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Trial registered on ANZCTR


Registration number
ACTRN12623000208606
Ethics application status
Approved
Date submitted
20/12/2022
Date registered
27/02/2023
Date last updated
5/10/2024
Date data sharing statement initially provided
27/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation evaluation of a blended digital mental health intervention for adults with depression or anxiety
Scientific title
Implementation evaluation of a blended digital mental health intervention for adults receiving psychological therapy for depression or anxiety
Secondary ID [1] 308647 0
Nil known
Universal Trial Number (UTN)
U1111-1285-8587
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 328558 0
Anxiety 328559 0
Condition category
Condition code
Mental Health 325574 325574 0 0
Depression
Mental Health 325575 325575 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BLENDED MODEL OF CARE
The current study will evaluate a new model of blended care for depression and anxiety. Blended models of care combine traditional psychotherapy (either face-to-face or telehealth-delivered) with digital interventions. The blended model of care used in the current study will include two main digital components, which will be integrated into routine psychological therapy: (1) a client-facing smartphone-based mobile application (app), and (2) a practitioner-facing Health Professional Portal.

SMARTPHONE APP
The mobile application provides therapeutic skills and management strategies for adults experiencing symptoms of depression and/or anxiety. The app content draws on a variety of therapeutic approaches (including Cognitive Behavioural Therapy, Mindfulness and Emotion Regulation techniques).

The mobile app is a non-sequential intervention consisting of eight therapeutic ‘programs’. The therapeutic programs are presented in a manner that is designed to align with common therapy goals, and are:
1. Feel happier
2. Cope with anxiety
3. Feel more relaxed
4. Sleep better
5. Think positively
6. Build confidence
7. Increase focus
8. Manage emotions

Each of the therapy programs include 10 brief psychotherapeutic activities that are designed to support the following evidence-based treatment components: psychoeducation, cognitive restructuring, emotion awareness and acceptance, goal setting, problem solving, behavioural activation, exposure, relaxation, mindfulness, and values labeling. The activities vary in length, taking between 5 to 10 minutes each to complete, meaning that each program of 10 activities takes, on average, between 60 and 90 minutes to complete.

At the start of treatment, users can select therapy programs (up to 3 initially) that they would like to begin working through. This selection can occur with the input of their treating psychologist. Based on their program selection, each user is then recommended five activities to get them started.

Client participants will be asked to spend 10 minutes a day completing activities within the app. All activities are delivered with short informative text, ability to select or provide free text responses and often with engaging illustrations, photos or audio exercises. App analytics will be collected (e.g., number and type of activities completed) and participants asked about their engagement with the intervention to monitor adherence.

All psychologists participating in the study will hold provisional or full registration as a psychologist with AHPRA and will have received online training in how to use the mobile app with their clients. Psychologists will complete the training at least one week before commencement of the intervention. A member of the research team will provide a single one hour session delivered over Zoom. The blended model of care will be delivered in the context of individual therapy, and all clients participating in the study will have access to use the mobile app with their psychologist for a 3-month implementation period.

HEALTH PROFESSIONAL PORTAL
In addition to having access to the mobile app to use with their clients, psychologists will have access to a Health Professional Portal that is connected to the mobile app. While using the app, clients will complete questionnaires to assess aspects of their mental health (e.g., severity of symptoms of depression and anxiety). Client summary scores will then be sent to the Health Professional Portal, where psychologists will be able to view them to track their clients’ progress throughout treatment.

Psychologists will have access to the Health Professional Portal during the entire study period and will only be able to view their clients’ scores and will not be able to see the scores of the clients of other participating psychologists.
Intervention code [1] 325111 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333418 0
Acceptability (clients): Client’s perceived acceptability with the blended care program will be assessed using the 4-item Client Satisfaction Questionnaire (CSQ-4; Greenfield, 1983, adapted from the original CSQ-8 by Larsen, Attkisson, Hargreaves, & Nguyen, 1979). The CSQ-4 is a Likert scale with 4 items and assesses client satisfaction with services delivered.
Timepoint [1] 333418 0
3 months post-commencement of intervention
Primary outcome [2] 333419 0
Feasibility (psychologists): Psychologists’ perceived feasibility of delivering the blended model of care as part of routine therapy with clients will be assessed via changes in normalisation, measured using the NoMAD questionnaire. Normalisation refers to the actions people do to embed and integrate an innovation in routine practice. The Normalisation Assessment Development (NoMAD) is a 23-item self-report questionnaire that taps four core concepts (Coherence, Cognitive Participation, Collective Action, Reflexive Monitoring) of a key theoretical model of normalisation (Normalisation Process Theory).
Timepoint [2] 333419 0
Change from baseline to 6 months post-commencement of intervention
Primary outcome [3] 333420 0
Client changes in symptoms of psychological distress measured using the 21-item Depression, Anxiety and Stress Scales (Lovibond & Lovibond, 1995).
Timepoint [3] 333420 0
Change from baseline to 3 months post-commencement of intervention
Secondary outcome [1] 416999 0
Client retention (number of clients dropping out of treatment prematurely during the implementation period, as reported by psychologists)
Timepoint [1] 416999 0
6 months post-commencement of intervention
Secondary outcome [2] 417018 0
Client adherence (number of activities completed within the app) assessed via app analytics
Timepoint [2] 417018 0
3 months post-commencement of intervention
Secondary outcome [3] 417019 0
Treatment satisfaction questionnaire (TSQ; Kladnitski et al. 2018) (administered to clients)
Timepoint [3] 417019 0
3 months post-commencement of intervention
Secondary outcome [4] 417020 0
Strength of therapeutic relationship assessed with the Working Alliance Inventory (WAI-SR; Hatcher & Gillaspy, 2006) (administered to clients)
Timepoint [4] 417020 0
Baseline, 3 months, 6 months post-commencement of intervention
Secondary outcome [5] 417021 0
Attitudes towards eTherapy and e-Therapy use (administered to clients)
Timepoint [5] 417021 0
Baseline, 3 months, 6 months post-commencement of intervention
Secondary outcome [6] 417022 0
Adapted Mobile Application Rating Scale (MARS; Stoyanov et al., 2015) (administered to clients)
Timepoint [6] 417022 0
3 months post commencement of intervention
Secondary outcome [7] 417023 0
Study-specific Client feedback survey (administered to clients)
Timepoint [7] 417023 0
3 months post-commencement of intervention
Secondary outcome [8] 417024 0
Recovering Quality of Life scale-10 item (ReQoL; Keetharuth et al., 2018) (administered to clients)
Timepoint [8] 417024 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [9] 417025 0
Work and Social Adjustment Scale (WSAS; Mundt et al. 2002) (administered to clients)
Timepoint [9] 417025 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [10] 417026 0
Patient Health Questionnaire (PHQ-9; Kroenke et al. 2001) (administered to clients)
Timepoint [10] 417026 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [11] 417027 0
Generalised Anxiety Disorder scale (GAD-7; Spitzer et al, 2006) (administered to clients)
Timepoint [11] 417027 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [12] 417028 0
Attitudes towards eTherapy and e-Therapy use (administered to psychologists)
Timepoint [12] 417028 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [13] 417029 0
Knowledge, attitudes and practice questionnaire (administered to psychologists)
Timepoint [13] 417029 0
Baseline, 3 months, 6 months post commencement of intervention
Secondary outcome [14] 417030 0
System Usability Scale (administered to psychologists)
Timepoint [14] 417030 0
3 months post-commencement of intervention
Secondary outcome [15] 418819 0
Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al., 1995) (administered to clients)
Timepoint [15] 418819 0
Baseline, 3 months, 6 months post commencement of intervention

Eligibility
Key inclusion criteria
Two types of participants will be recruited for this study: psychologists and their clients. The key inclusion criteria for each of these types of participants is as follows:

Psychologists
1. Provisional psychologist or psychologist registered with AHPRA
2. Practicing in Australia
3. English speaking
4. Currently providing mental health care to adults with anxiety or depression

Clients
1. Self-reported symptoms of anxiety or depression
2. 18 years of age or older
3. Currently residing in Australia
4. English speaking
5. Has a mobile phone number and email address
6. Owns a smartphone device using a supported operating system (Apple: iOS 13 released 1999 or newer; Android: 7.0 released 2016 or newer)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for those who are not eligible to participate in the study are as follows:

Psychologists
1. Those who are not currently practicing or who do not work with adults with anxiety or depression
2. Other mental health professionals (e.g., social workers) who work with adults with anxiety and depression (future studies may extend to other health professional groups beyond psychologists)

Clients
1. Clients who are under the age of 18 (as this program is designed for adults)
2. Clients who are actively suicidal as determined by their psychologist (as these clients may benefit from more intensive psychological therapy)
3. Clients experiencing a psychotic disorder (as symptomatology may influence their ability to engage with the intervention and respond to evaluation measures)

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
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
43 psychologists participated in the trial. The psychologists invited 132 of their clients to participate in the trial, and of those, 66 were recruited. Two clients were excluded from the dataset therefore the final client sample was 64.

Psychologists were responsible for inviting any new clients with anxiety and/or depression that they believe meet the inclusion criteria (and did not meet the exclusion criteria) to participate in the study.

Mixed effects models for repeated measures ANOVA (MMRM) will be employed to analyse data over multiple assessment points within groups. MMRM is recommended for repeated measures data with psychological variables over other traditional techniques (Meteyard & Davies, 2020). For changes in client symptoms of psychological distress over time, we anticipate small-to-medium effect sizes (Lecomte et al., 2020). Conservatively allowing for a correlation of 0.50 between occasions of measurement and up to 20 attrition, the client sample size of n = 100 will maintain 80% power to detect a change corresponding to near small effect size (d=0.32).

In addition to quantitative methods, qualitative data was collected from a subset of clients (N=11) and all psychologists through one-on-one interviews. This sample size is estimated based on past research involving people with anxiety and depression (e.g., Kadam et al., 2001) and health professionals (Mol et al., 2019), with sufficient data for theme saturation and to generate the necessary data and distribution of views and perspectives.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/02/2023
Actual
19/06/2023
Date of last participant enrolment
Anticipated
28/08/2023
Actual
29/02/2024
Date of last data collection
Anticipated
28/02/2024
Actual
19/09/2024
Sample size
Target
150
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 312881 0
Charities/Societies/Foundations
Name [1] 312881 0
HCF Research Foundation
Country [1] 312881 0
Australia
Primary sponsor type
University
Name
University of New South Wales, Sydney
Address
Research Ethics & Compliance Support
UNSW Sydney
Sydney NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 314557 0
None
Name [1] 314557 0
Address [1] 314557 0
Country [1] 314557 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312159 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 312159 0
Ethics committee country [1] 312159 0
Australia
Date submitted for ethics approval [1] 312159 0
03/08/2022
Approval date [1] 312159 0
16/09/2022
Ethics approval number [1] 312159 0
HC220527

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

Contacts
Principal investigator
Name 123682 0
Prof Jill Newby
Address 123682 0
Black Dog Institute, University of New South Wales, Sydney
Hospital Rd, Randwick NSW 2031 Australia
Country 123682 0
Australia
Phone 123682 0
+61 29065 9108
Fax 123682 0
Email 123682 0
j.newby@unsw.edu.au
Contact person for public queries
Name 123683 0
Kathleen O'Moore
Address 123683 0
Black Dog Institute, University of New South Wales, Sydney
Hospital Rd, Randwick NSW 2031 Australia
Country 123683 0
Australia
Phone 123683 0
+61 2 9065 9125
Fax 123683 0
Email 123683 0
k.omoore@blackdog.org.au
Contact person for scientific queries
Name 123684 0
Jill Newby
Address 123684 0
Black Dog Institute, University of New South Wales, Sydney
Hospital Rd, Randwick NSW 2031 Australia
Country 123684 0
Australia
Phone 123684 0
+61 29065 9108
Fax 123684 0
Email 123684 0
j.newby@unsw.edu.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
17901Informed consent form    385156-(Uploaded-20-12-2022-15-57-29)-Study-related document.docx
17902Ethical approval    385156-(Uploaded-19-12-2022-18-26-38)-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.