Skip to content

The eResilience App Proof-of-Concept Clinical Trial among African participants who survived Humanitarian Emergencies

Responses to the Proof-of-Concept eResilience App for Humanitarian Emergencies

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616001205426
Enrollment
70
Registered
2016-08-31
Start date
2018-09-03
Completion date
2018-12-31
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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. Blo

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.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026