided
20/05/2022
Date results information initially provided
10/12/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Effectiveness of a guided culturally attuned internet-delivered mindfulness intervention for Indonesian university student's distress.
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Scientific title
Randomized controlled trial of a guided culturally attuned internet-delivered mindfulness intervention for treating psychological distress among Indonesian university students.
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Secondary ID [1]
307089
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
This study is follow-up from pilot study with registration record ACTRN12621001411831.
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Health condition
Health condition(s) or problem(s) studied:
Psychological distress
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Condition category
Condition code
Mental Health
323551
323551
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0
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Depression
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Mental Health
323552
323552
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consists of 4 online modules, over a 4 week intervention period. Participants access one online module each week. The intervention is self-administered, and is accessed via the online platform RedCap, and is delivered in Indonesian.
Each online module takes approximately 15 minutes to read/listen to. It comprises a comic-based illustrated story and audio story about a character who is experiencing psychological distress, and learns about how to practice mindfulness to improve their emotional wellbeing. The comic-based illustrations have brief written text to explain about mindfulness, with an audio narration in Indonesian to explain key concepts.
After each module, the participant downloads a PDF (1-3 pages) summarising the content of the online module, and will access audio and some video files of online mindfulness exercises. The audio exercises last 3-15 minutes each, and there are a total of 8 mindfulness audio exercises within the program. The approximate time commitment for participants is 30 minutes total per week.
All participants will be provided weekly contact by phone, email, or text messages based on their preference, lasting up to 10 minutes from a trained counselor. The contact will provide support, guidance, and encouragement to login and do the lessons.
Adherence to the intervention will be measured by module completion and self-reported questionnaires to evaluate engagement with mindfulness (e.g. weekly time spent practicing mindfulness). There would be measurement in baseline (T1), post-treatment (T2), and one month follow up (T3) to measure the outcome.
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Intervention code [1]
323543
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Behaviour
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Intervention code [2]
323579
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Treatment: Other
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Comparator / control treatment
Waiting list control group:
There would be participants that is assigned to the wait list control condition. They will be given access to the intervention after 8 weeks from enrollment and after they completed measurement in week 8. They are allowed to access any other psychological treatment if they need during waiting period, but will be asked to report any counseling or medication that they get during this waiting period. Participants will be asked to complete questionnaires at three time points during this waiting period (baseline, 4 weeks post baseline, and 8 weeks post baseline).
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Control group
Active
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Outcomes
Primary outcome [1]
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Self-reported psychological distress as measured by Depression Anxiety and Stress Scale - 21 item version(DASS-21)
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Assessment method [1]
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Timepoint [1]
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Baseline, post-intervention (4 weeks after the intervention commencement), then follow up (1 month after the end of intervention), Primary time point is post-intervention,
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Secondary outcome [1]
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Self-reported psychological wellbeing as measured by Indonesian Wellbeing Scale
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Assessment method [1]
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Timepoint [1]
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Baseline, post-intervention: 4 weeks after the intervention commencement, then follow up: 1 month after the end of intervention,
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Secondary outcome [2]
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Self-reported mindfulness as measured by the • Five Facet Mindfulness Questionnaire (FFMQ).
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Assessment method [2]
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Timepoint [2]
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Baseline, post-intervention: 4 weeks after the intervention commencement, then follow up: 1 month after the end of intervention,
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Secondary outcome [3]
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Adherence to the program as measured by the number of lessons completed, based on study records.
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Assessment method [3]
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Timepoint [3]
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Post-intervention: 4 weeks after the intervention commencement.
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Secondary outcome [4]
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Satisfaction, as measured by the Client Satisfaction Questionnaire for Internet Interventions (CSQ-I)
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Assessment method [4]
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Timepoint [4]
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Post-intervention: 4 weeks after the intervention commencement
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Secondary outcome [5]
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Lesson engagement, as measured by study specific self-report questionnaires asking time spent practicing mindfulness.
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Assessment method [5]
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Timepoint [5]
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At each lesson.
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Eligibility
Key inclusion criteria
•Indonesian university students who are studying at university in Indonesia,
* Ability to speak Indonesian language fluently,
* aged 18 years or over.
* experiencing elevated psychological distress, defined as meeting criteria for mild psychological distress and above (minimum cut-off points is 15 on stress subscale, 8 for anxiety subscale, and 10 for depression subscale, based on DASS-21)
* have access to a computer and the internet
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Current self-reported diagnosis of psychosis, substance dependence and/or a bipolar disorder, and PTSD.
• Currently receiving mindfulness-based treatment or under other psychological treatment (counselling or other psychotherapy such as CBT).
• Severe depression (based on the DASS-21 depression subscale scores) with currently suicidal and/or recent deliberate self-harm (as determined by risk assessment during the telephone interview).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization completed using Redcap randomization module after the telephone call conducted at screening by the clinician and participant confirmed to enroll by completing the baseline measurement. The random sequential table uploaded to Redcap have been prepared in advance by an independent research assistant who is blinded from participants using a random number generator (e.g., www.random.org). Participants were informed which condition they have been randomly allocated via email that is directly sent by Redcap automatic email system.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants are randomly allocated to either the intervention group or wait list control using a 1:1 ratio. The randomization sequence have been prepared in advance by an independent research assistant blinded to participant using a random number generator (e.g., www.random.org) then uploaded into Redcap randomization module.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Due to the nature of the treatment, it is not possible for treatment allocation to be concealed from the participants or the researchers. Primary outcome data is based on self-report assessment which protects from experimenter bias.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
All analyses will be undertaken using intention to treat linear mixed model analyses. Relationships between observations at different occasions will be modelled with the appropriate covariance matrix. Planned contrasts will be used to compare changes between pre-treatment and post-treatment, and 1-month follow-up. Planned pairwise comparisons will be used to compare between-groups at post-treatment and follow-up, and effect sizes will be calculated (Hedges g) to measure the size of the between-group difference on primary and secondary outcome measures.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
2/08/2022
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Actual
20/09/2022
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Date of last participant enrolment
Anticipated
30/09/2022
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Actual
28/10/2022
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Date of last data collection
Anticipated
30/11/2022
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Actual
18/01/2023
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Sample size
Target
100
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Accrual to date
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Final
156
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Recruitment outside Australia
Country [1]
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Indonesia
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State/province [1]
24757
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Funding & Sponsors
Funding source category [1]
311397
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Government body
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Name [1]
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LPDP (Lembaga Pengelola Dana Pendidikan) - Indonesian Endowment Fund for Education Institution
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Address [1]
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Gedung Danadyaksa Cikini, Jl. Cikini Raya No.91A-D, Menteng, Jakarta Pusat, Indonesia, 10310
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Country [1]
311397
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Indonesia
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Funding source category [2]
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Other
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Name [2]
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Black Dog Institute
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Address [2]
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Black Dog Institute, Hospital Road, Prince of Wales Hospital, Randwick NSW 2031
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Country [2]
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Australia
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Primary sponsor type
University
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Name
UNSW Sydney
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Address
UNSW Sydney
Chancellery UNSW
High Street Kensington NSW 2033
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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YARSI University
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Address [1]
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Jalan Letnan Jendral Suprapto
DKI Jakarta, Jakarta Pusat
10510
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Country [1]
312787
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Indonesia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310879
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [1]
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UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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26/11/2020
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Approval date [1]
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11/03/2021
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Ethics approval number [1]
310879
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HC210006
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Summary
Brief summary
This project tests the efficacy of a guided culturally-attuned online mindfulness program for Indonesian university students who are experiencing psychological distress compared to waiting list control group. There is strong evidence that online mindfulness programs improve psychological distress and wellbeing in English-speaking participants. However, little research has evaluated online mindfulness interventions in Low or Middle Income Countries. This randomized controlled trial will recruit Indonesian university students. The main aim is to examine the mental health outcomes, participants adherence and engagement with the program, and completion rates. To do this we will recruit up to 100 Indonesian university students to participate, and allocate them into two groups, which is online guided mindfulness intervention group and waiting list control group. It is hypothesized that internet-delivered mindfulness intervention specifically tailored for Indonesian university students will significantly reduce students’ self-reported levels of psychological distress, and it will be significantly more effective than the waitlist control group at reducing students’ self-reported levels of psychological distress.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jill Newby
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Address
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Black Dog Institute & UNSW Sydney
Hospital Road Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9065 9099
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Ratih Arruum Listiyandini
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Address
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School of Psychology
Mathews Building
Entry Via Gate 11 Botany Street Randwick
UNSW Sydney NSW 2052
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Country
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Australia
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Phone
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+61 450458930
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mrs Ratih Arruum Listiyandini
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Address
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School of Psychology
Mathews Building
Entry Via Gate 11 Botany Street Randwick
UNSW Sydney NSW 2052
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Country
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Australia
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Phone
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+61 450458930
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Any individual participant data collected during the trial, after de-identification, is potentially available,pending review of data requests by the Study Publications Committee
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When will data be available (start and end dates)?
Immediately following publication, no end date
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Available to whom?
Researchers who provide a methodologically sound proposal, following approval on a case-by-case basis,at the discretion of the Study Publications Committee
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Available for what types of analyses?
Only to achieve the aims of approved research proposals
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How or where can data be obtained?
Access is subject to approval by the Study Publications Committee, via the CIA by
[email protected]
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15978
Informed consent form
[email protected]
15979
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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