Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000378820
Ethics application status
Approved
Date submitted
6/02/2021
Date registered
1/04/2021
Date last updated
1/04/2021
Date data sharing statement initially provided
1/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating a digital mental health screening tool for youth into primary care
Scientific title
A cluster-randomised, parallel two-arm, controlled implementation and effectiveness trial of an adolescent digital mental health screening and treatment recommendation service for use in general practices
Secondary ID [1] 303369 0
None
Universal Trial Number (UTN)
U1111-1264-6603
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
depression 320633 0
anxiety 320634 0
Condition category
Condition code
Mental Health 318489 318489 0 0
Depression
Mental Health 318490 318490 0 0
Anxiety
Public Health 318491 318491 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two interventions are being evaluated in this study:
1) A digital mental health screening and treatment-recommendation tool for adolescent patients attending general practice (‘Youth StepCare’)
2) An interactive, online implementation toolkit (‘ItFits Toolkit’) informed by Normative Process Theory, designed to facilitate integration of digital mental health tools into primary mental health care.

DIGITAL MENTAL HEALTH SCREENING TOOL: YOUTH STEPCARE
Developed by the Black Dog Institute, Youth StepCare is a digital mental health screening, treatment-recommendation, and symptom monitoring tool that aims to (a) improve the early detection and management of common mental health conditions in young patients (aged 15-17) attending general practices, and (b) facilitate greater uptake of digital mental health interventions in primary mental health care. Youth StepCare screens youth patients for depression and anxiety in the practice waiting area, and then provides general practitioners (GPs) with treatment recommendations based on the principles of stepped-care, with digital mental health interventions integrated into the treatment recommendations.

The Youth StepCare tool is used as follows:

1. Registration and screening. Upon arrival to a participating general practice, youth patients aged 15-17 will be provided with a study information sheet and QR code by practice staff. The patient will be invited to sit in the waiting room and read information sheet. If the patient wishes to participate, they will then scan the QR code with their personal mobile device, which will direct them to the Youth StepCare landing page. Here, they will choose their GP from a drop-down box and confirm their age. They will subsequently demonstrate their capacity to provide informed consent (using the Gillick Competency Assessment), provide consent to participate in the trial, and will then register using a valid email address. Patients can also register a mobile phone number and indicate which mode of communication they prefer (email or SMS). These details will be used to send symptomatic patients mental health screening measures fortnightly.

Participants will register their name and gender and then be asked two questions to determine whether they are attending their appointment for mental health reasons, or whether they have previously seen a doctor for mental health reasons. Next, they will be asked to answer questions about their mental health, including symptoms of anxiety, depression, and suicidal thinking. These are measured using validated psychometric questionnaires including the seven-item Generalised Anxiety Disorder Scale (GAD-7) and the nine-item Patient Health Questionnaire for depression (PHQ-9). Patients will receive immediate brief feedback on their screen before discussing their mental wellbeing further during their doctor’s appointment.

2. Treatment recommendation. Once a patient has completed their screening survey, a treatment recommendation report is generated and transmitted to the GP’s medical inbox. This treatment recommendation report first determines the patient’s overall symptom severity (nil/minimal, mild, moderate, severe) and then provides treatment recommendations that are matched to the patient’s symptom severity.

Symptom severity is determined using empirically-defined cut-offs on the PHQ-9 and GAD-7, with the highest scoring scale determining the severity level:
• Nil/minimal: PHQ-9 AND GAD-7 score 0-4
• Mild: PHQ-9 score 5-9 OR GAD-7 score 5-9
• Moderate: PHQ-9 score 10-19 OR GAD-7 score 10-14
• Severe: PHQ-9 score 20-27 OR GAD-7 score 15-21

The treatments recommended for each severity level are as follows:
• Nil/minimal: No treatment
• Mild: digital mental health intervention (Smooth Sailing program)
• Moderate: digital mental health intervention (Smooth Sailing) AND referral to a Psychologist or local CAMHS team for psychological therapy. If psychological therapy not wanted or inappropriate, consider referral to a Child and Adolescent Psychiatrist for pharmacological treatment.
• Severe: digital mental health intervention (Smooth Sailing) AND referral to a Psychologist or local CAMHS team for psychological therapy AND referral to a Child and Adolescent Psychiatrist for pharmacological treatment.

Smooth sailing is a self-guided web-based psychoeducation program designed to help adolescents manage depression and anxiety. It provides adolescents with information about mental health, help-seeking, and where appropriate, self-directed online Cognitive Behavioural Therapy (CBT). It consists of six modules: mental health literacy; anxiety; depression; help-seeking for oneself; help-seeking for a friend; self-guided CBT. Smooth Sailing is integrated into Youth StepCare allowing GPs to recommend the program with a simple click.

3. GP Consultation and treatment plan. During the consultation, GPs are advised to discuss the mental health screening results with their patient and determine an appropriate treatment plan. GPs are asked to record the treatment plan provided to patients via a link accessed in the report.

4. Symptom monitoring. Patients who report mild, moderate, or severe mental health symptoms at the time of screening will be monitored every two weeks for 12-weeks to track symptom improvement. During fortnightly monitoring, patients will be sent a link via email or SMS to complete the anxiety and depression screening measures (GAD-7 and PHQ-9 [minus item 9, which asks about suicidality]) and to note what mental health treatment they had received in the past 2 weeks.

In addition, GPs will receive a notification to their medical inbox if their patient:
• shows a change in symptom severity (deterioration or improvement) between fortnightly assessments,
• remains in the mild symptom range for four weeks
• remains in the moderate symptom range for four weeks,
• remains in the severe symptom range for four weeks,
• or does not complete their fortnightly assessments.

IMPLEMENTATION MODEL: ‘ITFITS TOOLKIT’
The ItFits Toolkit is a web-based Implementation tool that supports Implementers in developing, applying, and monitoring tailored Implementation strategies to integrate and embed iCBT services into routine mental health care. The ItFits Toolkit draws on research based around Normative Process Theory and the broader field of Implementation science. The ItFits Toolkit takes users through a series of up to four interactive online modules.

For this trial, implementation will focus on the first three of these modules, which focus on:
• Module 1: Setting implementation goals and identifying implementation barriers
• Module 2: Identifying strategies to overcome implementation barriers
• Module 3: Create a plan for carrying out these strategies

Implementation via the ItFits Toolkit will involve an Implementation Lead, who is responsible for leading the implementation of Youth StepCare within the practices using the techniques outlined in the ItFits Toolkit. In addition, the Implementation Lead will be supported by a Core Team of four implementation and mental health experts based at the Black Dog Institute, who assist the Implementation Lead in identifying implementation barriers and generating solutions.

Within each module, the ItFits Toolkit provides a systematically guided but flexible step-by-step process for the Implementation Lead to follow. For each module, the Implementation Lead and Core Team, works through three steps: (1) devise an initial plan, (2) have the plan reviewed by relevant stakeholders (GPs and practice staff) and then discuss with them their needs and priorities, and (3) finalise the plan based on the feedback from stakeholders. An important element of the ItFits Toolkit is engagement and consultation between the implementation team and stakeholders to ensure the best outcome.

Both groups receive the Youth StepCare intervention. In one of the groups, implementation of Youth StepCare will occur via an implementation-as-usual approach. In the other group, implementation of Youth StepCare will occur via a process informed by the ItFits toolkit. The ItFits toolkit is used by the Implementation Lead only and not the practice staff, GPs or patients. The Implementation Lead will begin using the ItFits toolkit to inform their implementation of Youth StepCare. Accordingly, use of the ItFits toolkit and implementation of the Youth StepCare screening tool will occur in parallel.

Implementation Leads will use the ItFits toolkit to inform their implementation for the entire duration of the trial. Accordingly, practices in the enhanced implementation arm will be exposed to implementation principles derived from the ItFits toolkit for the full 6 months that they have access to Youth StepCare.

Three modules from the ItFits toolkit will be used by the Implementation Lead in the Enhanced Intervention arm to inform their approach to Youth StepCare implementation. They will use principles from ItFits toolkit Module 1 during their first training session with a practice, and after 2-3 months of using Youth StepCare, will conduct a second visit to the practice to apply principles from ItFits toolkits Modules 2 and 3. It is anticipated that each visit to the practice will take 1-2 hours.

Adherence to the ItFits toolkit by the Implementation Lead will be monitored via recorded meetings between the Implementation Lead and Core Team. Independent raters will view the recordings to determine whether ItFits module content was or was not discussed, and whether discussion of module content proceeded in the manner described in the ItFits toolkit.
Intervention code [1] 319679 0
Early detection / Screening
Comparator / control treatment
Implementation-as-usual
Practices in the Implementation-As-Usual condition will be trained in accordance with the implementation procedures that have been found to be most effective in implementing the adult StepCare service. Rather than drawing on any theoretical model of implementation, this condition draws on the experiential knowledge of experienced implementers, and will serve as an active control comparison condition. The implementation activities include training sessions in stepped-care models, use of Youth StepCare, and in how to use recruitment scripts to invite participants to take part in screening, as well as how to respond to participants who may have questions or become distressed during screening. Following an initial training session, telephone and in-person support will be provided as needed.

All patients, practice staff and GPs in the Implementation-As-Usual condition will have full access to Youth StepCare and the programs integrated into the tool (e.g. Smooth Sailing). The only difference between practices in the Enhanced Implementation group and practices in the Implementation-As-Usual group will be the techniques that the Implementation Leads draw upon to help practices implement Youth StepCare into their practice workflow. For example, whereas training sessions with practices in the Enhanced Implementation condition will occur via a set structure consisting of two practice visits with consistent information covered in each visit (i.e., techniques specified in Modules 1 to 3 of the ItFits toolkit), training sessions with practices in the Implementation-As-Usual condition will occur in an unstructured manner and according to the individual needs of the practice.

The Implementation Leads (who are part of the research team) will be responsible for delivering all implementation training sessions to practices. Practice staff (e.g., reception staff and practice nurses) and GPs will be responsible for using Youth StepCare to screen and manage adolescent patients for the duration of the trial.
Control group
Active

Outcomes
Primary outcome [1] 326447 0
Primary outcome 1: Effectiveness of the Youth StepCare tool in identifying youth patients with undiagnosed/untreated depression and/or anxiety. This will be measured by the proportion of individuals who screen as experiencing symptoms of depression or anxiety and who answer “no” to the following questions: “Have you ever attended a doctor’s appointment for mental health reasons?” and “Are you attending this appointment for mental health reasons?”.
Timepoint [1] 326447 0
Baseline
Primary outcome [2] 326448 0
Primary outcome 2: Effectiveness of the ItFits Toolkit in increasing the use of digital mental health tools (i.e., Youth StepCare and digital mental health program recommended by Youth StepCare) in general practices.
This will be measured in two ways:
• The number of youth patients screened using Youth StepCare
• The proportion of patients with mild-to-moderate symptoms who are referred to the digital mental health program Smooth Sailing by their GP
Timepoint [2] 326448 0
Baseline
Secondary outcome [1] 391524 0
Secondary outcome 1: Change in GPs/practice staff Knowledge, Attitude, and Practice (KAP) of implementing digital mental health tools into the General Practice workflow. Measured using a purpose-built KAP survey adapted from Topooco et al. (2017), Parvin et al. (2016), and Moerman et al. (2014).
Timepoint [1] 391524 0
Baseline, 3 months, 6 months
Secondary outcome [2] 391525 0
Secondary outcome 2: Change in GPs/practice staff perceptions of the implementation process of embedding complex interventions into the healthcare system that change work practices. Measured using the Normalisation Measure Development questionnaire (NOMAD; Finch et al. 2018).
Timepoint [2] 391525 0
Baseline, 3 months, 6 months
Secondary outcome [3] 391526 0
Secondary outcome 3: Change in GPs/practice staff readiness for change to adopt a new digital intervention into their workflow. Measured using the Organizational Readiness for Implementing Change (ORIC; Shea et al. 2014).
Timepoint [3] 391526 0
Baseline, 3 months, 6 months
Secondary outcome [4] 391527 0
Secondary outcome 4: Adolescent patient's depressive symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ9; Kroenke et al 2001). From week 2 onwards, the 8-item Patient Health Questionnaire will be used (PHQ9; Kroenke et al 2009).
Timepoint [4] 391527 0
Baseline and weeks 2, 4, 6, 8, 10 and 12
Secondary outcome [5] 391528 0
Secondary outcome 5: Adolescent patient's anxiety symptoms will be measured using the 7-item Generalized Anxiety Disorder Scale (GAD7; Spitzer et al, 2006).
Timepoint [5] 391528 0
Baseline and weeks 2, 4, 6, 8, 10 and 12
Secondary outcome [6] 392590 0
Proportion of patients adhering to GP-prescribed treatments. Adherence to prescribed treatments will be assessed by comparing GP-reports of the treatment that was prescribed to a patient (assessed using the checkbox embedded within the Youth StepCare tool) with the treatments that the patient reported using during the follow-up period (assessed in the patient every 2 weeks using a checkbox)
Timepoint [6] 392590 0
Treatments prescribed by the GP will be captured at baseline and this will be compared to the treatments the patient reported using over the follow-up period (assessed fortnightly until week 12).

Eligibility
Key inclusion criteria
General Practitioner eligibility criteria
• Identified as treating young people in-person on a weekly basis, for any health condition;
• Are using Best Practice or Medical Director Software;
• Have WIFI available in the practice;
• Have an overall internet speed of at least 10mbps;
• Have HealthLink or MedicalObjects secure messaging service installed or willingness to have it installed;
• Have the willingness to provide feedback on what type of care they recommend to youth patients with mental health problems.

Practice Staff eligibility criteria:
Practice staff (i.e. reception staff, practice nurses, practice managers) that have provided their consent will be invited to participate in the study.

Adolescent Patient eligibility criteria:
Young people presenting for an appointment to a participating GP at a participating practice will be invited to participate in the study if they are:
• Aged 15 to 17;
• Able to provide informed consent
• Ability to understand English (read and spoken);
• Have a valid email address and access to a mobile device
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practices:
• General Practices currently using the adult StepCare digital screening service will be excluded.

Adolescent Patients:
• Previously screened within the past 6 months.
• A GP determines a patient is not well enough to participate (e.g., vomiting, weak, cognitively impaired)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation process will be prepared and conducted by an off-site statistician who is not involved in the day-to-day conduct of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Cluster randomisation at the General Practice level will be used to avoid contamination effects from other participating GPs and General Practice Staff. General Practices will be randomised with a 1:1 allocation stratified by practice size. The allocation will not be disclosed to ensure concealment.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SAMPLE SIZE

General Practice Staff:
The sample size for the current study is 19 practice staff per implementation condition (38 total practice staff). This sample size is sufficient to compare the effectiveness of the two implementation models, and is based on estimates reported in the official trial protocol paper for the broader study for which the Enhanced Implementation Model (i.e., the ‘It Fits Toolkit’) was developed (Bührmann et al., 2020). It is estimated that 3-5 GP practices per implementation condition (6-10 GP practices in total) will be needed to reach the target sample of practice staff.

Adolescent Patients:
The sample size for patients is n=393. This allows us to find a pre/post treatment effect size of 0.2 with 80% power and an alpha level of 0.05 (Cohen, 1992). This number will allow us to determine whether symptoms of depression and anxiety in patients who were screened improve over the follow-up period.

ANALYSES

All data will be analysed using SPSS and STATA using descriptive statistics to describe the demographics and baseline symptom characteristics of the patients.

Primary outcome 1:
The proportion of undiagnosed/untreated adolescent patients with depression and/or anxiety identified through screening will be calculated as a percentage of the total number of adolescent patients who were invited to take part in screening.

Primary outcome 2:
Effectiveness of the two implementation conditions in promoting uptake of Youth StepCare (i.e., number of patient screened) and Smooth Sailing (number of patients referred to Smooth Sailing) will be analysed using two separate Generalised Linear Mixed Models with Implementation Condition as the independent variable.

Secondary outcomes 1-3:
Changes in KAP, NOMAD and ORIC scores across the three measurement time points (baseline, 3 months, 6 months) between the two implementation conditions will be assessed using three separate linear mixed effect models. Predictors in each model will be a main effect of Time, a main effect of Implementation Condition, and a Time x Implementation interaction.

Secondary outcomes 4 and 5:
Changes in depression (PHQ-9 scores) and anxiety (GAD-7 scores) in adolescent patients from baseline to weeks 2, 4, 6, 8, 10 and 12 will be evaluated using two separate linear mixed effect models. Predictors in each model will be a main effect of Time. The proportion of patients who can be considered "remitters" (i.e., in the nil/minimal range on their last follow-up assessment) and "responders" (i.e., those who dropped down at least one severity level on the PHQ-9 or GAD-7 at their last follow-up assessment) will also be calculated.

Secondary outcome 6:
The proportion of patients adhering to GP-prescribed treatments will be calculated as the proportion of patients who reported using the treatment their GP had prescribed, at some point over the 12-week follow-up period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/04/2021
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
393
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 307782 0
Charities/Societies/Foundations
Name [1] 307782 0
Paul Ramsay Foundation
Country [1] 307782 0
Australia
Funding source category [2] 307783 0
Government body
Name [2] 307783 0
National Health and Medical Research Council
Country [2] 307783 0
Australia
Funding source category [3] 307784 0
Government body
Name [3] 307784 0
NSW Department of Health Prevention Hub
Country [3] 307784 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW, Sydney, NSW, Australia, 2052
Country
Australia
Secondary sponsor category [1] 308491 0
None
Name [1] 308491 0
Address [1] 308491 0
Country [1] 308491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307801 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 307801 0
Ethics committee country [1] 307801 0
Australia
Date submitted for ethics approval [1] 307801 0
20/11/2020
Approval date [1] 307801 0
18/12/2020
Ethics approval number [1] 307801 0
HC200257

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

Contacts
Principal investigator
Name 108546 0
Dr Alexis Whitton
Address 108546 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 108546 0
Australia
Phone 108546 0
+61 2 9382 8507
Fax 108546 0
Email 108546 0
a.whitton@blackdog.org.au
Contact person for public queries
Name 108547 0
Alexis Whitton
Address 108547 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 108547 0
Australia
Phone 108547 0
+61 2 9382 8507
Fax 108547 0
Email 108547 0
a.whitton@blackdog.org.au
Contact person for scientific queries
Name 108548 0
Alexis Whitton
Address 108548 0
Black Dog Institute, Hospital Road, Randwick, NSW, 2031
Country 108548 0
Australia
Phone 108548 0
+61 2 9382 8507
Fax 108548 0
Email 108548 0
a.whitton@blackdog.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This will not be available as per the conditions of our ethical approval.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10459Ethical approval    381372-(Uploaded-06-02-2021-12-31-59)-Study-related document.pdf
10460Informed consent form    381372-(Uploaded-06-02-2021-12-33-25)-Study-related document.pdf



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.