Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000999639
Ethics application status
Approved
Date submitted
18/08/2023
Date registered
13/09/2023
Date last updated
20/05/2024
Date data sharing statement initially provided
13/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Efficacy of A Conversational Agent's Impact on Self-Efficacy and Psychological Distress Following Injury: A Pilot Randomised Controlled Trial
Scientific title
Can interacting with a digital conversational agent which provides psychoeducation on adaptive cognitive emotion regulation strategies, increase an injured person's perceived coping self-efficacy when navigating a personal injury compensation scheme?
Secondary ID [1] 310420 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ERICA -Emotion Regulation Intervention Conversational Agent
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 331180 0
Condition category
Condition code
Public Health 327954 327954 0 0
Health promotion/education
Mental Health 328042 328042 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ERICA is an emotion regulation psychoeducation program that is delivered via a digital conversational agent, ERICA interacts with users via text and speech and users interact with ERICA via selecting options from pre-defined list. The program provides descriptive examples that aid in self reflection and practice activities to develop adaptive cognitive emotion regulation skills. The ERICA program has six different conversations/dialogues - the first dialogue explores techniques to assist with positive refocusing, the second focuses on the processes of planning and problem solving. The next two dialogues explore acceptance and reappraisal while the final two conversations focus on techniques to help put things in perspective. Each conversational dialogue takes approximately 10-15 minutes to work through (dependent upon answers selected) and each week, for three weeks, participants receive two emails (3 days apart) with a link to the next dialogue. Participants can access the links anytime over the four week intervention period (however they are encouraged to access each link on the day it is received). Participant interaction with ERICA will be captured via a system log which records login date, response options selected and the total length of time spent each session.
Intervention code [1] 326814 0
Behaviour
Intervention code [2] 326815 0
Prevention
Intervention code [3] 326883 0
Treatment: Other
Comparator / control treatment
The comparator group is treatment as usual. This consists of regular contact with their personal injury claims consultant and prompting to talk to their GP if they express heightened psychological distress. The comparator group will be offered the intervention after the 4 week intervention period. They will be sent a webink to the ERICA program and will be advised that they can access at anytime for the next 4 weeks.
Control group
Active

Outcomes
Primary outcome [1] 335810 0
Change in Self-Efficacy as assessed by the General Self-Efficacy Scale (GSE)
Timepoint [1] 335810 0
Baseline, 4 weeks and 8 weeks (primary endpoint) post intervention commencement
Primary outcome [2] 335811 0
Change in the reported frequency of use of adaptive cognitive emotion regulation strategies assessed by the Cognitive Emotion Regulation Quesionnaire Short Form (CERQ-SF)
Timepoint [2] 335811 0
Baseline, 4 weeks and 8 weeks (primary endpoint) post intervention commencement
Secondary outcome [1] 425761 0
Change in willingness to seek mental health support as assessed by the Attitudes Towards Seeking Psychological Help Scale -Short Form (ATSPPH- SF)
Timepoint [1] 425761 0
Baseline, 4 and 8 weeks post intervention commencement
Secondary outcome [2] 425762 0
Change in psychological distress as assessed via the Kessler Psychological Distress Scale (K10)
Timepoint [2] 425762 0
Baseline, 4 and 8 weeks post intervention commencement
Secondary outcome [3] 425763 0
Satisfaction with ERICA program as assessed via Client Satisfaction Questionnaire adapted to Internet Interventions (CSQ-II)
Timepoint [3] 425763 0
Intervention group 4 weeks post intervention commencement, Comparator group 8 weeks post intervention commencement
Secondary outcome [4] 425764 0
Participant's perception of the usability of the program as assessed via the system usability scale (SUS)
Timepoint [4] 425764 0
Intervention group 4 weeks post intervention commencement, comparator group 8 weeks post intervention commencement

Eligibility
Key inclusion criteria
Lodged a personal injury claim
Aged 18 years or over
Sustained a minor or moderate injury (soft tissue injury or simple orthopaedic injury)
Not currently receiving professional psychological or psychiatric services
Have sufficient English language skills to engage with the ERICA program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those screened as > 29 on the K10
Those involved in a fatality collision
Those receiving professional psychological or psychiatric services
Having insufficient language skills to engage with the ERICA program

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 randomisation by computer (Qualtrics Platform)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by computer software (Qualtrics)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the sample. Chi square tests and t-tests will be used to assess for differences between baseline and follow-up and one-way ANOVAs will be used to assess for group by time interactions. Intention to treat analyses will be used to examine differences between the intervention and control group on observed outcomes. A modified intention to treat analysis (mITT) will also be conducted with completers being defined as participants who log onto the ERICA program on at least one occasion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/10/2023
Actual
28/02/2024
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
80
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA
Recruitment postcode(s) [1] 41151 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 314627 0
Other Collaborative groups
Name [1] 314627 0
Digital Health Cooperative Research Centre
Country [1] 314627 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
School of ComputingMacquarie University, 4 Research Park Dr, Macquarie University NSW 2109 Australia
Country
Australia
Secondary sponsor category [1] 316589 0
Commercial sector/Industry
Name [1] 316589 0
Insurance Australia Group (IAG)
Address [1] 316589 0
Darling Park, Tower Two, 201 Sussex St, Sydney NSW 2000
Country [1] 316589 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313650 0
Macquarie University Human Research Ethics Committee (Human Sciences and Humanities)
Ethics committee address [1] 313650 0
Ethics committee country [1] 313650 0
Australia
Date submitted for ethics approval [1] 313650 0
14/08/2023
Approval date [1] 313650 0
20/10/2023
Ethics approval number [1] 313650 0
520231593453528

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

Contacts
Principal investigator
Name 128878 0
Prof Deborah Richards
Address 128878 0
School of ComputingFaculty of Science and Engineering4 Research Park Dr, Macquarie University NSW 2109
Country 128878 0
Australia
Phone 128878 0
+61 2 9850 9567
Fax 128878 0
+61 2 9850 9551
Email 128878 0
[email protected]
Contact person for public queries
Name 128879 0
Deborah Richards
Address 128879 0
School of ComputingFaculty of Science and Engineering4 Research Park Dr, Macquarie University NSW 2109
Country 128879 0
Australia
Phone 128879 0
+61 2 9850 9567
Fax 128879 0
+61 2 9850 9551
Email 128879 0
[email protected]
Contact person for scientific queries
Name 128880 0
Deborah Richards
Address 128880 0
School of ComputingFaculty of Science and Engineering4 Research Park Dr, Macquarie University NSW 2109
Country 128880 0
Australia
Phone 128880 0
+61 2 9850 9567
Fax 128880 0
+61 2 9850 9551
Email 128880 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• The data will be ascribed “restricted access” meaning that researchers wishing to access the de-identified data, will need to contact Macquarie University who will then seek permission from IAG (Industry Partner).

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• Any purpose approved by IAG

When can requests for individual participant data be made (start and end dates)?
From:
Data will be uploaded to the Macquarie University Data Repository in December 2024, no end date has been determined at this stage

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• As data access will be restrictied, researchers will need to email Professor Deborah Richards (Principal Investigator) to request data access. Professor Richards will liaise with IAG the Industry Partner who own the data. Professor Richards email address is [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.