Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000340134
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
5/03/2019
Date last updated
12/11/2021
Date data sharing statement initially provided
5/03/2019
Date results information initially provided
26/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of Testing Group Psychological Help for Adult Syrian Refugees in Jordan
Scientific title
Pilot Study of Effectiveness of Group Psychological Help for Adults Impaired by Distress in Communities Exposed to Adversity
Secondary ID [1] 296959 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 310920 0
Depression 310921 0
Posttraumatic stress disorder 310922 0
Condition category
Condition code
Mental Health 309582 309582 0 0
Anxiety
Mental Health 309583 309583 0 0
Depression
Mental Health 309584 309584 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two arms to this pilot 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 post-intervention assessment, resulting in participation duration of 7 weeks. Therapy is provided by local health workers.
Intervention code [1] 313230 0
Behaviour
Intervention code [2] 313231 0
Treatment: Other
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 an assessment 7 weeks after the baseline assessment, resulting in participation duration of 7 weeks..
Control group
Active

Outcomes
Primary outcome [1] 318543 0
Anxiety that is measured by the Hopkins Symptom Checklist
Timepoint [1] 318543 0
Pretreatment (week 1), and posttreatment (week 6)
Primary outcome [2] 318544 0
Depression that is measured by the Hopkins Symptom Checklist
Timepoint [2] 318544 0
Pretreatment (week 1), and posttreatment (week 6)
Secondary outcome [1] 365320 0
Posttraumatic stress disorder as measured by the Posttraumatic Stress Checklist
Timepoint [1] 365320 0
Pretreatment (week 1), and posttreatment (week 6)
Secondary outcome [2] 365321 0
Children's mental health as measured by the Pediatric Symptom Checklist.
Timepoint [2] 365321 0
Pretreatment (week 1), and posttreatment (week 6)

Eligibility
Key inclusion criteria
Inclusion criteria are (a) Syrian refugees, (b) psychological distress as measured by K10 scores of >16 and impaired functioning as measured by WHODAS score of >17, and (c) can understand instructions.
Minimum age
18 Years
Maximum age
50 Years
Sex
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 net 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
This study represents a pilot trial and is not intended to be powered to detect significant differences between treatment arms. 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/03/2019
Actual
11/03/2019
Date of last participant enrolment
Anticipated
11/03/2019
Actual
20/03/2019
Date of last data collection
Anticipated
29/04/2019
Actual
30/04/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 21155 0
Jordan
State/province [1] 21155 0
Azraq Refugee Camp

Funding & Sponsors
Funding source category [1] 301530 0
Government body
Name [1] 301530 0
NHMRC
Country [1] 301530 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 301231 0
None
Name [1] 301231 0
Address [1] 301231 0
Country [1] 301231 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302269 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 302269 0
UNSW Sydney
Sydney
NSW 2052
Ethics committee country [1] 302269 0
Australia
Date submitted for ethics approval [1] 302269 0
05/06/2017
Approval date [1] 302269 0
27/07/2017
Ethics approval number [1] 302269 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 89638 0
Prof Richard Bryant
Address 89638 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 89638 0
Australia
Phone 89638 0
+61293853640
Fax 89638 0
+61 293853641
Email 89638 0
[email protected]
Contact person for public queries
Name 89639 0
Prof Richard Bryant
Address 89639 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 89639 0
Australia
Phone 89639 0
+61293853640
Fax 89639 0
+61 293853641
Email 89639 0
[email protected]
Contact person for scientific queries
Name 89640 0
Prof Richard Bryant
Address 89640 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 89640 0
Australia
Phone 89640 0
+61293853640
Fax 89640 0
+61 293853641
Email 89640 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 the STRENGTHS consortium has completed multi-site analyses. This will occur after 2022; 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 the Richard Bryant.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Akhtar A, Giardinelli L, Bawaneh A, Awwad M, Al-Ha... [More Details] 376645-(Uploaded-19-09-2021-20-33-10)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.