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Trial registered on ANZCTR


Registration number
ACTRN12620000113954
Ethics application status
Approved
Date submitted
17/01/2020
Date registered
7/02/2020
Date last updated
7/02/2020
Date data sharing statement initially provided
7/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Mind - Testing if an Online Tool Can Help People with Borderline to-Mild Intellectual Disability Improve Their Mental Health
Scientific title
Healthy Mind - A Randomised Controlled Trial of an Online Mental Health Tool for People with Borderline to-Mild Intellectual Disability
Secondary ID [1] 300291 0
None
Universal Trial Number (UTN)
U1111-1246-8120
Trial acronym
IDTWO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intellectual Disability 315877 0
Depression 315878 0
Anxiety 315879 0
Condition category
Condition code
Mental Health 314157 314157 0 0
Other mental health disorders
Mental Health 314280 314280 0 0
Depression
Mental Health 314281 314281 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Mind is an Easyread, fully automated, fully online cognitive behaviour therapy (CBT) program developed by the Black Dog Institute. Healthy Mind comprises 5 CBT modules: (1) Recognising Feelings helps users label and communicate their emotions; (2) Breathe and Relax teaches uses controlled breathing techniques to regulate sympathetic arousal; (3) Taming Anger helps users identify ager and employ calming strategies; (4) Having More Fun helps users plan enjoyable activities into their weekly schedule; and (5) Tackling Unhelpful Thinking helps users re-evaluate distressing thoughts. Each module takes approximately 10 minutes to complete and involves watching a video and/or reading a story, and completing a guided practical exercise related to the video or story (e.g. practising controlled breathing). Study participants in the treatment condition will have open access to Healthy Mind for a period of 8 weeks, during which time all modules will be available and can be completed in any order. Participants must use the intervention at least once during their 8-week period but are free to use the intervention as often as they like in any way they choose. They will be able to use the program independently or with a trusted carer on any internet connected device.
Intervention code [1] 316565 0
Behaviour
Comparator / control treatment
Waitlist control. Participants will have no access to the active treatment for a period of 8 weeks. No restrictions will be placed on accessing any other care during the waitlist period.
Control group
Active

Outcomes
Primary outcome [1] 322543 0
Anxiety Depression and Mood Scale (ADAMS)
Timepoint [1] 322543 0
Immediate prior to treatment; immediately after completing the treatment phase (i.e. 8 weeks after Time 1); and again 3-months after completing treatment (i.e. 3-month after Time 2).
Secondary outcome [1] 378886 0
Kessler 10
Timepoint [1] 378886 0
Immediate prior to treatment; immediately after completing the treatment phase (i.e. 8 weeks after Time 1); and again 3-months after completing treatment (i.e. 3-month after Time 2).
Secondary outcome [2] 378887 0
WHO-DAS 2
Timepoint [2] 378887 0
Immediate prior to treatment; immediately after completing the treatment phase (i.e. 8 weeks after Time 1); and again 3-months after completing treatment (i.e. 3-month after Time 2).

Eligibility
Key inclusion criteria
- Are an Australian resident aged 16 years or over.
- Have a previous diagnosis of a borderline-to-mild ID (diagnosis of borderline-to-mild ID will be confirmed by the nominated carer, and an estimate of cognitive functioning will be obtained prior to commencement of the trial using Cambridge Brain Science online assessment platform.
- Report mild-to-moderate symptoms of depression and/or anxiety.
- Can nominate a “study helper” to assist them throughout trial participation (Each study participant will nominate a trusted carer to provide support throughout all trial stages. A study helper may be a carer, support-worker, family member, friend or other trusted individual. Consent, screening and all other data collection will be completed online with study helper support).
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Report ID severity greater than mild.
- Report severe mental health problems (severe symptoms of anxiety and/or depression, severe mood disturbance and/or mania, suicidal ideation, psychotic symptoms).
- Are experiencing medical comorbidities or other functional impairments that might impede trial engagement (e.g. impaired vision, hearing, motor skills etc.).
- Are not an Australian resident.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised using computerised random number generation at a 1:1 ratio. The randomisation process is completed automatically by the trial management software (BDI Research Engine) and cannot be adjusted by investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Automated block randomisation at 1:1 ratio
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
Statistical analyses will be performed using IBM SPSS and MPlus. Intention-to-treat analyses will be used to establish change across time and any treatment effects using linear mixed models for repeated measures (MMRM). Missing data will be handled using maximum likelihood estimation within the MMRM procedure, as this appears to be more robust to violations of the assumption of randomness due to attrition. Complier analyses will be used to estimate the effect of treatment-as-recommended using a Complier Average Causal Effect (CACE). FSIQ and cognitive sub-domains (e.g. speed of information processing) will be used in all analyses to determine if cognitive ability moderates effects of or engagement with Healthy Mind.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304715 0
Charities/Societies/Foundations
Name [1] 304715 0
Australian Rotary Health
Address [1] 304715 0
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150
Country [1] 304715 0
Australia
Primary sponsor type
Individual
Name
Dr Peter Baldwin
Address
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 305029 0
Charities/Societies/Foundations
Name [1] 305029 0
Black Dog Institute
Address [1] 305029 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country [1] 305029 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305139 0
UNSW HREC
Ethics committee address [1] 305139 0
UNSW
High Street
Randwick NSW 2031
Ethics committee country [1] 305139 0
Australia
Date submitted for ethics approval [1] 305139 0
10/06/2019
Approval date [1] 305139 0
12/08/2019
Ethics approval number [1] 305139 0
HC190393

Summary
Brief summary
Substantial evidence tells us that people with intellectual disability (ID) urgently need accessible and affordable mental healthcare options. Despite electronic mental health (eMH) making mental health more affordable and accessible, Australians with ID cannot access the eMH programs that their peers now take for granted. A specifically designed eMH tool has the potential to close this gap and place crucial mental health services in the hands of thousands of Australians with borderline-to-mild ID. To our knowledge, our purpose-designed eMH health tool (named Healthy Mind) is the first program of its kind designed by and for people with ID. Healthy Mind is the product of considerable research, clinical and life expertise gathered across many individuals and organisations. Our tool is designed to target the most commonly experienced symptoms of psychological distress in people with ID. It is based on empirically effective strategies that have been demonstrated to improve anxiety and depression in previous trials involving people with ID.

This project aims to establish if Healthy Mind can help Australians (16yo and over) with borderline-to-mild ID reduce symptoms of anxiety and depression and improve their day-to-day functioning. A secondary aim of this project is to determine if Healthy Mind can help support the mental health of younger Australians with borderline-to-mild ID as they experience a stressful life transition, such as moving into a more independent living arrangement or commencing employment. We hope that individuals who use Healthy Mind will experience reduced anxiety and depression, and increased daily functioning, when compared with individuals in a control group. We also hope that individuals who use Healthy Mind while undertaking a stressful life transition will report better coping and lower stress in response to their life transition than similar individuals in a control condition.

The potential benefits of a program like Healthy Mind are wide-ranging. With improved access to mental healthcare, people with ID and their families will likely require fewer support services, experience fewer carer days-out-of-role and increased levels of community participation, including greater employment. Additionally, the specialised nature of Healthy Mind appears to help users feel empowered and included. Initial user testing has revealed not only the feasibility and acceptability of Healthy Mind, but also excitement and gratitude for an eMH program designed by and for people with ID.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99374 0
Dr Peter Baldwin
Address 99374 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 99374 0
Australia
Phone 99374 0
+61 2 9382 4530
Fax 99374 0
Email 99374 0
p.baldwin@unsw.edu.au
Contact person for public queries
Name 99375 0
Dr Peter Baldwin
Address 99375 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 99375 0
Australia
Phone 99375 0
+61 2 9382 4530
Fax 99375 0
Email 99375 0
p.baldwin@unsw.edu.au
Contact person for scientific queries
Name 99376 0
Dr Peter Baldwin
Address 99376 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 99376 0
Australia
Phone 99376 0
+61 2 9382 4530
Fax 99376 0
Email 99376 0
p.baldwin@unsw.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
We do not yet have permission for this but it is under consideration
What supporting documents are/will be available?
No other documents available
Summary results
No Results