Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001731886
Ethics application status
Approved
Date submitted
22/11/2021
Date registered
20/12/2021
Date last updated
1/09/2024
Date data sharing statement initially provided
20/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Tell Your Story: Can an Online Intervention Reduce Stigma and Increase Help-Seeking in Refugee Men and Women?
Scientific title
Tell Your Story: Evaluating the Effect of an Online Intervention on Mental Health Self-Stigma and Help-Seeking in Refugee Men and Women.
Secondary ID [1] 305744 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Stigma 324241 0
Post-Traumatic Stress Disorder 324646 0
Condition category
Condition code
Mental Health 321728 321728 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Tell Your Story (TYS) is an online intervention specifically designed to reduce mental health stigma and increase help-seeking in refugees. The TYS intervention was developed by the Refugee Trauma and Recovery Program (RTRP) in collaboration with cultural advisors to optimize cultural sensitivity and relevance. The intervention includes evidence-based, stigma reduction strategies: social contact, psychoeducation and cognitive re-appraisal of PTSD symptoms and help-seeking concerns. This is achieved via short videos, information and interactive activities organized into 12 short modules. Each module has a topic targeting either self-stigma or help-seeking and each take approximately 10-15 minutes to complete. Participants will not be required to complete homework activities outside of the 12 short modules.

Tell Your Story was originally created specifically for refugee men. This trial aims to extend the intervention to refugee women. To this end, men and women will complete a gender specific version of Tell Your Story given that stigma presents differently across genders. To account for this, modules are consistent across genders, however some aspects differ. For example, the short videos will feature either refugee men or women depending on the TYS version. The female adaptation was conducted following a literature search, consultation with cultural advisors and clinicians experienced in working with refugees experiencing mental health difficulties.
Additionally, modules 11 and 12 are personalized for each participant based on their responses in earlier activities. For example, participants complete a help-seeking plan which includes the specific help-seeking benefits they endorsed in module 8.

Participants will have access to the intervention for four weeks which they progress through at their own pace. The intervention will be delivered online and in language for the participant group (Arabic-speaking). Intervention adherence will be assessed by number of modules completed.
Intervention code [1] 322143 0
Behaviour
Intervention code [2] 322144 0
Lifestyle
Intervention code [3] 322145 0
Treatment: Other
Comparator / control treatment
Randomised allocation to waitlist or intervention group. Participants in the waitlist control group will receive access to the intervention for 4 weeks after their final assessment (i.e. 4 months since being involved in the trial).
Control group
Active

Outcomes
Primary outcome [1] 329488 0
Between-group differences in change in self-stigma related to seeking treatment for mental health problems, assessed with the "Self-Stigma of Seeking Help Scale" (SSOSH).
Timepoint [1] 329488 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention). Post-intervention is defined as the primary endpoint.
Primary outcome [2] 329491 0
Between-group differences in change in self-stigma related to PTSD symptoms will be assessed by the 24-item version of the "Internalised Stigma of Mental Illness Scale" (ISMI) adapted to PTSD.
Timepoint [2] 329491 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention). Post-intervention is defined as the primary endpoint.
Primary outcome [3] 329492 0
Between-group differences in change in help-seeking. This is a composite primary outcome and the following will be included in its measurement:
1. Help-seeking behaviour assessed by 1a) an adapted version of the "Actual Help-seeking questionnaire (AHSQ)", 1b) a measure of help-seeking steps developed for the purposes of this study 1c) as an objective measure of help-seeking, participants indicate either "yes" or "no" to a question asking if they would like to receive the contact details of local mental health services.
2. Help-seeking intentions assessed by an adapted version of the "General Help-seeking questionnaire. (GHSQ)".
Timepoint [3] 329492 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention). Note that 1c will just be measured at post-intervention and follow-up. Post-intervention is defined as the primary endpoint.
Secondary outcome [1] 402804 0
Between group differences in change in self-esteem as assessed by the "Empowerment Scale" (self-esteem/self-efficacy subscale).
Timepoint [1] 402804 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention).
Secondary outcome [2] 402805 0
Between group differences in change in future self-efficacy as assessed by the "Hope Scale".
Timepoint [2] 402805 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention).
Secondary outcome [3] 402806 0
Between group differences in change in help-seeking beliefs as assessed by the "Help-Seeking Beliefs Scale" developed for the purposes of this study.
Timepoint [3] 402806 0
Baseline, post-intervention (4 weeks since intervention commencement) and follow-up (3 months since post-intervention).

Eligibility
Key inclusion criteria
1.Refugee or asylum seeker background
2.Ability to read in Arabic
3. At least 18 years old
4. Internet access
5. At least sub-threshold levels of PTSD (defined as meeting criteria for cluster B intrusive symptoms and at least one other symptom cluster on the PC-PTSD measure)
6. The presence of self-stigma relating to mental health or help-seeking (defined as endorsing a response greater than or equal to 3 on at least one of the items taken from the ISMI or SSOSH)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Currently seeing a mental health professional regularly (defined as once a month)
2) Actively suicidal (significant suicidal intent or a plan for suicide)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation by computer (online program) after eligibility determined and baseline completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be based on a 1:1 allocation ratio (with 2 groups) by a computerised program. To ensure balance between groups the allocation will be stratified by gender (male vs female). The research coordinator will input the necessary data needed to generate the allocation (as described above) into the program which will reveal the allocation sequence to the research coordinator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis



Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
9/05/2022
Actual
4/05/2022
Date of last participant enrolment
Anticipated
1/07/2023
Actual
18/07/2023
Date of last data collection
Anticipated
1/10/2023
Actual
23/11/2023
Sample size
Target
100
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310103 0
University
Name [1] 310103 0
UNSW
Country [1] 310103 0
Australia
Primary sponsor type
Individual
Name
Professor Angela Nickerson
Address
School of Psychology, Mathews Building (Entry via Gate 11 Botany St)
UNSW Sydney
NSW
2052
Country
Australia
Secondary sponsor category [1] 311168 0
University
Name [1] 311168 0
University of New South Wales
Address [1] 311168 0
School of Psychology, Mathews Building (Entry via Gate 11 Botany St)
UNSW Sydney
NSW
2052
Country [1] 311168 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309793 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 309793 0
Ethics committee country [1] 309793 0
Australia
Date submitted for ethics approval [1] 309793 0
04/05/2021
Approval date [1] 309793 0
17/06/2021
Ethics approval number [1] 309793 0
HC210360

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

Contacts
Principal investigator
Name 115406 0
Prof Angela Nickerson
Address 115406 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 115406 0
Australia
Phone 115406 0
+61 2 9385 0538
Fax 115406 0
Email 115406 0
[email protected]
Contact person for public queries
Name 115407 0
Angela Nickerson
Address 115407 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052, NSW
Country 115407 0
Australia
Phone 115407 0
+61 2 9385 0538
Fax 115407 0
Email 115407 0
[email protected]
Contact person for scientific queries
Name 115408 0
Angela Nickerson
Address 115408 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052 NSW
Country 115408 0
Australia
Phone 115408 0
+61 2 9385 0538
Fax 115408 0
Email 115408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.