Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000864527
Ethics application status
Approved
Date submitted
24/06/2024
Date registered
12/07/2024
Date last updated
12/07/2024
Date data sharing statement initially provided
12/07/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development of a website for family/friends of adults with depression
Scientific title
Evaluating the acceptability, usability, usefulness of, and engagement with Depression Assist, a psychoeducation website for close family/friends of adults with major depressive disorder
Secondary ID [1] 312347 0
None
Universal Trial Number (UTN)
Trial acronym
DepressionASSIST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carer mental health 334118 0
Depression 334119 0
Condition category
Condition code
Mental Health 330793 330793 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 330964 330964 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants can access the DepressionASSIST website (described below) for 3 months after their initial access. Participants complete a survey that helps them to develop a pathway through the intervention based on their goals and what is relevant to them, however, they can complete the modules at their own discretion. Engagement with the site will be enhanced by monthly telehealth sessions, via telephone or zoom, where a facilitator will help the participant navigate the site and understand the content. Facilitatiors are trained by accredited psychologists two weeks prior to the start of the intervention for a total of 5 hours and supervised weekly by a psychologist throughout the intervention. The sessions will take approximately 40 to 60 minutes and the participant will provide feedback on their experience using the site during these sessions. Participants will also complete monthly 10 minute online surveys to monitor their depressive symptoms (using the Depression, Anxiety, and Stress Scales, 21 item version and item 9 from the self-report version of the Montogomery Åsberg Rating Scale), as well as wellbeing and coping measures (Carer-related Quality of Life Instrument, Brief Coping Orientation to Problems Experienced Inventory, World Health Organisation-Five Well-Being Index). Adherence will be monitored using session attendance, survey completion, and monitoring of website use over the three months. Data on how participants used the website will also be gathered (e.g., what they have accessed, how long they interacted with it) and compared with the initial intervention pathway they developed.

The DepressionASSIST website:
The DepressionASSIST program includes access to a psychoeducation website containing information that may be important for family/friends of people with major depressive disorder to know, based on the results of a Delphi study in combination with the latest literature. This information is presented as 7 interactive modules: Maintaining Wellbeing, What is Depression, Causes and Triggers, Treatment and Coping Strategies, Providing Support, Helping in a Crisis, and Relationships and Communication. Each module is augmented with interactive tools to help users learn and apply the information. These “care tools” are simple editable forms with suggestions derived from website content, space for personalized responses and hypothetical examples for family/friends to practice skills prior to applying them to their situation. The care tools include reflection tools to help family/friends step back and monitor their own stress/depression and ways of coping as well as the person’s depressive symptoms, coping tools including stress reduction and problem-solving exercises and plans for helping the person they support in an acute episode, with suicide risk, and to prevent relapse, and decision tools to encourage the use of helpful coping skills and support services. These tools are based on effective face-to-face family and carer psychoeducation interventions and evidenced-based techniques for reducing stress and anxiety and depressive symptoms from Cognitive Behavioural Therapy, Acceptance, Mindfulness approaches and Acceptance and Commitment Therapy. These tools have been developed specifically for this study and are not readily available resources.
Intervention code [1] 328839 0
Prevention
Intervention code [2] 328984 0
Lifestyle
Intervention code [3] 328985 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338561 0
Acceptability of the DepressionASSIST website.
Timepoint [1] 338561 0
Four, 8, and 12 weeks following initial access to DepressionASSIST website.
Primary outcome [2] 338729 0
Usability of the DepressionASSIST website
Timepoint [2] 338729 0
Four, 8, and 12 weeks following initial access to DepressionASSIST website and throughout the three-month trial.
Primary outcome [3] 338730 0
Usefulness of the DepressionASSIST website
Timepoint [3] 338730 0
Four, 8, and 12 weeks following initial access to DepressionASSIST website.
Secondary outcome [1] 436439 0
Wellbeing
Timepoint [1] 436439 0
Baseline, 4, 8, and 12 weeks following initial access to DepressionASSIST website.
Secondary outcome [2] 436440 0
Quality of life
Timepoint [2] 436440 0
Baseline, 4, 8, and 12 weeks following initial access to DepressionASSIST website.
Secondary outcome [3] 436441 0
Coping styles
Timepoint [3] 436441 0
Baseline, 4, 8, and 12 weeks following initial access to DepressionASSIST website.
Secondary outcome [4] 437222 0
Engagement with the DepressionASSIST website - primary outcome
Timepoint [4] 437222 0
Four, 8, and 12 weeks following initial access to DepressionASSIST website.
Secondary outcome [5] 437494 0
Safety of the DepressionASSIST program. Please note we have a risk management and adverse events standard operating procedure to reduce, report and mitigate safety issues.
Timepoint [5] 437494 0
Assessed monthly (baseline, weeks 4, 8, 12) through survey and facilitation session and in response to participant contact at any stage.

Eligibility
Key inclusion criteria
All participants will need to
• Identify as a key informal support person, and family member, friend or partner of an adult (18 or over) with a primary diagnoses of major depressive disorder (i.e. The MDD is not secondary to a serious medical illness or alcohol or other drug problem as this would also require specialized information on these other conditions).
• Be aged 18 years or over.
• Be able to speak and read English at a sufficient level to understand website content and respond to the surveys.
• Live in Australia, as this version of the website will provide information specific to Australian health, social and legal services and policies and phone contact. Later it may be possible to adapt this website to include services and resources in other countries.
• Be able to access the website on their computer via the Internet and be contactable via email and phone.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Having a physical or neurological disorder that will impair their ability to participate fully (e.g. Dementia).
• The person they care for is currently diagnosed with bipolar disorder.
• Currently severely depressed as evidenced by a score of 21 or higher on the Depression Scale of the Depression, Anxiety and Stress Scale.
• Currently suicidal as indicated by a score of greater than or equal to 2 on item 9 of the Montgomery and Asberg Rating Scale self-assessment version.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 316749 0
Government body
Name [1] 316749 0
Barwon Health
Country [1] 316749 0
Australia
Funding source category [2] 316752 0
Charities/Societies/Foundations
Name [2] 316752 0
Australasian Society for Bipolar & Depressive Disorders
Country [2] 316752 0
Australia
Funding source category [3] 316753 0
Commercial sector/Industry
Name [3] 316753 0
GMHBA
Country [3] 316753 0
Australia
Funding source category [4] 316754 0
Charities/Societies/Foundations
Name [4] 316754 0
National Service Scholarship Foundation
Country [4] 316754 0
Australia
Funding source category [5] 316755 0
University
Name [5] 316755 0
Deakin University
Country [5] 316755 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 319024 0
None
Name [1] 319024 0
None
Address [1] 319024 0
Country [1] 319024 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315522 0
Barwon Health HREC
Ethics committee address [1] 315522 0
Ethics committee country [1] 315522 0
Australia
Date submitted for ethics approval [1] 315522 0
01/03/2018
Approval date [1] 315522 0
09/04/2018
Ethics approval number [1] 315522 0
17/192
Ethics committee name [2] 315524 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [2] 315524 0
Ethics committee country [2] 315524 0
Australia
Date submitted for ethics approval [2] 315524 0
Approval date [2] 315524 0
Ethics approval number [2] 315524 0

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

Contacts
Principal investigator
Name 134958 0
Dr Lesley Berk
Address 134958 0
Health Education and Research Building (HERB) Level 3, Barwon Health, P.O. Box 281 Geelong VIC 3220
Country 134958 0
Australia
Phone 134958 0
+61 3 52479338
Fax 134958 0
Email 134958 0
[email protected]
Contact person for public queries
Name 134959 0
Dr Josie O'Donohue
Address 134959 0
Health Education and Research Building (HERB) Level 3, Barwon Health, P.O. Box 281 Geelong VIC 3220
Country 134959 0
Australia
Phone 134959 0
+61 3 522 78507
Fax 134959 0
Email 134959 0
[email protected]
Contact person for scientific queries
Name 134960 0
Dr Josie O'Donohue
Address 134960 0
Health Education and Research Building (HERB) Level 3, Barwon Health, P.O. Box 281 Geelong VIC 3220
Country 134960 0
Australia
Phone 134960 0
+61 3 522 78507
Fax 134960 0
Email 134960 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
• Participant data supporting the publication results
• Participant data relating to primary outcomes
Note: All data will be de-identified.
When will data be available (start and end dates)?
Data will be available 3 months after publication.
Data will be available for an indefinite time.
Start date: Approximately 2025 – 2026.
End date: Unknown
Available to whom?
Data are potentially available to researchers on a case-by-case basis. All data requests will be considered by the principal investigator on a case-by-case basis and must be approved by the Sponsors. Requests must include a methodologically sound proposal and data analysis plan. Specific conditions of use may apply and will be specified in a data agreement that the requester must first agree to.
Available for what types of analyses?
Assessed on a case-by-case basis.
How or where can data be obtained?
Initial requests can be made to the Principle Investigator (Dr Lesley Berk, [email protected]).


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.