Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001203448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
26/09/2025
Date registered
Help: Date registered
31/10/2025
Date last updated
Help: Date last updated
31/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
31/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
ClearlyMe Blended Care: Evaluating the acceptability and feasibility of a blended care approach for adolescent depression.
Scientific title
ClearlyMe Blended Care: Evaluating the acceptability and feasibility of a blended care approach for adolescent depression.
Additional trial identifiers [1] 315463 0
Nil
Universal Trial Number (UTN)
U1111-1329-1151
Trial acronym
CMBC Pilot
Related trial records

Health condition
Health condition(s) studied:
Depression 339028 0
Condition category
Condition code
Mental Health 335314 335314 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
ClearlyMe is a self-guided, smartphone application developed by the Black Dog Institute for adolescents with mild to moderate depression. ClearlyMe comprises 37 brief (5–10 minute), non-sequential activities that target key symptoms of depression, including low mood, negative automatic thoughts, and reduced motivation. It is based on a gold-standard CBT approach to treating depression, with the activities incorporating key CBT components including psychoeducation, cognitive restructuring, goal setting, and activity scheduling.

Example activities include;
• “5, 4, 3, 2, 1 – Grounded” – A grounding activity to help settle intense emotions.
• “Question your thoughts” – A thought challenging exercise to reframe negative thoughts.
• “Setting goals” – Short term goal setting activity.
• “Get moving” – Behavioural activation activity.
• “What is mindfulness” – Psyhoeducation about mindfulness and an audio gui
• “Sleep better” – A guided meditation for use at bed time.

This trial will evaluate the acceptability and feasibility to clinicians of a newly developed digital platform, ClearlyMe Blended Care (CMBC). The platform was designed to support clinicians in private practice or related settings who are delivering cognitive behavioural therapy (CBT) to adolescent clients experiencing symptoms of depression, by allowing them to prescribe (and their clients to complete) activities from the ClearlyMe intervention.

For the purposes of this pilot trial, all 37 ClearlyMe activities will be recreated in a web-based platform (ClearlyMe Blended Care). Participating clinicians will be granted access to the platform and will be able to invite their clients to access ClearlyMe content via the platform where they deem it clinically appropriate.

On enrolment in the study, participating clinicians will complete a brief (~1h) online training module that provides an orientation to the CMBC platform and high-level guidance on how ClearlyMe content might be used to support therapy. These training resources will remain accessible to participating clinicians throughout the trial.

Participants (i.e. clinicians) will have access to the CMBC platform for a period of four months in which they can register their clients to access prescribed content. Following this four month period, clinicians will retain access to the platform to use with previously registered clients until completion of their treatment, however they will be unable to register new clients.

Clinicians will have complete discretion over which activities and how many activities they prescribe to their clients, and these activities will complement (not replace) in-person delivery of therapy. Participation in this trial places no restrictions on the frequency or duration of in-person sessions. Clinicians will retain complete autonomy as to how they choose to provide treatment to their clients, whether they choose to use CMBC activities with their clients, and how they choose to integrate these activities alongside standard care.

The platform will automatically collect data on the number of clients registered, which activities were prescribed and completed, and which training resources were accessed.
Intervention code [1] 332085 0
Treatment: Other
Intervention code [2] 332289 0
Behaviour
Description of the comparator or control
Nil. This is a single arm pilot.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342898 0
Clinician acceptability
Timepoint [1] 342898 0
4 months post baseline and completion of training
Primary outcome [2] 343161 0
Clinician acceptability
Timepoint [2] 343161 0
4 months post baseline and completion of training
Primary outcome [3] 343162 0
Clinician acceptability
Timepoint [3] 343162 0
4 months post baseline and completion of training
Secondary outcome [1] 452635 0
Feasibility
Timepoint [1] 452635 0
4 months post baseline and completion of training
Secondary outcome [2] 453558 0
Feasibility
Timepoint [2] 453558 0
4 months post baseline and completion of training
Secondary outcome [3] 453559 0
Feasibility
Timepoint [3] 453559 0
4 months post baseline and completion of training

Eligibility
Key inclusion criteria
(1) Registered psychologist.
(2) Currently working in private practice or a similar setting (e.g. headspace centres) in Australia.
(3) Current caseload includes at least two adolescents.
(4) Fluent in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Nil exclusion criteria other than not meeting the inclusion criteria.

Study design
Purpose of the study
Treatment
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
Safety
Statistical methods / analysis
The aim is to enrol between 25 and 50 psychologists to participate in this study. This sample is adequate to address the research questions as the aim is to explore the acceptability and feasibility of using ClearlyMe content to support in-person therapy from the perspective of clinicians - not clinical efficacy. This sample size is consistent with previous blended care pilots (1-3).

Quantitative outcome measures will be analysed using repeated-measures analyses (e.g., linear mixed effects models), to account for within-subject changes across time points (baseline, mid, post). Clustering based on clinical practice will be accounted for. These models allow for inclusion of participants with partial data and are robust to missingness under a Missing at Random assumption.

Where appropriate, paired t-tests or Wilcoxon signed-rank tests will be used for exploratory comparisons between specific time points. Group-level mean changes over time will be presented alongside 95% confidence intervals and effect size estimates (where appropriate).
Exploratory analyses may also examine associations between clinician characteristics (e.g., years of experience, digital literacy) and outcomes using correlation and regression models.

Interviews will be professionally transcribed. Two researchers will independently code transcripts. A content analysis approach will be taken to identify salient themes, principles and ideas. Themes will be developed deductively, and interpretation will be situated within the broader study aims.

1. Kooistra L, Ruwaard J, Wiersma J, van Oppen P, Riper H. (2020). Working alliance in blended versus face-to-face cognitive behavioral treatment for patients with depression in specialized mental health care. Clinical Medicine, 9(2), 319.
2. Lungu A, Jun JJ, Azarmanesh O, Leykin Y, Chen CE. (2020). Blended care–cognitive behavioral therapy for depression and anxiety in real-world settings: Pragmatic retrospective study. Journal of Medical Internet Research, 22(7), e18723.
3. O'Sullivan S, McEnery C, Cagliarini D, Hinton JDX, Valentine L, Nicholas J, Chen NA, Castagnini E, Lester J, Kanellopoulos E, D'Alfonso S, Gleeson JF,Alvarez-Jimenez M. (2024). A novel blended transdiagnostic intervention (eOrygen) for youth psychosis and borderline personality disorder: Uncontrolled single-group pilot study. JMIR Mental Health, 11, e49217.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 320056 0
Charities/Societies/Foundations
Name [1] 320056 0
Goodman Foundation
Country [1] 320056 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 322607 0
None
Name [1] 322607 0
N/A
Address [1] 322607 0
Country [1] 322607 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318600 0
The University of New South Wales Committee C
Ethics committee address [1] 318600 0
Ethics committee country [1] 318600 0
Australia
Date submitted for ethics approval [1] 318600 0
04/08/2025
Approval date [1] 318600 0
15/09/2025
Ethics approval number [1] 318600 0
iRECS9516

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

Contacts
Principal investigator
Name 144674 0
A/Prof Aliza Werner-Seidler
Address 144674 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 144674 0
Australia
Phone 144674 0
+61 412 657 812
Fax 144674 0
Email 144674 0
[email protected]
Contact person for public queries
Name 144675 0
Adam Theobald
Address 144675 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 144675 0
Australia
Phone 144675 0
+61 290659038
Fax 144675 0
Email 144675 0
[email protected]
Contact person for scientific queries
Name 144676 0
Adam Theobald
Address 144676 0
Black Dog Institute, Hospital Rd, Randwick NSW 2018
Country 144676 0
Australia
Phone 144676 0
+61 290659038
Fax 144676 0
Email 144676 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Please contact the data custodian A/Prof Aliza Werner-Seidler - [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.