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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
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Scientific title
An Integrative Adapt Therapy (IAT) for Common Mental Health Symptoms and Resilience amongst Chin, Kachin, Rohingya Refugees living in Malaysia
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Secondary ID [1]
290864
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None
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Universal Trial Number (UTN)
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Trial acronym
IAT vs CBT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
301560
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Anxiety
304962
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Post Traumatic Stress Disorder
304963
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Complicated Grief
304964
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Adaptive Stress Index (ASI)
304966
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Condition category
Condition code
Mental Health
301273
301273
0
0
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Depression
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Mental Health
304164
304164
0
0
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Anxiety
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Mental Health
304165
304165
0
0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
296811
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Treatment: Other
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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).
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Control group
Active
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Outcomes
Primary outcome [1]
300686
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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)
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Assessment method [1]
300686
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Timepoint [1]
300686
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All primary and secondary outcomes will be assessed at baseline, six-week post-treatment, and 12-month post-treatment.
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Primary outcome [2]
303605
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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).
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Assessment method [2]
303605
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Timepoint [2]
303605
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This outcome will now be assessed at 6-week and 12-month posttreatment.
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Secondary outcome [1]
330605
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Functionality: will be assessed using the abbreviated version of the World Health Organization Disability Assessment Schedule (WHO-DAS) (Ustun et al.,2010)
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Assessment method [1]
330605
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Timepoint [1]
330605
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This outcome will now be assessed at 6-week and 12-month posttreatment.
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Secondary outcome [2]
335008
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Attachment styles will be assessed using Close Relationship Scale (Wei, Russell, Mallinckrodt, & Vogel, 2007).
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Assessment method [2]
335008
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Timepoint [2]
335008
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This outcome will now be assessed at 6-week and 12-month posttreatment.
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Secondary outcome [3]
335009
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Sense of injustice will be assessed using a brief index of moral injury (Nash et al., 2013).
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Assessment method [3]
335009
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Timepoint [3]
335009
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This outcome will now be assessed at 6-week and 12-month posttreatment.
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Secondary outcome [4]
335010
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Anticipatory traumatic stress will be assessed using a brief index drawing on our previous research in Timor-Leste. (Tay, Rees, Chen, Kareth, Silove, 2015)
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Assessment method [4]
335010
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Timepoint [4]
335010
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This outcome will now be assessed at 6-week and 12-month posttreatment.
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Secondary outcome [5]
380388
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Generalized Anxiety Disorder will be assessed using the relevant module of the Refugee Mental Health Assessment Package.
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Assessment method [5]
380388
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Timepoint [5]
380388
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GAD will be assessed at baseline, six-week posttreatment, and 12-month posttreatment. This change made prior to recruitment.
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Secondary outcome [6]
380389
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Persistent Complex Bereavement Disorder will be assessed using the relevant module of the Refugee Mental Health Assessment Package.
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Assessment method [6]
380389
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Timepoint [6]
380389
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PCBD will be assessed at baseline, 6-week posttreatment, and 12-month posttreatment.
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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).
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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
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.
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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)
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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
23/10/2017
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Actual
30/10/2017
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Date of last participant enrolment
Anticipated
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Actual
30/06/2018
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Date of last data collection
Anticipated
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Actual
31/08/2019
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Sample size
Target
300
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Accrual to date
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Final
331
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Recruitment outside Australia
Country [1]
8555
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Malaysia
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State/province [1]
8555
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
295294
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Government body
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Name [1]
295294
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NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL PROGRAM GRANT
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Address [1]
295294
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GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601, Australia
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Country [1]
295294
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Australia
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Primary sponsor type
University
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Name
UNIVERSITY OF NEW SOUTH WALES
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Address
PSYCHIATRY RESEARCH AND TEACHING UNIT
LIVERPOOL HOSPITAL
SCHOOL OF PSYCHIATRY
UNIVERSITY OF NEW SOUTH WALES
SYDNEY, AUSTRALIA
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Country
Australia
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Secondary sponsor category [1]
296601
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None
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Name [1]
296601
0
n/a
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Address [1]
296601
0
n/a
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Country [1]
296601
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
296666
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Perdana University-Institutional Review Board
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Ethics committee address [1]
296666
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Perdana University, Block B and D1, MAEPS Building, MARDI Complex, Jalan MAEPS Perdana, 43400 Serdang, Selangor, Malaysia.
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Ethics committee country [1]
296666
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Malaysia
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Date submitted for ethics approval [1]
296666
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01/06/2017
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Approval date [1]
296666
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04/08/2017
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Ethics approval number [1]
296666
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PU IRBHR00132
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Ethics committee name [2]
298679
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University of New South Wales Human Research Ethnics
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Ethics committee address [2]
298679
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UNSW Research Ethics & Compliance Support. The University of New South Wales. Sydney NSW 2052 Australia
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Ethics committee country [2]
298679
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Australia
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Date submitted for ethics approval [2]
298679
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27/09/2017
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Approval date [2]
298679
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Ethics approval number [2]
298679
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Summary
Brief summary
Promoting the mental health and psychosocial wellbeing of refugees is a global public health priority. Yet questions remain about the cultural and contextual relevance and effectiveness of psychotherapies applied for specific mental health problems encountered amongst this population. First, the range of mental health problems is wide encompassing co-morbid disorders and forms of distress, yet most interventions focus on the limited outcome of post-traumatic stress disorder (PTSD). Second, western derived methods of intervention draw heavily on cognitive behavioural techniques which on their own may be culturally and contextually alien and more broadly, are not directly congruent with the experiences of refugees. Third, recruitment to studies rarely reflects a systematic approach to identifying persons in need in the community. Finally, interventions tend to be focused on psychopathology (symptoms of distress) rather than on building the capacity for positive adaptation based on an understanding of the psychosocial disruptions that refugees continue to confront following exposure to conflict and displacement. This RCT intervention is innovative in allowing all eligible refugees from a defined catchment area to participate and on focusing specifically on building adaptive capacity based on an established psychosocial model (ADAPT) amongst Burmese refugees (members of the Chin, Kachin, and Rohingya communities) in Malaysia. Specifically, the study will test the efficacy of Integrated ADAPT therapy (IAT), a novel approach that is grounded in the refugee experience rather than on a set of "imported" cognitive behavioural techniques applied to treat traumatic stress in western settings. Our team has spent the past two years in intensive engagement with the communities and relevant stakeholders, using extensive community consultation to ensure the feasibility, acceptability and safety of the project, as well as its contextual and cultural relevance. We have built a strong consensus amongst all stakeholders concerning the value and acceptability of the project. The procedure has has been fully manualized, and preliminary training of potential therapists has been very well received. The comparison group will receive CBT as outlined hereunder. Integral to the study is a process for immediate translation and dissemination based on a policy and practice protocol (TPPP), a process that will be greatly facilitated by the extensive engagement, consultation and interaction process that has taken place over the preceding two years with all stakeholders relevant to the communities in which the study will be implemented
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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
65726
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Dr Alvin Tay
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Address
65726
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Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
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Country
65726
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Australia
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Phone
65726
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+61295974114
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Fax
65726
0
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Email
65726
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[email protected]
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Contact person for public queries
Name
65727
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Alvin Tay
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Address
65727
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Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
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Country
65727
0
Australia
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Phone
65727
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+61430036041
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Fax
65727
0
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Email
65727
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[email protected]
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Contact person for scientific queries
Name
65728
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Alvin Tay
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Address
65728
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Level 1 Mental Health Center,
Liverpool Hospital,
Locked Bag 7103
LIVERPOOL BC NSW 1871
Australia.
School of Psychiatry
UNSW
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Country
65728
0
Australia
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Phone
65728
0
+61430036041
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Fax
65728
0
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Email
65728
0
[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?
The de-identified data underlying the specific results in a published article be made available, without restrictions on access, in a public repository.
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When will data be available (start and end dates)?
The data will be available from Jan 2020 to Dec 2020
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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.
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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.
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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
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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
Source
Title
Year of Publication
DOI
Embase
An Integrative Adapt Therapy for common mental health symptoms and adaptive stress amongst Rohingya, Chin, and Kachin refugees living in Malaysia: A randomized controlled trial.
2020
https://dx.doi.org/10.1371/JOURNAL.PMED.1003073
N.B. These documents automatically identified may not have been verified by the study sponsor.
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