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Trial registered on ANZCTR


Registration number
ACTRN12619000168156
Ethics application status
Approved
Date submitted
28/01/2019
Date registered
5/02/2019
Date last updated
21/02/2020
Date data sharing statement initially provided
5/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of Testing Group Psychological Help for Syrian Refugees in Jordan
Scientific title
Pilot Study of Effectiveness of Group Psychological Help for Syrian Refugees Impaired by Distress
Secondary ID [1] 297219 0
Nil
Universal Trial Number (UTN)
Trial acronym
PM+ Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychological distress 311269 0
Depression 311270 0
Posttraumatic stress disorder 311271 0
Condition category
Condition code
Mental Health 309889 309889 0 0
Depression
Mental Health 309890 309890 0 0
Anxiety
Mental Health 309891 309891 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: Problem Management Plus. Arm 2: Enhanced Treatment as Usual. Therapy is group-administered once-weekly for 90 minutes over 5 weeks for adults. Problem Management Plus includes skills in psychoeducation, problem solving, arousal management, behavioural activation, and accessing social support. 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 trained local health workers. Treatment adherence will be measured by independent assessors observing random sessions, as well as facilitators completing treatment component checklist.
Intervention code [1] 313467 0
Behaviour
Intervention code [2] 313468 0
Treatment: Other
Comparator / control treatment
Enhanced Treatment as Usual comprises feedback by independent health workers who attend refugees' caravans to inform them about their mental health and sources of assistance from local psychosocial services. 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] 318833 0
Depression as measured by the Hopkins Symptom Checklist
Timepoint [1] 318833 0
Pretreatment (week 1), and posttreatment (week 7)
Primary outcome [2] 318834 0
Anxiety as measured by the Hopkins Symptom Checklist
Timepoint [2] 318834 0
Pretreatment (week 1), and posttreatment (week 7)
Secondary outcome [1] 366197 0
Posttraumatic stress as measured by the Posttraumatic Stress Disorder Checklist
Timepoint [1] 366197 0
Pretreatment (week 1), and posttreatment (week 7)
Secondary outcome [2] 366198 0
Participant's child's psychological distress as measured by the Pediatric Symptom Checklist
Timepoint [2] 366198 0
Pretreatment (week 1), and posttreatment (week 7)

Eligibility
Key inclusion criteria
Inclusion criteria are (a) Syrian refugee residing in Azraq Refugee Camp, (b) aged > 18 years, (c) scores on Kessler-10 > 15.9 and WHODAS > 16, (c) can understand instructions, (d) Arabic speaking, and (e) has a child between 10-16 years.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are (a) significant cognitive impairment or severe neurological impairments, (b) at risk of imminent suicide, (c) suffering from acute medical conditions, or (d) suffering from severe mental disorders (e.g. psychotic disorders)

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 moderate 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 Hopkins Symptom Checklist..

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2019
Actual
11/02/2019
Date of last participant enrolment
Anticipated
15/02/2019
Actual
25/03/2019
Date of last data collection
Anticipated
5/04/2019
Actual
29/04/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 21226 0
Jordan
State/province [1] 21226 0
Azraq Refugee Camp

Funding & Sponsors
Funding source category [1] 301768 0
Government body
Name [1] 301768 0
NHMRC
Country [1] 301768 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney
NSW 2052
Country
Australia
Secondary sponsor category [1] 301512 0
None
Name [1] 301512 0
Address [1] 301512 0
Country [1] 301512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302486 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 302486 0
Ethics committee country [1] 302486 0
Australia
Date submitted for ethics approval [1] 302486 0
25/07/2017
Approval date [1] 302486 0
27/07/2017
Ethics approval number [1] 302486 0
HC17520

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

Contacts
Principal investigator
Name 90386 0
Prof Richard Bryant
Address 90386 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 90386 0
Australia
Phone 90386 0
+61293853640
Fax 90386 0
+61 293853641
Email 90386 0
r.bryant@unsw.edu.au
Contact person for public queries
Name 90387 0
Richard Bryant
Address 90387 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 90387 0
Australia
Phone 90387 0
+61293853640
Fax 90387 0
+61 293853641
Email 90387 0
r.bryant@unsw.edu.au
Contact person for scientific queries
Name 90388 0
Richard Bryant
Address 90388 0
School of Psychology
University of New South Wales
Sydney NSW 2052
Country 90388 0
Australia
Phone 90388 0
+61293853640
Fax 90388 0
+61 293853641
Email 90388 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?
Baseline and posttreatment data
When will data be available (start and end dates)?
Following publication of the study outcomes, and sharing of data with our consortium members. Date unknown.
Available to whom?
Initially to STRENGTHS collaborators, and then it will be available for open access.
Available for what types of analyses?
Individual person data meta-analysis of treatment outcomes
How or where can data be obtained?
It will be made available via Figshare


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
No additional documents have been identified.