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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
12/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of Integrated Adapt Therapy vs Problem Management Plus to strengthen resilience and adaptive capacity and reduce posttraumatic comorbidities in refugees exposed to war-related traumatic events and adversity.
Scientific title
A randomized controlled trial of the effectiveness of Integrated Adapt Therapy vs Problem Management Plus amongst displaced refugees living in Malaysia.
Secondary ID [1] 290864 0
None
Universal Trial Number (UTN)
Trial acronym
IAT vs PM+
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
Explosive anger 304965 0
Adaptive distress 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 proposed project will involve a two-armed, randomized, double-blind RCT with a 2 (treatment conditions) x 4 (assessment points) factorial design, conducted amongst Chin, Kachin, and Rohingyas in Malaysia. Persons of refugee background agreeing to participate will be recruited from the epidemiological study (PUIRBHC0130) at that site and randomly allocated to either Integrated ADAPT Therapy (IAT) or Problem Management Plus (PM+).

Novel studies published by Alvin Tay based on these inquiries (Tay, Rees, Chan, Kareth, & Silove, 2015; Tay, Rees, Chen, Kareth, Lahe, et al., 2015) show that the disruptions of the psychosocial systems underpinning the ADAPT model play an important role in shaping mental health and adaptation outcomes and contribute (in concert with past trauma and adversity) not only to a wide array of comorbid mental disorders (CMDs) but also to difficulties in functioning and capacity to adapt to the new environment. Drawing on established Cognitive Behavioural Therapy (CBT) and problem-solving principles and techniques, IAT is based on the psychosocial domains of the ADAPT model (safety/security, bonds/networks, access to justice, roles/identities, and existential meaning) and designed to be grounded in the culture and context of displacement of individual refugee groups given their appropriateness, ease-of-delivery, flexibility, and effectiveness.

A manualized protocol of IAT developed by Dr Tay will be adapted to the history, culture, language, terminology, context of each refugee group. The manual describes in detail the rationale underlying IAT, the steps involved in applying IAT, the use of psychotherapeutic approaches in addressing adaptive issues faced by refugees, clinical vignettes and scenarios, sample exercises and homework.

Procedure:
Recruitment: Dr Tay has conducted extensive consultations with academic partners, community leaders and members of the Chin, Kachin, and Rohingya communities to assess the feasibility and acceptability of the proposed project since 2013. Based on consensus from refugee communities, we intend to use a systematic informant-driven sampling method applying the following sequence: 1. community personnel who have received training will provide specific information about the nature of the project at weekly community meetings at community centers (attended by a large portion of refugees). Individual attendees who seek out additional information about voluntarily at the end of the meeting will be provided with as much detail as possible. 2. In addition, in their routine visits to all households (based on the comprehensive record of all residents), community leaders will include information about the project in discussions with residents, answering all questions and queries. 3. Those who consent to further contact will be phoned or visited by team workers who will explain the details of the study further and seek consent for potential participants to complete the tablet-based screening measures. Persons who wish further time to consider consent, will be given ample opportunity to do so. 4. Those who meet criteria for the intervention will be followed up by phone or home visits (depending on participant preference) to clarify further questions, concerns and expectations, and to consent if they so wish. If participants appeared ambivalent, they will be given sufficient time to consider their participation and our workers will follow up and re-approach if necessary. Our workers are trained specifically to ensure that there is no perceived duress in relation to participation at each step of the process, the emphasis being on respect for privacy and autonomy. At all times, participants will be assured by the community worker that their their decision and right to withdraw at any time will not have any adverse impact on their status, their asylum application, or the services to which they are entitled as refugees. In addition, participants are granted the full right to withdraw from the study at any point over the course of the intervention without any adverse consequence. 5. As indicated, one randomized, participants will attend the interventions at established NGO community centres where they are used to attending, places of safety given the provision of Malaysian law affording designated NGOs legal immunity against government interference.

Training in delivery of intervention: The therapy will be administered individually by trained counsellors trained and supervised by psychologists. Pre-treatment assessments: will be conducted by an assessment team blind to the treatment condition. Research team will apply a stringent procedure to ensure that participants and counsellors are concealed from the study objectives.

Treatment: IAT: individuals assigned to IAT will receive 6x1 hour sessions provided on a weekly basis. The sessions involve: (1) overview of the ADAPT model and refugee adaptation; (2) safety and security; (3) disrupted bonds and networks; (4) access to justice; (5) transition to new roles and identities; (6) living a meaningful life; (7) commitment to living a valued life.

Resources: Our team will include research assistants (recent medical graduates), certified healthcare professionals (psychologists, psychiatrists) and Malaysian academics in psychology, psychiatry, and behavioral science, all of whom are based in Malaysia with extensive knowledge of the local culture and customs of the Malaysian society, research sites, and relevant provisions. Our team will be based at Perdana University where we will have access to basic office equipment, facilities, and clinical services. We have engaged certified mental health professionals who are practicing psychologists and psychiatrists on a retainer contract who in addition to their clinical duties will assist in providing psychiatric care and psychotherapy if necessary. However, we anticipate the number of clients in need of such services will be in the minority with the majority being more likely prone to mild-moderate symptoms of depression and anxiety and will therefore be amenable to resilience building, directed coaching, CBT-based early intervention, services will be provided by trained coaches/counsellors. Training workshops will be organized prior to launching the platform to orient all persons involved to all aspects of the research including research protocol, recruitment procedure, methodology and other responsibilities.
Intervention code [1] 296811 0
Treatment: Other
Comparator / control treatment
The active control group will involve provision of World Health Organization Problem Management Plus (PM+). Individuals assigned to PM+ will receive 6x1 hour sessions on a weekly basis in which the core modules of PM-Plus will be implemented to help participants apply problem solving and other behavioral intervention strategies. The PM-Plus manual comprises 6 core modules: psycho-education, managing stress, behavioral activation, strengthening social support, stabilization and contingency planning.

The therapy will be administered individually by trained counselors and supervised by clinical psychologists. The sessions will take place at the respective community centers. There will be handouts, homework, and a mobile application to track treatment progress from session to session.
Control group
Active

Outcomes
Primary outcome [1] 300686 0
Mental disorders will be assessed using the Revised Harvard Trauma Questionnaire and the Refugee Mental Health Assessment Package (R-MHAP).

The mental disorder categories/reactions assessed include: post-traumatic stress disorder (PTSD)/Complex-PTSD, depression, generalized anxiety disorder, panic disorder, complicated grief, and intermittent explosive disorder. mental disorder categories/reactions assessed include: post-traumatic stress disorder (PTSD), depression, generalized anxiety disorder, complicated grief, psychotic symptoms, adult separation anxiety disorder, and intermittent explosive disorder.
Timepoint [1] 300686 0
Immediately post-treatment (primary time point), 3 months, 6 months and 12 months post-treatment.
Primary outcome [2] 302158 0
Resilience: will be assessed using an inventory of locally identified indicators of resilience including those identified from the literature (e.g., personal competence, tolerance of negative affect, acceptance of change, sense of control) - Composite outcome
Timepoint [2] 302158 0
Immediately post-treatment (primary time point), 3 months, 6 months and 12 months post-treatment.
Primary outcome [3] 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 [3] 303605 0
Immediately post-treatment (primary time point), 3 months, 6 months and 12 months post-treatment.
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
Immediately post-treatment, 3 months, 6 months and 12 months post-treatment.
Secondary outcome [2] 335008 0
Attachment styles will be assessed using Close Relationship Scale (Wei, Russell, Mallinckrodt, & Vogel, 2007).
Timepoint [2] 335008 0
Immediately post-treatment, 3 months, 6 months and 12 months post-treatment.
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
Immediately post-treatment, 3 months, 6 months and 12 months post-treatment.
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
Immediately post-treatment, 3 months, 6 months and 12 months post-treatment

Eligibility
Key inclusion criteria
The sample will comprise adults (18 years of age or older) who are members of the Chin, Kachin, and Rohingya communities.
Inclusion criteria are (a) witnessed or experienced a traumatic event; (b) met criteria of at least one current mental disorder assessed (post-traumatic stress disorder (PTSD)/Complex-PTSD, major depressive disorder and generalized anxiety disorder; Algorithms based on DSM-5 and ICD-11 criteria will be used to generate symptom based case assignments following the international diagnostic systems.
(c) at least one symptom of adaptive distress associated with each of the five psychosocial domains indexed using the ADAPT measure.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Adults unable to consent; persons with severe cognitive impairment and/or intellectual disability; persons with active psychotic symptoms; persons with active suicidal ideation. Individuals less than 18 years of age, pregnant women and prisoners.

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
Intention to treat analysis (ITT) will be applied to examine differences in baseline and post-treatment scores. All outcomes will be treated as continuous. A random-effect model will be used to estimate treatment effects including four assessment time points and counselor ID as random effects to account for within-person correlation across time and between-correlation by the counsellor. Gender, age, and other relevant sociodemographic characteristics will be examined separately as covariates. Missing data will be imputed using chain equations command in Stata which allows for the pooling of data according to Rubin’s rules.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 295294 0
GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601, Australia
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
Perdana University, Block B and D1, MAEPS Building, MARDI Complex, Jalan MAEPS Perdana, 43400 Serdang, Selangor, Malaysia.
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
UNSW Research Ethics & Compliance Support. The University of New South Wales. Sydney NSW 2052 Australia
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
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 PM+ 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.
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
Dr 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
Dr 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

No information has been provided regarding IPD availability
Summary results
No Results