Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000720617
Ethics application status
Approved
Date submitted
8/06/2023
Date registered
5/07/2023
Date last updated
5/07/2023
Date data sharing statement initially provided
5/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of the DRIVing my own mental health Recovery (Driv-R) app - efficacy of a mobile app to support individuals' control over their own mental health recovery
Scientific title
Pragmatic trial of the Driv-R App. A codesigned app to support individuals to drive their own mental health recovery
Secondary ID [1] 309866 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DRIV-R (DRIVing my own mental health Recovery)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental illness 330305 0
Condition category
Condition code
Mental Health 327164 327164 0 0
Schizophrenia
Mental Health 327165 327165 0 0
Depression
Mental Health 327166 327166 0 0
Anxiety
Mental Health 327167 327167 0 0
Psychosis and personality disorders
Mental Health 327168 327168 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DRIVing my mental health Recovery (Driv-R) app. A smartphone app, based on the Recovery Assessment Scale - Domains and Stages (RAS-DS), and co-designed to provide education and support to mental health consumers and mental health workers to work more collaboratively and support mental health consumers to take a more active leadership role in their own mental health recovery.

The Driv-R app is currently being co-desgined by a team of 24 service users and mental health workers alongside the research team. The co-design team is made up of an equal mix of service users and service providers. The service user/consumer participants are individuals who are accessing a range of clinical and non-clinical mental health services and who have all experienced mental health challenges, service use and recovery. The mental health worker participants are a mix of clinical workers (e.g., occupational therapists, nurses, etc) and non-clinical workers such as peer workers (individuals with their own lived experiences of mental health challenges and recovery) and other mental health support workers from a range of backgrounds.

The co-design workshops will include the following:
(i) an initial 2-day "ideate" lab workshop that encourages all co-designers to consider design components
(ii) following the initial design labs, the co-design team will be split into 2 groups - the deign team and the testing team
(iii) the design team will be presented with wire-frames and prototypes of app designs and refine these and provide feedback over a series of two day-long workshops
(iv) the design team, tester team, the research team and app developers will meet over a one day intensive design lab
(v) the tester team will spend two more day-long workshops exploring and refining the app to ensure it addresses the needs of the anticipated user group.

It is anticipated that the app will include features such as:
(i) the opportunity to complete the RAS-DS - a 38-item self-report measure of mental health recovery
(ii) presentation of self-rated recovery based on the each item and domain
(iii) opportunity to explore each domain and suggestions as to goals / ideas that might be useful to promote recovery in that domain (potentially based on the RAS-DS workbook [https://ras-ds.net.au/workbooks])

Depending on what the co-design workshops prioritise, the content could include a variety of resources, but the main content will include features that allow tracking recovery scores over time (from the RAS-DS) and (potentially) tracking progress towards individually-determined goals and plans. The app may also include activities that promote discussion between workers and service users as well as potential self-directed activities from the RAS-DS workbooks or other activities.

The app is designed to be used by mental health consumers along with their mental health workers, but guidance will be provided to individuals to connect with other mental health resources if needed.

Prompts / notifications may be built into the app depending on outcomes of the co-design workshops, but at a minimum the app will prompt individuals to complete the RAS-DS at least once every 6 months.

Adherence will be monitored via app analytics.

The Driv-R will be used collaboratively by the consumer and mental health worker as frequently as desired over a 6-month intervention period. Following the intervention period, participants in the "comparison group" will also be enabled to access the app and use it collaboratively between the mental health worker and the consumer / service user.

Participants in the intervention group will also be invited to participate in a post-trial qualitative interview. Qualitative interviews will be conducted with a sub-sample of participants (both consumers and workers) who interacted with Driv-R in the intervention phase. They will be selected through the purposive sampling strategy of maximum variation sampling, which ensures diversity of participants along relevant dimensions. In this case, interview participants will be selected to ensure variation based on data collected during the intervention phase, including mental health self-efficacy, frequency of Driv-R use, site, and satisfaction with Driv-R. As with much qualitative research, the appropriate number of participants will determined through the concept of ‘saturation’, where a rich understanding of relevant concepts has been achieved and additional interviews cease to yield additional categories and concepts. Based on our previous work, we estimate that this will be achieved by interviewing between 35 and 50 participants altogether.

Separate, informed consent will be sought and interviews will be audio recorded and transcribed verbaitm. It is estimated that interviews will take between 15 and 45 minutes, depending on how much each individual wishes to share.

Interviews will be conducted by a member of the interview team who has no existing relationship with the participant.
Intervention code [1] 326291 0
Behaviour
Comparator / control treatment
Treatment as usual. Treatment as usual consists of goal setting and treatment planning as well as active supports for mental health and social wellbeing. This may include community-based supports to engage in meaningful activities and attend mental health and general health services. Supports may include a range of activities, aligned to their person's mental health goals including employment, independent everyday living and social relationships.

Participants in the "comparison" group will be offered the Driv-R app to use following the completion of the intervention period in the intervention group (i.e., after 6 months).
Control group
Active

Outcomes
Primary outcome [1] 335044 0
Mental Health Self Efficacy (as measured by the Mental Health Confidence Scale)
Timepoint [1] 335044 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [1] 422827 0
Self-reported Mental Health Recovery (as measured by the Recovery Assessment Scale - Domains and Stages: overall / composite score)
Timepoint [1] 422827 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [2] 423392 0
Use, Feasibility and Helpfulness Questionnaire (questionnaire related to how the RAS-DS / Driv-R is used by mental health workers / service users and how these are used to plan goals for mental health recovery)
Timepoint [2] 423392 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Secondary outcome [3] 423393 0
Driv-R Support Needed Questionnaire
Timepoint [3] 423393 0
Baseline (0 months - after first use of Driv-R app)
Completion of intervention (6 months)
Secondary outcome [4] 423394 0
data analytics from Driv-R: uptake
Timepoint [4] 423394 0
During the intervention period (0 months to 6 months)
Secondary outcome [5] 423675 0
Self-management / control of mental illness symptoms (as measured by the Recovery Assessment Scale - Domains and Stages: 'Mastering my illness' Domain)
Timepoint [5] 423675 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [6] 423676 0
Participation in meaningful activities (as measured by Recovery Assessment Scale - Domains and Stages: 'Doing things I value' Domain)
Timepoint [6] 423676 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [7] 423677 0
Positivity and wellbeing (as measured by Recovery Assessment Scale - Domains and Stages: 'Looking forward' Domain)
Timepoint [7] 423677 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [8] 423678 0
Social participation (as measured by Recovery Assessment Scale - Domains and Stages: 'Connecting and blenonging' Domain)
Timepoint [8] 423678 0
Enrolment (-6 months)
Baseline / pre-intervention (0 months)
Completion of intervention (6 months)
Follow-up (12 months)
Secondary outcome [9] 423679 0
data analytics from Driv-R: use statistics
Timepoint [9] 423679 0
During the intervention period (0 months to 6 months)
Secondary outcome [10] 423680 0
data analytics from Driv-R: accessibility of the platform
Timepoint [10] 423680 0
During the intervention period (0 months to 6 months)

Eligibility
Key inclusion criteria
Current service users and mental health workers from participating mental health services and teams within those services.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria for mental health worker participants.
Exclusion criteria for consumer participants: (1) Insufficient reading comprehension in English to complete RAS-DS and/or questionnaires; (2) Acute episode of illness requiring in-patient care.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be completed using a 1 to 1 ratio between pairs of sites. Allocation will be via coinflip completed by a person external to the study.
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
The sample will be made up of staff-consumer dyads. We will be seeking to recruit a minimum of 200 and a maximum of 350 consumer/staff dyads across the 8 - 12 sites. As the specific effect size of the intervention is not known, these sample size calculations (using power of 0.8 and alpha value of 0.05) are based on a potential effect size of 0.3 to 0.5 and low intra-cluster correlations. The effect size of 0.3 is drawn from a meta-analysis of shared decision-making interventions (somewhat conceptually similar to this approach), and the effect size of 0.5 is based on the estimation that, given the Driv-R intervention is more directly focused on mental health self-efficacy and control, it is likely to have a more substantial impact than the interventions included in the meta-analysis. Sample size estimation was made using the GRT calculator from the National Institutes of Health (https://researchmethodsresources.nih.gov/grt-calculator).

Analyses are described below according to each of our research hypotheses:
Hypothesis 1: That Mental Health Self-Efficacy scores for the intervention group will show greater improvements than for the comparison group
An ANCOVA approach will be used to compare scores at the end of intervention between groups. End of intervention mental health self-efficacy scores will be the independent variable, “intervention” vs “comparison” group will be a fixed factor and baseline mental health self-efficacy score will be entered as a covariate.

Hypothesis 2: That participants using the Driv-R App will report higher ratings of usefulness and more control over decision making compared to comparison participants using the standard RAS-DS.
Scores for each item on the Use, Feasibility and Helpfulness Questionnaire from the baseline and end of intervention timepoints will be compared between groups using independent-samples t-tests. Qualitative information from interviews will also be used to explore user experiences of decision-making control and collaboration.

Hypothesis 3: That RAS-DS scores for the intervention group will show greater improvements than for the comparison group
An ANCOVA approach will be used to compare scores at the end of intervention between groups. End of intervention RAS-DS scores will be the independent variable, “intervention” vs “comparison” group will be a fixed factor and baseline mental health self-efficacy score will be entered as a covariate.

Hypothesis 4: That the Driv-R App will be easy to use and that consumers will be able to use it with decreasing levels of support over time (from both consumer and worker perspectives)
Scores from the “level of support required to use the App” questions (Support Needed Questionnaire) will be reported using descriptive statistics and will also be analysed for change over time. Scores from the baseline timepoint will be compared with scores from the end of intervention timepoint using paired t-tests. If the hypothesis is correct, then ratings for “support required” will decrease over time for the intervention group.

Hypothesis 5: That positive change in Mental Health Self-Efficacy and Mental Health Recovery will be sustained at follow up.
Repeated measures ANOVAs will be used to explore for differences between scores on the MHCS and RAS-DS from baseline, completion and follow-up timepoints. If the hypothesis is correct, then there will be significant increases from “baseline” to “follow-up” time-points and no significant deterioration in scores from “completion” to “follow-up” timepoint for the intervention group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/07/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
475
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 314049 0
Government body
Name [1] 314049 0
National Health and Medical Research Council
Country [1] 314049 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Risk and Governance Manager, Clinical Trials
Michael Spence Building
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 315951 0
None
Name [1] 315951 0
None
Address [1] 315951 0
None
Country [1] 315951 0
Other collaborator category [1] 282698 0
Commercial sector/Industry
Name [1] 282698 0
Flourish Australia
Address [1] 282698 0
Quad 3, Level 3, Suite 3.01,
102 Bennelong Parkway
Sydney Olympic Park NSW 2127
Country [1] 282698 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313185 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313185 0
Ethics committee country [1] 313185 0
Australia
Date submitted for ethics approval [1] 313185 0
24/03/2023
Approval date [1] 313185 0
28/06/2023
Ethics approval number [1] 313185 0
2023/325

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

Contacts
Principal investigator
Name 127274 0
A/Prof Justin Scanlan
Address 127274 0
Susan Wakil Health Building
Western Avenue
The University of Sydney, NSW, 2006
Country 127274 0
Australia
Phone 127274 0
+61 2 9351 9022
Fax 127274 0
Email 127274 0
justin.scanlan@sydney.edu.au
Contact person for public queries
Name 127275 0
Justin Scanlan
Address 127275 0
Susan Wakil Health Building
Western Avenue
The University of Sydney, NSW, 2006
Country 127275 0
Australia
Phone 127275 0
+61 2 9351 9022
Fax 127275 0
Email 127275 0
justin.scanlan@sydney.edu.au
Contact person for scientific queries
Name 127276 0
Justin Scanlan
Address 127276 0
Susan Wakil Health Building
Western Avenue
The University of Sydney, NSW, 2006
Country 127276 0
Australia
Phone 127276 0
+61 2 9351 9022
Fax 127276 0
Email 127276 0
justin.scanlan@sydney.edu.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19413Study protocol  justin.scanlan@sydney.edu.au
19414Informed consent form  justin.scanlan@sydney.edu.au
19415Ethical approval  justin.scanlan@sydney.edu.au



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.