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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

29/06/2021

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]

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

Depression

Anxiety

Condition category

Condition code

Mental Health

Other mental health disorders

Mental Health

Depression

Mental Health

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]

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]

Anxiety Depression and Mood Scale (ADAMS)

Timepoint [1]

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]

Kessler 10

Timepoint [1]

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]

WHO-DAS 2

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Recruiting

Date of first participant enrolment

Anticipated

15/03/2020

Actual

16/03/2020

Date of last participant enrolment

Anticipated

30/06/2021

Actual

Date of last data collection

Anticipated

31/08/2021

Actual

Sample size

Target

150

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Address [1]

2nd Floor, 43 Hunter Street,
Parramatta NSW 2150

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Peter Baldwin

Address

Black Dog Institute
Hospital Road
Randwick NSW 2031

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Black Dog Institute

Address [1]

Black Dog Institute
Hospital Road
Randwick NSW 2031

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW HREC

Ethics committee address [1]

UNSW
High Street
Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/06/2019

Approval date [1]

12/08/2019

Ethics approval number [1]

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

Dr Peter Baldwin

Address

Black Dog Institute
Hospital Road
Randwick NSW 2031

Country

Australia

Phone

+61 2 9382 4530

Fax

[email protected]

Contact person for public queries

Name

Peter Baldwin

Address

Black Dog Institute
Hospital Road
Randwick NSW 2031

Country

Australia

Phone

+61 2 9382 4530

Fax

[email protected]

Contact person for scientific queries

Name

Peter Baldwin

Address

Black Dog Institute
Hospital Road
Randwick NSW 2031

Country

Australia

Phone

+61 2 9382 4530

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Idtwo: A protocol for a randomised controlled trial of a web-based mental health intervention for australians with intellectual disability.	2021	https://dx.doi.org/10.3390/ijerph18052473

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically