Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000609550
Ethics application status
Approved
Date submitted
10/04/2024
Date registered
10/05/2024
Date last updated
6/09/2024
Date data sharing statement initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing a low-intensity mental health intervention for refugees in Indonesia
Scientific title
Evaluating the efficacy of and mechanisms underlying a low-intensity psychological intervention for refugees
Secondary ID [1] 311910 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological Distress 333499 0
Posttraumatic Stress Disorder 333500 0
Condition category
Condition code
Mental Health 330174 330174 0 0
Other mental health disorders
Mental Health 330175 330175 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention used in this trial will be Doing What Matters in Times of Stress (DWM). DWM is a brief, self-help intervention developed by the World Health Organisation (WHO). It is an illustrated guide of an existing intervention called Self-Help Plus (SH+). The DWM manual was released by the WHO in 2020 to support the remote delivery of SH+, considering the COVID-19 pandemic and a growing need for online/remotely delivered interventions. DWM materials used in this trial are readily available from WHO (https://www.who.int/publications/i/item/9789240003927) and have not been altered.

DWM is: based on Acceptance and Commitment Therapy and adapted for many settings; intended as an intervention for managing stress and coping with adversity; relevant for anyone above the age of 18; designed to be completed over a short period of time; practical so that participants can practice skills regularly on their own; and illustrated, with accompanying audio recordings to support regular practice. The manual involves the following empirically supported elements: psychoeducation, grounding, cognitive defusion, mindfulness exercises, values clarification, and compassion exercises.

DWM can be delivered in a variety of formats (e.g., unguided self-paced, guided individual treatment, guided group-based treatment). For the current trial, we are testing the guided individual version of DWM. This means that participants in the active treatment condition will receive:
1. The DWM illustrated workbook that contains five ‘lessons’. The five lesson topics are: Grounding, Unhooking, Acting on Your Values, Being Kind, and Making Room.
2. Accompanying audio files that provide guided scripts for practicing the strategies taught in the workbook. Participant receive a link to the study site where the audio files can be downloaded.
3. Five weekly one-on-one calls (via phone or Zoom) from a trained facilitator, who will help participants to practice the therapeutic techniques. We anticipate these weekly facilitator calls will range from 20-50 minutes. Facilitators are local workers who speak the same language as trial participants and who have experience working with people from refugee backgrounds. Protocol adherence will be ensured by regular clinical supervision of the facilitators and treatment fidelity checks using a checklist. Facilitators will receive at least 28 hours of face-to-face training, at least 1 month prior to the first participant enrolment.

The duration of the study for any participant will conclude after the final post-intervention assessment, resulting in a participation duration of 9 weeks.
Intervention code [1] 328379 0
Behaviour
Intervention code [2] 328380 0
Treatment: Other
Comparator / control treatment
The comparator condition will be a waitlist control group (WLC). The duration of the study for any participant will conclude after the final post-intervention assessment, resulting in a participation duration of 9 weeks. Participants in the WLC will gain access to the unguided version of DWM (i.e., the DWM workbook and audio files, but no facilitators calls) upon completion of their final assessment at the end of the 9-week waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 337931 0
Psychological distress
Timepoint [1] 337931 0
Pre-treatment (including as a screening measure; week 0), mid-treatment (week 3), post-treatment (week 6; primary timepoint), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [1] 433775 0
Posttraumatic stress symptoms
Timepoint [1] 433775 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [2] 433776 0
Suicidal ideation
Timepoint [2] 433776 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [3] 433777 0
Self-identified problems
Timepoint [3] 433777 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [4] 433778 0
Wellbeing and quality of life
Timepoint [4] 433778 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [5] 433779 0
Functional impairment
Timepoint [5] 433779 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [6] 433780 0
Digital markers of positive and negative affect and arousal
Timepoint [6] 433780 0
Pre-treatment (week 0), post-treatment (week 6).
Secondary outcome [7] 433781 0
(Exploratory outcome) Psychological flexibility (1)
Timepoint [7] 433781 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [8] 433782 0
(Exploratory outcome) Intolerance of uncertainty
Timepoint [8] 433782 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [9] 433783 0
(Exploratory outcome) Social functioning (1)
Timepoint [9] 433783 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [10] 433784 0
(Exploratory outcome) Momentary emotional states (e.g., anger, sadness, happiness)
Timepoint [10] 433784 0
7-day EMA block (5 surveys per day) at pre-treatment (week 0) and post-treatment (week 6).
Secondary outcome [11] 433785 0
(Exploratory outcome) Momentary emotion regulation strategy use (e.g., rumination, suppression, reappraisal)
Timepoint [11] 433785 0
7-day EMA block (5 surveys per day) at pre-treatment (week 0) and post-treatment (week 6).
Secondary outcome [12] 433786 0
(Exploratory outcome) Momentary stressors and context (e.g., positive/negative event, location, social contact)
Timepoint [12] 433786 0
7-day EMA block (5 surveys per day) at pre-treatment (week 0) and post-treatment (week 6).
Secondary outcome [13] 439511 0
(Exploratory Outcome) Repetitive Negative Thinking
Timepoint [13] 439511 0
Secondary outcome [14] 439512 0
(Exploratory Outcome) Repetitive Negative Thinking
Timepoint [14] 439512 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [15] 439513 0
(Exploratory outcome) Psychological Flexibility (2)
Timepoint [15] 439513 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [16] 439514 0
(Exploratory outcome) Psychological Flexibility (2)
Timepoint [16] 439514 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [17] 439515 0
(Exploratory outcome) Social functioning (2)
Timepoint [17] 439515 0
Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).
Secondary outcome [18] 439516 0
(Exploratory outcome) Social functioning (2)
Timepoint [18] 439516 0

Pre-treatment (week 0), mid-treatment (week 3), post-treatment (week 6), and follow-up (1 month after the completion of treatment; week 9).

Eligibility
Key inclusion criteria
Inclusion criteria for participants taking part in this study include: (a) 18+ years, (b) from a refugee background, (c) able to speak and read Farsi, and (d) experiencing elevated levels of psychological distress (K10 > 19.9).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study include: (a) participants that do not meet the above inclusion criteria, (b) acute medical conditions, (c) imminent suicide risk or with expressed acute needs/protection risks (e.g., a woman who reports that she is at acute risk of domestic and/or sexual violence), (d) severe mental disorder (psychotic disorders, substance-dependence), (e) severe cognitive impairment (e.g., severe intellectual disability or dementia), and/or (f) concurrent psychological treatment (e.g., currently receiving psychological services from a psychologist, counsellor or mental health-focused program), (g) no access to a smart phone and internet connection.

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)
Following determination of eligibility (i.e., upon completion of pre-treatment assessment), the research coordinator will input the participant ID into a computerised system. The computerised system will reveal the allocation sequence to the project coordinator who will inform the project administrator and project supervisors only. Those conducting the outcome assessments at mid-treatment, post-treatment and 1-month follow-up will remain blind to allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based on a 2:1 allocation ratio, such that double the number of participants will be allocated to active treatment (DWM) compared to the waitlist control condition. Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation using REDcap) will be the method of sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using hierarchical linear modelling or linear mixed models. Both intention-to-treat analysis (ITT; using all randomised participants) and per protocol (PP) analysis will be used.
Primary study parameter: The main conclusion (testing the efficacy of the DWM intervention) will be primarily based on the ITT analysis of the primary outcome. A secondary analysis of the primary outcome will also be presented using the PP population. To estimate the treatment effect, data from all assessments (pre-, mid-, post-treatment and follow-up) will be used. A linear mixed model will be employed for the primary endpoint analysis, to explore linear time effects, treatment conditions, and interactions. 95% confidence intervals and Cohen’s d effect size will be reported. Covariate-adjusted mixed model of primary endpoint will also be performed. The primary outcome measure will be the K10 (Psychological Distress) scores.
Secondary study parameters: A linear mixed model as mentioned for the primary outcome analysis will be carried out for analysing the secondary outcomes (e.g., PTSD, Suicidal Ideation, Self-Identified Problems, Wellbeing, Functional Impairment). Additionally, for analysis of digital markers, advanced machine learning approaches will be used to process and analyse video and acoustic data derived from assessment recordings to test change in functioning from pre- to post-treatment.
We anticipate that these results will be published as the first outcome of this trial. Exploratory analyses, to investigate the mechanisms of change within the DWM intervention, will subsequently be conducted and published as secondary outputs from this trial.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
4/07/2024
Date of last participant enrolment
Anticipated
5/01/2026
Actual
Date of last data collection
Anticipated
6/03/2026
Actual
Sample size
Target
303
Accrual to date
44
Final
Recruitment outside Australia
Country [1] 26242 0
Indonesia
State/province [1] 26242 0

Funding & Sponsors
Funding source category [1] 316258 0
Government body
Name [1] 316258 0
Australian Research Council
Country [1] 316258 0
Australia
Funding source category [2] 316259 0
Charities/Societies/Foundations
Name [2] 316259 0
MQ Mental Health Research
Country [2] 316259 0
United Kingdom
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 318448 0
None
Name [1] 318448 0
Address [1] 318448 0
Country [1] 318448 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315079 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 315079 0
Ethics committee country [1] 315079 0
Australia
Date submitted for ethics approval [1] 315079 0
15/11/2023
Approval date [1] 315079 0
30/01/2024
Ethics approval number [1] 315079 0
iRECS4937

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

Contacts
Principal investigator
Name 133606 0
Prof Angela Nickerson
Address 133606 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 133606 0
Australia
Phone 133606 0
+61 2 9385 0538
Fax 133606 0
Email 133606 0
[email protected]
Contact person for public queries
Name 133607 0
Angela Nickerson
Address 133607 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 133607 0
Australia
Phone 133607 0
+61 2 9385 0538
Fax 133607 0
Email 133607 0
[email protected]
Contact person for scientific queries
Name 133608 0
Angela Nickerson
Address 133608 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 133608 0
Australia
Phone 133608 0
+61 2 9385 0538
Fax 133608 0
Email 133608 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All deidentified baseline data and outcome data will be available.
When will data be available (start and end dates)?
Data will be available after all data collection and analyses have been completed. This will occur after 2026; no end date.
Available to whom?
Any researcher can request the data.
Available for what types of analyses?
IPD meta-analyses.
How or where can data be obtained?
Request to Principal Investigator (Angela Nickerson; [email protected])


What supporting documents are/will be available?

No Supporting Document Provided



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.