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Trial registered on ANZCTR


Registration number
ACTRN12619001386123
Ethics application status
Approved
Date submitted
5/10/2019
Date registered
10/10/2019
Date last updated
12/11/2021
Date data sharing statement initially provided
10/10/2019
Date results information initially provided
2/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Testing Group Psychological Help for Adult Syrian Refugees in Jordan
Scientific title
Effectiveness of Group Psychological Help for Adults Impaired by Distress in Communities Exposed to Adversity
Secondary ID [1] 298886 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record
The pilot trial for this study is registered under ACTRN12619000340134

Health condition
Health condition(s) or problem(s) studied:
Anxiety 313853 0
Depression 313854 0
Posttraumatic stress disorder 313855 0
Condition category
Condition code
Mental Health 312253 312253 0 0
Anxiety
Mental Health 312254 312254 0 0
Depression
Mental Health 312255 312255 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this trial. Arm 1: Group Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is group-administered once-weekly for 90 minutes over 5 weeks for adult Syrian refugees. Group Problem Management Plus includes skills in psychoeducation, problem solving, arousal management, behavioural activation, and instruction in social support. Sessions will occur in centres in the Azraq Refugee Camp, Jordan. The duration of the study for any participant will conclude after a 12-month follow-up assessment, resulting in participation duration of 60 weeks. Therapy is provided by local health workers.
Intervention code [1] 315149 0
Behaviour
Comparator / control treatment
Enhanced Treatment as Usual comprises normal treatment provided by local counselors. Enhanced Treatment as Usual involves referral to local psychosocial services, as well as provision of basic education about common psychological problems. The duration of the study for any participant will conclude after a 12-month follow-up assessment, resulting in participation duration of 60 weeks. Therapy is provided by local health workers.
Control group
Active

Outcomes
Primary outcome [1] 320900 0
Anxiety that is measured by the Hopkins Symptom Checklist
Timepoint [1] 320900 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60). The primary timepoint is the 3-month follow-up assessment.
Primary outcome [2] 320901 0
Depression that is measured by the Hopkins Symptom Checklist
Timepoint [2] 320901 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60). The primary timepoint is the 3-month follow-up assessment.
Secondary outcome [1] 373295 0
Posttraumatic stress disorder as measured by the Posttraumatic Stress Checklist
Timepoint [1] 373295 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [2] 373296 0
Prolonged grief as measured by the Prolonged Grief as measured by adapted version of the Prolonged Grief-13
Timepoint [2] 373296 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [3] 373297 0
Functional impairment as measured by the WHODAS
Timepoint [3] 373297 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [4] 373298 0
Personally identified problems as measured by the PSYCHLOPS
Timepoint [4] 373298 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [5] 373299 0
Prodromal psychotic symptoms as measured by the Brief Prodromal Questionnaire
Timepoint [5] 373299 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [6] 373300 0
Children's mental health as measured by the Pediatric Symptom Checklist
Timepoint [6] 373300 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)
Secondary outcome [7] 375547 0
Parenting skills as measured by the Alabama Parenting Questionnaire
Timepoint [7] 375547 0
Pretreatment (week 1), posttreatment (week 6), and 3-month follow-up (week 18). 12-month follow-up (week 60)

Eligibility
Key inclusion criteria
Inclusion criteria are (a) Syrian refugees, (b) psychological distress as measured by K10 scores of >15 and impaired functioning as measured by WHODAS score of >16, (c) can understand instructions, and (d) has a child in the ages 10-16 years.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include (a) people who are at risk for harming self and/or others, and (b) people indicating they plan to return to Syria in the next 6 months

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)
Participants will be adult Syrian refugees indicating distress. Participants wishing to participate will be randomly allocated according to a random numbers system administered by an individual who independent of the study and who works at a site that is independent from the trial centre
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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
A total number of 480 participants will be included in the trial. Based on previous studies of PM+ (Bryant and Rahman), we aimed for a conservative effect size of 0.4 in the gPM+ group at 3-months. Power calculations suggest a minimum sample size of 133 per arm (power=0.90, a=0.05, two-sided). Taking into account an expected 40% attrition at 3-months follow-up, based on a feasibility study, we aim to include a total of 240 participants per arm. Analyses of the relative efficacy of the PM+ program will be evaluated using linear mixed models analysis. The Level 1 model will represent within-patient change over time, and the Level 2 model will predict variation in within-patient change over time and encompass between-patient variables (treatment condition). Primary outcome will comprise the HSC at 3 month follow-up.

Recruitment
Recruitment status
Completed
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] 21730 0
Jordan
State/province [1] 21730 0
Azraq Refugee Camp

Funding & Sponsors
Funding source category [1] 303427 0
Government body
Name [1] 303427 0
NHMRC
Address [1] 303427 0
Level 1, 16 Marcus Clarke Street, Canberra, ACT, 2601
Country [1] 303427 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 303477 0
None
Name [1] 303477 0
Address [1] 303477 0
Country [1] 303477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303958 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 303958 0
UNSW Sydney
Sydney
NSW 2052
Ethics committee country [1] 303958 0
Australia
Date submitted for ethics approval [1] 303958 0
05/06/2017
Approval date [1] 303958 0
27/07/2017
Ethics approval number [1] 303958 0
HC17520

Summary
Brief summary
The rationale of the study is to evaluate the efficacy of a low intensity intervention to reduce mental health problems in adult refugees. This study compares the relative efficacy of (a) PM+ program, and (b) Enhanced Treatment as Usual. It is hypothesised that PM+ will lead to greater symptom reduction than Enhanced Treatment as Usual.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95378 0
Prof Richard Bryant
Address 95378 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 95378 0
Australia
Phone 95378 0
+61293853640
Fax 95378 0
+61 293853641
Email 95378 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 95379 0
Prof Richard Bryant
Address 95379 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 95379 0
Australia
Phone 95379 0
+61293853640
Fax 95379 0
+61 293853641
Email 95379 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 95380 0
Prof Richard Bryant
Address 95380 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 95380 0
Australia
Phone 95380 0
+61293853640
Fax 95380 0
+61 293853641
Email 95380 0
r.bryant@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?
All de-identified data
When will data be available (start and end dates)?
Data will only be available to the STRENGTHS consortium, of which this study is one site. Following analysis of the IPD across sites in this consortium, this study's data will be available. There is no end date for when this data will be available.
Available to whom?
Researchers wishing to conduct re-analyses of the data.
Available for what types of analyses?
Meta-analyses or re-analyses of subgroups
How or where can data be obtained?
By emailing the Principal Investigator (email: r.bryant@unsw.edu.au).
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary