Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001411831
Ethics application status
Approved
Date submitted
2/09/2021
Date registered
20/10/2021
Date last updated
16/12/2022
Date data sharing statement initially provided
20/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot trial of a culturally-attuned internet-delivered mindfulness intervention for psychological distress among Indonesian university students
Scientific title
Pilot trial of a guided culturally-attuned internet-delivered mindfulness intervention for alleviating psychological distress among Indonesian university students
Secondary ID [1] 305122 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 323351 0
Condition category
Condition code
Mental Health 320920 320920 0 0
Anxiety
Mental Health 320921 320921 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study has one intervention arm:
Internet-delivered mindfulness program for Indonesian University students.
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 files of online mindfulness exercises. The audio exercises last 3-5 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 calls, lasting up to 10 minutes from a lay-counsellor. The phone calls will provide support, guidance, and encouragement to login and do the lessons.

Adherence to the intervention will be measured by accessing program analytics, including module completion and self-reported questionnaires to evaluate engagement with mindfulness (e.g. weekly time spent practicing mindfulness).
Intervention code [1] 321526 0
Behaviour
Intervention code [2] 321527 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328709 0
Self-reported psychological distress as measured by Depression Anxiety and Stress Scale - 21 item version(DASS-21)
Timepoint [1] 328709 0
Baseline and post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [1] 400057 0
Self-reported psychological wellbeing as measured by Indonesian Wellbeing Scale.
Timepoint [1] 400057 0
Baseline and Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [2] 400058 0
Self-reported mindfulness as measured by the • Five Facet Mindfulness Questionnaire (FFMQ).
Timepoint [2] 400058 0
Baseline and Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [3] 400059 0
Self-reported psychological distress as measured by the Kessler-10 scale.
Timepoint [3] 400059 0
Baseline and Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [4] 400060 0
Adherence to the program as measured by the number of lessons completed, based on study records.
Timepoint [4] 400060 0
Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [5] 400061 0
Satisfaction, as measured by the Client Satisfaction Questionnaire for Internet Interventions (CSQ-I)
Timepoint [5] 400061 0
Post-intervention: 4 weeks after the intervention commencement.
Secondary outcome [6] 400062 0
Lesson engagement, as measured by study specific self-report questionnaires asking time spent reading the lesson and practicing mindfulness.
Timepoint [6] 400062 0
At each lesson.
Secondary outcome [7] 400063 0
Self-reported expectations of benefit as measured by the Credibility and Expectancy Questionnaire.
Timepoint [7] 400063 0
Baseline
Secondary outcome [8] 402025 0
Module content evaluation related to relevance, easiness, usefulness, comprehensibility, and pleasantness, measured by self-report questionnaire
Timepoint [8] 402025 0
Post intervention: 4 week after commencement of intervention

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
• Current 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), and/or 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/11/2021
Actual
24/11/2021
Date of last participant enrolment
Anticipated
29/11/2021
Actual
2/12/2021
Date of last data collection
Anticipated
28/12/2021
Actual
14/01/2022
Sample size
Target
30
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24056 0
Indonesia
State/province [1] 24056 0

Funding & Sponsors
Funding source category [1] 309512 0
Other
Name [1] 309512 0
LPDP (Lembaga Pengelola Dana Pendidikan) - Indonesian Endowment Fund for Education Institution
Country [1] 309512 0
Indonesia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney
Chancellery UNSW
High Street Kensington NSW 2033
Country
Australia
Secondary sponsor category [1] 310587 0
University
Name [1] 310587 0
Universitas YARSI
Address [1] 310587 0
Jalan Letnan Jendral Suprapto DKI Jakarta, Jakarta Pusat 10510
Country [1] 310587 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309296 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 309296 0
Ethics committee country [1] 309296 0
Australia
Date submitted for ethics approval [1] 309296 0
26/11/2020
Approval date [1] 309296 0
11/03/2021
Ethics approval number [1] 309296 0
HC210006

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

Contacts
Principal investigator
Name 113670 0
A/Prof Jill Newby
Address 113670 0
Black Dog Institute & UNSW Sydney Hospital Road Randwick NSW 2031
Country 113670 0
Australia
Phone 113670 0
+61 2 9065 9099
Fax 113670 0
Email 113670 0
[email protected]
Contact person for public queries
Name 113671 0
Jill Newby
Address 113671 0
Black Dog Institute & UNSW Sydney Hospital Road Randwick NSW 2031
Country 113671 0
Australia
Phone 113671 0
+61 2 9065 9099
Fax 113671 0
Email 113671 0
[email protected]
Contact person for scientific queries
Name 113672 0
Jill Newby
Address 113672 0
Black Dog Institute & UNSW Sydney Hospital Road Randwick NSW 2031
Country 113672 0
Australia
Phone 113672 0
+61 2 9065 9099
Fax 113672 0
Email 113672 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal, following approval on a case-by-case basis,at the discretion of the Study Publications Committee

Conditions for requesting access:
• -

What individual participant data might 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

What types of analyses could be done with individual participant data?
• Only to achieve the aims of approved research proposals

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access is subject to approval by the Study Publications Committee, via the CIA by [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12966Informed consent form  [email protected]
12967Ethical 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.