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Trial registered on ANZCTR


Registration number
ACTRN12617001452381
Ethics application status
Approved
Date submitted
24/09/2017
Date registered
12/10/2017
Date last updated
21/02/2020
Date data sharing statement initially provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An Integrative Adapt Therapy (IAT) for Common Mental Health Symptoms and Resilience amongst Chin, Kachin, Rohingya Refugees living in Malaysia
Scientific title
An Integrative Adapt Therapy (IAT) for Common Mental Health Symptoms and Resilience amongst Chin, Kachin, Rohingya Refugees living in Malaysia
Secondary ID [1] 290864 0
None
Universal Trial Number (UTN)
Trial acronym
IAT vs CBT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301560 0
Anxiety 304962 0
Post Traumatic Stress Disorder 304963 0
Complicated Grief 304964 0
Adaptive Stress Index (ASI) 304966 0
Condition category
Condition code
Mental Health 301273 301273 0 0
Depression
Mental Health 304164 304164 0 0
Anxiety
Mental Health 304165 304165 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Integrative Adapt Therapy (IAT) program involves six weekly 45-minute sessions. As indicated, IAT is a manualized treatment that is grounded in the five psychosocial pillars of the ADAPT model (Tay et al., 2019). Community counselors will be trained to deliver IAT. Refugees participating in IAT are encouraged to reflect on past and ongoing experiences related to the disruptions of the psychosocial foundations of their societies, their families and their personal lives as they transitioned through the trajectory of mass conflict, upheaval, displacement, flight, and resettlement. Connections are made between these experiences, their meaning to the person, and symptoms and maladaptive behaviours manifest by the person. The strategies offered for dealing with these issues are framed in a manner that ensures their integration within the broader ADAPT framework IAT. These strategies include psychoeducation, trauma narrative/in-vivo exposure, problem-solving, stress management, emotion regulation, cognitive reappraisal, and meaning-making.
Intervention code [1] 296811 0
Treatment: Other
Comparator / control treatment
The Cognitive Behavioral Treatment (CBT) condition involves six weekly 45-minute sessions and included six core treatment strategies: psychoeducation, stress management, problem-solving, behavioural activation, cognitive reappraisal, and strengthening social support based on existing evidence of their effectiveness and their suitability for application by lay counsellors based on the principle of task-shifting.
Each strategy was introduced sequentially over the course of six sessions and each session was designed to build on the previously learned techniques. Participants were given homework practice to enhance their mastery of the skills taught. Although the same techniques were used in both therapies, the major difference was that the overarching ADAPT framework was not included in the CBT arm. Instead, the treatment was presented as an intervention to manage stress and interactions with others. Where appropriate, traumatic events were inculcated in the procedure. For example, in the session focusing on cognitive re-appraisal, a refugee who reported feelings of guilt and shame following sexual assault was taught cognitive re-appraisal techniques to address these maladaptive thoughts and feelings. A fuller account of the distinctive features or IAT compared to other CBT-derived treatments are detailed in our background paper (9, 24).
Control group
Active

Outcomes
Primary outcome [1] 300686 0
Primary outcomes (listed below) will be assessed using the Refugee Mental Health Assessment Package:
1) Post-traumatic Stress Disorder
2) Complex PTSD
3) Major Depressive Disorder
4) Resilience assessing using The Connor-Davidson Resilience Scale (CDRS)
5) Adaptive Stress Index which comprises five subscales - ASI-1 (safety/security), ASI-2 (networks/bonds), ASI-3 (injustice), ASI-4 (roles/identities), ASI-5 (existential meaning)
Timepoint [1] 300686 0
All primary and secondary outcomes will be assessed at baseline, six-week post-treatment, and 12-month post-treatment.
Primary outcome [2] 303605 0
Interpersonal functioning: will be assessed using the Inventory of Interpersonal Problems Short Form, a brief index of individuals’ self-reported difficulties in interpersonal relationships (Barkham, Hardy, & Startup, 1996).
Timepoint [2] 303605 0
This outcome will now be assessed at 6-week and 12-month posttreatment.
Secondary outcome [1] 330605 0
Functionality: will be assessed using the abbreviated version of the World Health Organization Disability Assessment Schedule (WHO-DAS) (Ustun et al.,2010)
Timepoint [1] 330605 0
This outcome will now be assessed at 6-week and 12-month posttreatment.
Secondary outcome [2] 335008 0
Attachment styles will be assessed using Close Relationship Scale (Wei, Russell, Mallinckrodt, & Vogel, 2007).
Timepoint [2] 335008 0
This outcome will now be assessed at 6-week and 12-month posttreatment.
Secondary outcome [3] 335009 0
Sense of injustice will be assessed using a brief index of moral injury (Nash et al., 2013).
Timepoint [3] 335009 0
This outcome will now be assessed at 6-week and 12-month posttreatment.
Secondary outcome [4] 335010 0
Anticipatory traumatic stress will be assessed using a brief index drawing on our previous research in Timor-Leste. (Tay, Rees, Chen, Kareth, Silove, 2015)
Timepoint [4] 335010 0
This outcome will now be assessed at 6-week and 12-month posttreatment.
Secondary outcome [5] 380388 0
Generalized Anxiety Disorder will be assessed using the relevant module of the Refugee Mental Health Assessment Package.
Timepoint [5] 380388 0
GAD will be assessed at baseline, six-week posttreatment, and 12-month posttreatment. This change made prior to recruitment.
Secondary outcome [6] 380389 0
Persistent Complex Bereavement Disorder will be assessed using the relevant module of the Refugee Mental Health Assessment Package.
Timepoint [6] 380389 0
PCBD will be assessed at baseline, 6-week posttreatment, and 12-month posttreatment.

Eligibility
Key inclusion criteria
Inclusion criteria were (a) presence of at least one of the designated common mental disorders (CMDs) that is, current PTSD/CPTSD, MDD, GAD, and PCBD; (b) witnessed or experienced at least one traumatic event related to mass conflict; and (c) endorsed at least one ADAPT-related stressor on each scale of the relevant measure (see hereunder).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were age lower than 18 years, overt evidence of intellectual disability, and the presence of overt cognitive impairment or psychosis (as assessed using the WHO mhGAP protocol.

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)
Computer algorithms will be used to generate a sequence of random numbers in order to assign participants to either treatment or control group. A research coordinator will put the random number in a sealed envelope given to each intervention provider prior to the commencement of the intervention. Pre and post-treatment assessments will be conducted by a research assistant independent of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer algorithms will be used to generate a sequence of random numbers in order to assign participants to either treatment or control group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will apply an intention to treat analysis in modelling treatment effects over time based on within-person change in primary (PTSD, CPTSD, MDD, resilience, ASI domains) and secondary (GAD, PCBD) outcomes using mean scores. All variables will be treated as continuous. Initially unadjusted analyses will be conducted to examine pre-post changes in all outcomes within each arm; and differences in baseline and posttreatment scores (at six-week follow-up) between the IAT and CBT arms. For assessing Average Treatment Effects, we will apply a random effects model in which assessment points (0=baseline, 1=follow-up) and counsellor ID were specified as random effects to account for within-person correlation effects across time and between-person correlation effects by counsellor.
Prior to testing the adjusted models, we will use t-Tests for continuous variables and x2 tests for categorical variables to test baseline differences in the sociodemographic variables (sex, ethnicity, marital status, education, employment status) that might confound treatment outcomes as indicated by the literature. For each adjusted model, we will calculate the average treatment effect at follow-up by including the baseline score of each outcome as a covariate. We will report adjusted mean differences at baseline and at six-week follow-up indicating the significance level based on a 2-sided P < .05 value and 95% confidence intervals.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/10/2017
Actual
30/10/2017
Date of last participant enrolment
Anticipated
Actual
30/06/2018
Date of last data collection
Anticipated
Actual
31/08/2019
Sample size
Target
300
Accrual to date
Final
331
Recruitment outside Australia
Country [1] 8555 0
Malaysia
State/province [1] 8555 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 295294 0
Government body
Name [1] 295294 0
NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL PROGRAM GRANT
Country [1] 295294 0
Australia
Primary sponsor type
University
Name
UNIVERSITY OF NEW SOUTH WALES
Address
PSYCHIATRY RESEARCH AND TEACHING UNIT
LIVERPOOL HOSPITAL
SCHOOL OF PSYCHIATRY
UNIVERSITY OF NEW SOUTH WALES
SYDNEY, AUSTRALIA
Country
Australia
Secondary sponsor category [1] 296601 0
None
Name [1] 296601 0
n/a
Address [1] 296601 0
n/a
Country [1] 296601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296666 0
Perdana University-Institutional Review Board
Ethics committee address [1] 296666 0
Ethics committee country [1] 296666 0
Malaysia
Date submitted for ethics approval [1] 296666 0
01/06/2017
Approval date [1] 296666 0
04/08/2017
Ethics approval number [1] 296666 0
PU IRBHR00132
Ethics committee name [2] 298679 0
University of New South Wales Human Research Ethnics
Ethics committee address [2] 298679 0
Ethics committee country [2] 298679 0
Australia
Date submitted for ethics approval [2] 298679 0
27/09/2017
Approval date [2] 298679 0
Ethics approval number [2] 298679 0

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

Contacts
Principal investigator
Name 65726 0
Dr Alvin Tay
Address 65726 0
Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
Country 65726 0
Australia
Phone 65726 0
+61295974114
Fax 65726 0
Email 65726 0
alvin.tay@unsw.edu.au
Contact person for public queries
Name 65727 0
Alvin Tay
Address 65727 0
Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
Country 65727 0
Australia
Phone 65727 0
+61430036041
Fax 65727 0
Email 65727 0
alvin.tay@unsw.edu.au
Contact person for scientific queries
Name 65728 0
Alvin Tay
Address 65728 0
Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
Country 65728 0
Australia
Phone 65728 0
+61430036041
Fax 65728 0
Email 65728 0
alvin.tay@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?
The de-identified data underlying the specific results in a published article be made available, without restrictions on access, in a public repository.
When will data be available (start and end dates)?
The data will be available from Jan 2020 to Dec 2020
Available to whom?
The de-identified data underlying the specific results in a published article be made available, without restrictions on access, in a public repository.
Available for what types of analyses?
The de-identified data underlying the specific results in a published article be made available, without restrictions on access, in a public repository.
How or where can data be obtained?
The de-identified data underlying the specific results in a published article will be made available, without restrictions on access, in a public repository at a later stage, pending the publication of the RCT paper which is now being revised
Following PLos Med recommendations where the lead paper will be published, we will utilize fairsharing as the public repository for de-identified data: https://fairsharing.org/recommendation/PLOS


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
SourceTitleYear of PublicationDOI
EmbaseAn Integrative Adapt Therapy for common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia: A randomized controlled trial.2020https://dx.doi.org/10.1371/JOURNAL.PMED.1003073
N.B. These documents automatically identified may not have been verified by the study sponsor.