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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
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.
Scientific title
Randomized controlled trial of a guided culturally attuned internet-delivered mindfulness intervention for treating psychological distress among Indonesian university students.
Secondary ID [1] 307089 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This study is follow-up from pilot study with registration record ACTRN12621001411831.

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 326249 0
Condition category
Condition code
Mental Health 323551 323551 0 0
Depression
Mental Health 323552 323552 0 0
Anxiety

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 323543 0
Behaviour
Intervention code [2] 323579 0
Treatment: Other
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).
Control group
Active

Outcomes
Primary outcome [1] 331309 0
Self-reported psychological distress as measured by Depression Anxiety and Stress Scale - 21 item version(DASS-21)
Timepoint [1] 331309 0
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,
Secondary outcome [1] 409491 0
Self-reported psychological wellbeing as measured by Indonesian Wellbeing Scale
Timepoint [1] 409491 0
Baseline, post-intervention: 4 weeks after the intervention commencement, then follow up: 1 month after the end of intervention,
Secondary outcome [2] 409492 0
Self-reported mindfulness as measured by the • Five Facet Mindfulness Questionnaire (FFMQ).
Timepoint [2] 409492 0
Baseline, post-intervention: 4 weeks after the intervention commencement, then follow up: 1 month after the end of intervention,
Secondary outcome [3] 409493 0
Adherence to the program as measured by the number of lessons completed, based on study records.
Timepoint [3] 409493 0
Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [4] 409494 0
Satisfaction, as measured by the Client Satisfaction Questionnaire for Internet Interventions (CSQ-I)
Timepoint [4] 409494 0
Post-intervention: 4 weeks after the intervention commencement
Secondary outcome [5] 409495 0
Lesson engagement, as measured by study specific self-report questionnaires asking time spent practicing mindfulness.
Timepoint [5] 409495 0
At each lesson.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/08/2022
Actual
20/09/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
28/10/2022
Date of last data collection
Anticipated
30/11/2022
Actual
18/01/2023
Sample size
Target
100
Accrual to date
Final
156
Recruitment outside Australia
Country [1] 24757 0
Indonesia
State/province [1] 24757 0

Funding & Sponsors
Funding source category [1] 311397 0
Government body
Name [1] 311397 0
LPDP (Lembaga Pengelola Dana Pendidikan) - Indonesian Endowment Fund for Education Institution
Country [1] 311397 0
Indonesia
Funding source category [2] 311423 0
Other
Name [2] 311423 0
Black Dog Institute
Country [2] 311423 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney
Chancellery UNSW
High Street Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 312787 0
University
Name [1] 312787 0
YARSI University
Address [1] 312787 0
Jalan Letnan Jendral Suprapto
DKI Jakarta, Jakarta Pusat
10510
Country [1] 312787 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310879 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 310879 0
Ethics committee country [1] 310879 0
Australia
Date submitted for ethics approval [1] 310879 0
26/11/2020
Approval date [1] 310879 0
11/03/2021
Ethics approval number [1] 310879 0
HC210006

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119202 0
A/Prof Jill Newby
Address 119202 0
Black Dog Institute & UNSW Sydney
Hospital Road Randwick NSW 2031
Country 119202 0
Australia
Phone 119202 0
+61 2 9065 9099
Fax 119202 0
Email 119202 0
j.newby@unsw.edu.au
Contact person for public queries
Name 119203 0
Ratih Arruum Listiyandini
Address 119203 0
School of Psychology
Mathews Building
Entry Via Gate 11 Botany Street Randwick
UNSW Sydney NSW 2052
Country 119203 0
Australia
Phone 119203 0
+61 450458930
Fax 119203 0
Email 119203 0
r.listiyandini@unsw.edu.au
Contact person for scientific queries
Name 119204 0
Ratih Arruum Listiyandini
Address 119204 0
School of Psychology
Mathews Building
Entry Via Gate 11 Botany Street Randwick
UNSW Sydney NSW 2052
Country 119204 0
Australia
Phone 119204 0
+61 450458930
Fax 119204 0
Email 119204 0
r.listiyandini@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Immediately following publication, no end date
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
Available for what types of analyses?
Only to achieve the aims of approved research proposals
How or where can data be obtained?
Access is subject to approval by the Study Publications Committee, via the CIA by j.newby@unsw.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15978Informed consent form  j.newby@unsw.edu.au
15979Ethical approval  j.newby@unsw.edu.au



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.