Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000815460
Ethics application status
Approved
Date submitted
17/06/2016
Date registered
21/06/2016
Date last updated
3/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tell Your Story: An Online Intervention for Reducing Stigma in Traumatised Refugees
Scientific title
Tell Your Story: An Online Intervention for Reducing Stigma in Traumatised Refugees
Secondary ID [1] 289278 0
UNSW grant reference number: RG143112
Universal Trial Number (UTN)
U1111-1183-2978
Trial acronym
STRIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health Stigma 298851 0
Condition category
Condition code
Mental Health 298919 298919 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘Tell your Story” online intervention comprises of twelve short interactive web-based modules, containing short videos, activities and integrated measurement tools. A minimum of two weeks is needed to completed the twelve sessions, access is granted for a maximum of 30 days. These sessions cover topics including psychoeducation about PTSD (Modules 1-4), self-stigma and concerns about seeking about seeking help (Modules 5-8) and potential benefits of help-seeking and help-seeking planning tasks (Modules 9-12). Each module takes between 1 and 10 minutes to complete. The intervention will be available in Tamil, Farsi and Arabic. Community consultants from refugee communities have been involved in the design of the intervention and study, and will continue to be consulted throughout the project. Intervention adherence is assessed by number of modules completed. Strategies to improve fidelity include automated reminder emails.
Intervention code [1] 294817 0
Behaviour
Intervention code [2] 294822 0
Lifestyle
Intervention code [3] 295091 0
Treatment: Other
Comparator / control treatment
Randomized allocation to waitlist or intervention group. After an eight week waiting period, waitlist group members will be reallocated to the intervention group and receive the intervention.
Control group
Active

Outcomes
Primary outcome [1] 298384 0
Stigma related to seeking treatment for mental health problems, assessed with the 'Self-Stigma for Seeking Help Scale'.
Timepoint [1] 298384 0
Baseline, and at 4 and 8 weeks after intervention commencement
Primary outcome [2] 298403 0
Stigma related to PTSD, assessed with the 'Self-stigma for PTSD Scale'
Timepoint [2] 298403 0
Baseline, and at 4 and 8 weeks after intervention commencement
Primary outcome [3] 298597 0
General help-seeking for mental health problems, assessed with the 'General Help-Seeking Questionnaire'
Timepoint [3] 298597 0
Baseline, and at 4 and 8 weeks after intervention commencement
Secondary outcome [1] 324030 0
Actual help-seeking for mental health problems, assessed with the 'Actual Help-Seeking Questionnaire'
Timepoint [1] 324030 0
Baseline, and at 4 and 8 weeks after intervention commencement
Secondary outcome [2] 324687 0
Personal feedback/evaluation of the online program, assessed using a 21 item measure specifically regarding the intervention, designed by the researchers.
Timepoint [2] 324687 0
4 weeks after intervention commencement.

Eligibility
Key inclusion criteria
Male,
Refugee,
Speaks Arabic, Farsi or Tamil..
Subsyndromal Post-Traumatic Stress Disorder (PTSD). Assessed via telephone screening process.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Actively suicidal. Assessed via telephone screening process.

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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants will be randomly assigned to either receive the intervention immediately (intervention condition) or will be placed on an 8 week waiting list (waitlist control condition), From eight weeks, when granted access to the intervention, participants in the waitlist control condition will go through the same procedures as the intervention group,
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 200 participants are expected to take part in this intervention, with a drop-out rate of 25%. Research studies of on-line interventions for traumatised samples report attrition rates of between 16-30%, accordingly, 25% attrition is a conservative estimate in this study. Based on this estimate, it is anticipated that 150 participants (75 in the intervention group and 75 in the waitlist control condition) will complete the intervention. We conservatively expect at least a medium effect size (d=0.50) when comparing the intervention and control groups. To detect an effect size of 0.5, with 80% power at a=0.05, we calculated a necessary sample size of 64 participants per condition, meaning that an overall sample size of 150 will be adequate.

Hierarchical linear modelling analyses will be used to compare change in key outcome variables from pre- to post-intervention and at follow-up between the control and and intervention groups. We will implement lower-level mediation techniques to examine the direction of influence between changes in self-stigma and key psychological, social and system-level variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
31/05/2016
Date of last participant enrolment
Anticipated
31/08/2017
Actual
15/06/2017
Date of last data collection
Anticipated
Actual
20/09/2017
Sample size
Target
200
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293793 0
Charities/Societies/Foundations
Name [1] 293793 0
Beyondblue
Country [1] 293793 0
Australia
Funding source category [2] 293794 0
Charities/Societies/Foundations
Name [2] 293794 0
Movember Foundation
Country [2] 293794 0
Australia
Primary sponsor type
University
Name
The Refugee Trauma & Recovery Program, School of Psychology, UNSW Australia
Address
Refugee Trauma and Recovery Program
UNSW School of Psychology
High Street,
UNSW AUSTRALIA
SYDNEY NSW 2052
Country
Australia
Secondary sponsor category [1] 292627 0
None
Name [1] 292627 0
Address [1] 292627 0
Country [1] 292627 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295088 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 295088 0
Human Research Ethics Committee (HREC)
The University of New South Wales
UNSW Sydney, NSW, Australia, 2052
Ethics committee country [1] 295088 0
Australia
Date submitted for ethics approval [1] 295088 0
28/05/2015
Approval date [1] 295088 0
28/07/2015
Ethics approval number [1] 295088 0
HC15351

Summary
Brief summary
Refugee men exhibit elevated rates of Post-traumatic Stress Disorder (PTSD), an impairing psychological disorder. Refugee men are also highly vulnerable to the effects of self-stigma, which is associated with a range of negative outcomes, including unemployment and income loss, interpersonal difficulties, decreased self-esteem, and low treatment-seeking behaviour. This project proposes to test the efficacy of an evidence-based online intervention (“Tell Your Story” website) targeting self-stigma for refugee men with PTSD. Refugee men will be invited to take part in the study, recruited via caseworkers at refugee settlement agencies and advertisements within refugee networks, with 200 men expected to enter the study following telephone eligibility screening, information and consent processes. Participants will be randomly assigned to either receive the intervention immediately (intervention condition) or will be placed on an eight week waiting list (waitlist control condition), before access to the intervention is granted. From then on participants in the waitlist will go through the same procedure as the intervention group, The ‘Tell your Story” online intervention comprises of twelve short interactive web-based modules, containing short videos, activities and integrated measurement tools. It is available in Tamil, Farsi and Arabic. Community consultants from refugee communities have been involved in the design of the study and intervention and will continue to be consulted throughout the project. Participants will complete pre-intervention, post-intervention (4 weeks after commencing intervention) and follow-up (8 weeks after commencing intervention) measures of self-stigma, help-seeking intentions, help-seeking behaviours, PTSD symptoms and mental health-related quality of life online, with telephone support if required. Please see attached document 'Procedure Diagram' for an overview of study flow.
Trial website
www.rtrp-research.com/tellyourstory
Trial related presentations / publications
Public notes
Attachments [1] 936 936 0 0
/AnzctrAttachments/370752-370752-Study diagram - May update (1).pdf

Contacts
Principal investigator
Name 66066 0
Dr Angela Nickerson
Address 66066 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052
Country 66066 0
Australia
Phone 66066 0
+61 2 9385 0538
Fax 66066 0
Email 66066 0
a.nickerson@unsw.edu.au
Contact person for public queries
Name 66067 0
Dr Angela Nickerson
Address 66067 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052
Country 66067 0
Australia
Phone 66067 0
+61 2 9385 0538
Fax 66067 0
Email 66067 0
a.nickerson@unsw.edu.au
Contact person for scientific queries
Name 66068 0
Dr Angela Nickerson
Address 66068 0
Refugee Trauma and Recovery Program, School of Psychology, Mathews Building (F23), High Street, UNSW AUSTRALIA, Sydney 2052
Country 66068 0
Australia
Phone 66068 0
+61 2 9385 0538
Fax 66068 0
Email 66068 0
a.nickerson@unsw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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