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Trial registered on ANZCTR


Registration number
ACTRN12616001205426
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
31/08/2016
Date last updated
30/03/2022
Date data sharing statement initially provided
30/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The eResilience App Proof-of-Concept Clinical Trial among African participants who survived Humanitarian Emergencies
Scientific title
Responses to the Proof-of-Concept eResilience App for Humanitarian Emergencies
Secondary ID [1] 288599 0
none
Universal Trial Number (UTN)
U1111-1180-0347
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Posttraumatic Stress Disorder (PTSD) 296754 0
Condition category
Condition code
Mental Health 296985 296985 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A standardized protocol has been designed for the therapeutic intervention proposed for this experiment (App). Audio exercises recorded via a text-to-speech software will be delivered to participants via mobile technology for self-administration at home. There are 48 daily tasks ranging between 20'' to 10 minutes each, to be completed over a 1 week period (90-100 minutes per day for 7 consecutive days). Built as a multimodal approach, the tasks are categorized across seven different blocks.

Blocks 1, 3, 4, and 6 focus on body stabilization. It aims to promote a sense of safety, physiological awareness and regulation of the autonomic nervous system (ANS), optimizing heart rate variability (HRV), restoring parasympathetic tone, and enhancing inhibition ?of automated defense systems in non-life threatening environments. Techniques include somatic experiencing, breath work, biofeedback, muscle relaxation, guided visualization, and bilateral tapping during drumming sounds. Blocks 2 and 7 target the relational domain, introducing effective working models of attachment, self-reflective information processing and positive affect enhancement. Techniques include interpersonal skills development, initiation and engagement of altruistic tasks. Block 5 introduces mindfulness practice. Exercises focus on practice of mindful attention shifting from external surroundings (objects and sounds) to internal body awareness (grounding, sensation tracking, self-attribution, meaning-making, coping resources and positive affect), with the purpose of enhancing overall executive function capacities and further promote sense of internal safety.
Intervention code [1] 294004 0
Treatment: Other
Comparator / control treatment
Male and female subjects who meet the clinical or subclinical diagnostic criteria for PTSD will be assigned to the trauma group (n=30). Those who do not meet the clinical or subclinical diagnostic will be assigned to the control group (n=30). Both groups will equally receive the same intervention and complete all of the same intake, baseline and post-test assessments.
Control group
Active

Outcomes
Primary outcome [1] 297456 0
Change in resting state quantitative EEG
Timepoint [1] 297456 0
Baseline (day 1) and at post test (day 8) when intervention is concluded.
Primary outcome [2] 330944 0
Change in PTSD diagnostic criteria among experimental group.
Timepoint [2] 330944 0
Baseline (day 1), post test (day 8) when intervention is concluded, and at 3-6-12 month follow-ups.
Secondary outcome [1] 338026 0
Change in Cambridge Neuropsychological Test Automated Battery (CANTAB) scores.
Timepoint [1] 338026 0
Baseline (day 1) and at post test (day 8) when intervention is concluded.

Eligibility
Key inclusion criteria
Trauma Group:
(a) Meets the clinical or subclinical diagnostic criteria for PTSD.
(b) Ages 18-55.
(c) Liberian, Congolese, or Sudanese ethnicities.
(d) English proficiency.
(e) Departed Africa during war, fragile peace periods or the recent Ebola endemic (1989-2018).

Control Group:
(a) Must not meet the clinical or subclinical criteria for PTSD and other psychiatric or neurological disorders.
(b) Ages 18-55.
(c) Liberian, Congolese, or Sudanese ethnicities.
(d) English proficiency.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Trauma group:
(a) Current drug/alcohol abuse or dependency.
(b) Current use of psychotropic medication or use in the past 2 months.
(c) Severe medical condition.
(d) Genetic disorders.
(e) Concurrent psychotherapy for PTSD.
(f) Acute risk of suicide or homicide.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Male and female subjects who meet the clinical or subclinical diagnostic criteria for PTSD will be assigned to the trauma group (n=30). Those who do not meet the diagnostic will be assigned to the control group (n=30). Both groups will equally receive the same intervention and complete all of the same intake, baseline and post-test assessments. Experimental group subjects will in addition complete the CAPS-5 past week interview at post-treatment.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Clinical studies in PTSD have often achieved large effect sizes with samples of 30 patients per condition in accordance with the recommendations of the International Society of Traumatic Stress Studies Treatment Guidelines (2008).

Fast Fourier Transformation (FFT) will be utilized to analyse spectral band power across electrophysiological data. The pre to post the intervention design will allow for a multivariate repeated measures analysis of variance (ANOVA) that is aimed to be applied for a comparison of the trauma and control groups in respect to cognitive performance and electrophysiological oscillations. Chi-squared tests will be utilized to compare demographical and clinical characteristics between control and experimental groups. Correlation analysis will be applied to explore associations between the App, PTSD symptomatology, cognitive, and electrophysiological variables. Pair t-tests will be applied to explore changes between baseline and post intervention conditions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2018
Actual
3/09/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
14/01/2019
Actual
30/10/2020
Sample size
Target
60
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 12790 0
2050 - Camperdown
Recruitment postcode(s) [2] 22244 0
4575 - Birtinya
Recruitment postcode(s) [3] 22245 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 292953 0
University
Name [1] 292953 0
The University of Sydney
Country [1] 292953 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
New South Wales, 2006
Country
Australia
Secondary sponsor category [1] 291724 0
Individual
Name [1] 291724 0
Brian O'Toole
Address [1] 291724 0
THE UNIVERSITY OF SYDNEY
94 Mallett Street Camperdown, NSW, 2050
Country [1] 291724 0
Australia
Other collaborator category [1] 280048 0
University
Name [1] 280048 0
Sunshine Coast Mind and Neuroscience, Thompson Institute, University of the Sunshine Coast
Address [1] 280048 0
12 Innovation Parkway, Birtinya, QLD 4575
Country [1] 280048 0
Australia
Other collaborator category [2] 282232 0
Charities/Societies/Foundations
Name [2] 282232 0
Sync Body-Brain Health
Address [2] 282232 0
3/1 Watson St, Currimundi QLD 4551 Australia
Country [2] 282232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294459 0
University of Sydney - Human Research Ethics Committee
Ethics committee address [1] 294459 0
Level 6, Jane Foss Russell
The University of Sydney
NSW 2006 Australia
Ethics committee country [1] 294459 0
Australia
Date submitted for ethics approval [1] 294459 0
18/10/2015
Approval date [1] 294459 0
16/10/2017
Ethics approval number [1] 294459 0
2017/088

Summary
Brief summary
The central purpose of this research is to examine the feasibility of a self-administered mobile intervention (App) for traumatic stress in humanitarian emergencies. The intervention will be initially examined with African refugees in Australia that meet the clinical or subclinical diagnostic criteria for posttraumatic disorder (PTSD). The App was created as part of this project, and comprises of body stabilization, cognitive mindfulness and interpersonal exercises across seven blocks. Objective electrophysiological and cognitive measures have been selected to predict intervention outcome alongside clinical measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61486 0
Prof Caroline Hunt
Address 61486 0
The University of Sydney, Sydney 2006, NSW Australia
Country 61486 0
Australia
Phone 61486 0
+61 291144340
Fax 61486 0
Email 61486 0
[email protected]
Contact person for public queries
Name 61487 0
Janaina Pinto
Address 61487 0
The University of Sydney, Sydney 2006, NSW Australia
Country 61487 0
Australia
Phone 61487 0
+61 4 8124 4463
Fax 61487 0
Email 61487 0
[email protected]
Contact person for scientific queries
Name 61488 0
Janaina Pinto
Address 61488 0
The University of Sydney, Sydney 2006, NSW Australia
Country 61488 0
Australia
Phone 61488 0
+61 4 8124 4463
Fax 61488 0
Email 61488 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 de-identified study data will be made available via the University of Sydney library.
When will data be available (start and end dates)?
upon first publication of results, expected in 2022. There will be no end date for data access.
Available to whom?
Public open access
Available for what types of analyses?
All analyses
How or where can data be obtained?
The University of Sydney Library
https://www.library.sydney.edu.au/databases/
+61 2 9351 3981


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.