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Trial registered on ANZCTR


Registration number
ACTRN12624000857505
Ethics application status
Approved
Date submitted
5/06/2024
Date registered
11/07/2024
Date last updated
16/07/2024
Date data sharing statement initially provided
11/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the Impact of a Digital Youth Mental Health Service (the EVOLVE study)
Scientific title
Evaluating the Impact of a Digital Youth Mental Health Service (the EVOLVE study): A pragmatic randomised controlled trial of a digital mental health service for youth with anxiety and depression.
Secondary ID [1] 312285 0
None
Universal Trial Number (UTN)
Trial acronym
EVOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety and Depression 334019 0
Condition category
Condition code
Mental Health 330689 330689 0 0
Anxiety
Mental Health 330690 330690 0 0
Depression
Public Health 330762 330762 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Moderated Online Social Therapy (MOST) is a digital mental health platform for young people aged between 12 and 25 years. MOST has been designed by experts in both digital mental health and in treatments for depression and anxiety in young people, along with input from young people and clinicians. MOST has 5 key components:

(1) Therapy content
(2) Online clinician support
(3) Online peer support
(4) Online work and study support
(5) A peer-led web-based community and social network

The content on MOST is comprised of journeys (The Fundamentals, Find Your Calm, Find Your Confidence, Social Hacks, Improve Your Sleep, Improve Your Mood) and tracks (essential content within the journeys, can include psychoeducation, activities and reflection). Descriptions of the journeys are as follows:

(1) The Fundamentals: This is a transdiagnostic therapy journey for young people experiencing mild-to-moderate depression and anxiety. Content in this journey covers emotional dysregulation, cognitive and affective biases, and avoidance.

(2) Find Your Calm: This journey focuses on generalised anxiety disorder. The content covers relaxation, worrying, problem-solving, avoidance, exposure, mindfulness, and self-compassion.

(3) Find Your Confidence: This journey targets social anxiety. The content focuses on cognitive reappraisal, identifying and tackling safety behaviours, addressing self-consciousness, perfectionism, and relationships.

(4) Social Hacks: This therapy journey relates to improving social functioning, in the context of early intervention in psychosis. The content covers amotivation, avolition, cognitive distortions, and improving social cognition.

(5) Improve Your Sleep: This journey focuses on insomnia and poor sleep. The content targets unhelpful beliefs about sleep, safety behaviours, provides strategies to improve sleep hygiene, and addressing barriers to behavioural change to improve sleep.

(6) Improve Your Mood: This journey relates to major depression. The content focuses on improving mindful awareness, tackling rumination, aversion, practising acceptance, and improving motivation.

During an intake call, collaborative treatment planning involves adopting a supported decision-making approach whereby clinicians integrate the young person's level of need, preferences, capacity and motivation in order to make a decision with the young person on the level of care offered on MOST.

There are five levels of care:

Option 1: Always available system of on demand supports. Young people will have on demand access to MOST support – without being enrolled in a structured clinical intervention. This system of support will include access to content, the peer-to-peer community, one-to-one vocational and peer support as needed (by phone and direct message), with monitoring for deterioration and risk via safety check and assessment functions embedded within MOST (based on onboarding presentation and ongoing activity on the platform). The Community is where MOST users can interact with each other. It's a social network where people can share their experiences with each other and offer support and advice. The community is also a space where MOST users share resources and tips on what they have found useful. Vocational and peer support will be provided by career consultants and peer workers respectively.

Option 2: Self-guided therapy Journey. Young people will have access to all supports available within Option 1 plus enrolment in a therapy journey without personalised clinician support (one of the six journeys outlined above). Young people can access the journey content at their own discretion. Journey content is based primarily on CBT fundamentals.

Option 3: Therapy Journey with clinician support (coaching). Young people will have access to everything available within Options 1 and 2, with the addition of weekly MOST clinician check-in sessions (via Zoom) to help personalise content, practice and apply skills, and troubleshoot stumbling blocks. There can be up to 6 weekly sessions, lasting 20 minutes (delivered via phone calls, and in some cases video call). The aim is to support a young person’s engagement with their journey, to build a young person’s understanding of psychoeducation within the track of the journey they are currently working on, to support and/or troubleshoot learning of new skills and translation into everyday life and to tailor the journey according to key therapeutic targets.

Option 4: Blended teletherapy. Young people will have access to everything available within Options 1 and 2. Young people will be offered up to 6 teletherapy sessions (delivered via Zoom) with a MOST clinician, blended with selected content aligned with the clinical formulation wherever appropriate. There can be up to 6 audio or video calls, up to 40 minutes in duration. The aim is to provide formulation-based, online modular therapy, integrated with MOST content personalised based on target mechanisms. A clinical formulation describes the predisposing, precipitating, perpetuating and protective factors with respect to the YP's key presenting problem. The formulation guides treatment planning by identifying therapy targets (i.e. perpetuating factors/mechanisms) that can be addressed using matched therapy content. For example, if rumination is a perpetuating problem for depression, the YP can be provided with content addressing the mechanism of rumination. The blended teletherapy level is a flexible and intensive approach to clinical support for those with higher needs whereby the clinician also continuously assesses the capacity of the YP for engagement with therapeutic content and will provide a realistic suggestion of the amount of content to complete during the week.

Option 5: Urgent care. Young people will receive a prioritised support call from a MOST clinician, followed by collaborative treatment planning. Referral into an appropriate higher intensity mental health service may be appropriate in many of these cases. This decision will be at the discretion of the clinician and based on a risk assessment. In contrast to the other, structured care plan options, for urgent care, support calls vary in duration depending on the severity and acuity of need. Young people may be referred to a range of higher intensity mental health services, including state-based specialist services, triage lines, suicide risk lines, depending on the situation.

Initial level of care for young people will be determined by their presentation at onboarding on to the MOST, where standardised youth mental health questions are administered. Young people will be invited to complete a brief check in assessment every 6 weeks of active engagement on MOST. Those young people showing a deterioration in their mental health are supported to “step up” to a higher level of care via a clinician call. This measurement-informed care process will allow the MOST service to stay with young people over time and adapt with them as clinical needs change. The total duration of active engagement in the study will be 12 weeks.
Intervention code [1] 328750 0
Treatment: Other
Comparator / control treatment
Treatment as usual- The control group will not receive the MOST intervention and may or may not be receiving external mental health support (including GP, psychologist, psychiatrist, case manager, counsellor, mental health worker, social worker, occupational therapist, family therapists, peer workers).
Control group
Active

Outcomes
Primary outcome [1] 338444 0
Anxiety and depression (assessed as a composite measure)
Timepoint [1] 338444 0
Week 12 post-baseline
Secondary outcome [1] 435962 0
Cost-effectiveness
Timepoint [1] 435962 0
Week 12 post-baseline
Secondary outcome [2] 435963 0
Psychological distress
Timepoint [2] 435963 0
Week 12 post-baseline
Secondary outcome [3] 435964 0
Functioning
Timepoint [3] 435964 0
Week 12 post-baseline
Secondary outcome [4] 435965 0
Mental Wellbeing
Timepoint [4] 435965 0
Week 12 post-baseline
Secondary outcome [5] 435967 0
Therapeutic alliance with the clinicians (assessed as a composite measure)
Timepoint [5] 435967 0
Week 12 post-baseline
Secondary outcome [6] 435968 0
User experience and feedback from young people and clinicians
Timepoint [6] 435968 0
Week 12 post-baseline

Eligibility
Key inclusion criteria
• Be aged between 15 and 25 years, inclusive.
• Have self-reported difficulties of anxiety and/or depression in the clinical range (3+ on the Patient Health Questionnaire-4).
• Have personal and private access to a computer, smartphone or tablet.
• Ability and willingness to nominate an emergency contact person, such as a close family member.
• Be willing to undergo online treatment over 12 weeks and complete questionnaires.
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Are outside the stated age range.
• Present with acute psychotic or manic illness.
• Present with acute suicidal behaviour or imminent risk of harm to self.
• Intellectual disability.
• Are unable to converse in or read English (English does not have to be the participant’s primary language).
• Are unable or unwilling to provide emergency contact details or unwillingness to engage in safety planning and crisis support.
• Prior exposure to MOST or associated trials.

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)
Yes - central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) - stratified by symptom severity (as measured by the PHQ-ADS) and external service use (as measured by the RUQ).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA

Funding & Sponsors
Funding source category [1] 316673 0
Government body
Name [1] 316673 0
National Health and Medical Research Council (NHMRC)
Country [1] 316673 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Orygen
Address
Country
Australia
Secondary sponsor category [1] 318861 0
University
Name [1] 318861 0
University of Melbourne
Address [1] 318861 0
Country [1] 318861 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315451 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315451 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 315451 0
Australia
Date submitted for ethics approval [1] 315451 0
31/05/2024
Approval date [1] 315451 0
19/06/2024
Ethics approval number [1] 315451 0
2024-29304-54174-2

Summary
Brief summary
To date, Moderated Online Social Therapy (MOST) has only been trialled in clinical research settings with referrals from clinical services. The Evaluating the Impact of a Digital Youth Mental Health Service study: A pragmatic randomised controlled trial of a digital mental health service for youth with anxiety and depression (EVOLVE), seeks to extend upon previous feasibility, acceptability, and efficacy research in these settings by testing the effectiveness and cost-effectiveness of MOST in a real-world, community sample. Evolve is a prospective, parallel two-group, CONSORT-R compliant, superiority RCT. Young people in the general community aged 15-25 years, with self-reported anxiety and depression symptoms, will be recruited through a targeted social media campaign.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134746 0
Prof Mario Alvarez-Jimenez
Address 134746 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 134746 0
Australia
Phone 134746 0
+61 3 9966 9383
Fax 134746 0
Email 134746 0
[email protected]
Contact person for public queries
Name 134747 0
Dr Eleanor Carey
Address 134747 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 134747 0
Australia
Phone 134747 0
+61 487020094
Fax 134747 0
Email 134747 0
[email protected]
Contact person for scientific queries
Name 134748 0
Dr Eleanor Carey
Address 134748 0
Orygen Youth Health, 35 Poplar Rd, Parkville VIC 3052
Country 134748 0
Australia
Phone 134748 0
+61 487020094
Fax 134748 0
Email 134748 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?
De-identified, individual data for research purposes (eg meta-analyses)
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Contact Principal Investigator Mario Alvarez-Jimenez at [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.