ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000422921

Ethics application status

Approved

Date submitted

18/02/2020

Date registered

30/03/2020

Date last updated

21/04/2022

Date data sharing statement initially provided

30/03/2020

Date results information initially provided

21/04/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

LIFE FLeX: An Adaptive Treatment Randomised Controlled Trial for Reducing Anxiety and Depression for Adults.

Scientific title

An Evaluation of Low Intensity Digital Mental Health Treatment Models for Reducing Anxiety and Depression in Adults: An Adaptive Treatment Randomised Controlled Trial

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

U1111-1239-7297

Trial acronym

Nil.

Linked study record

Nil known.

Health condition

Health condition(s) or problem(s) studied:

Anxiety

Depression

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A self-help, transdiagnostic digital mental health treatment program for reducing symptoms of anxiety and depression (called LIFE FLeX) delivered through the My Digital Health Platform will be evaluated in an adaptive randomised control design. Participants who consent and meet the study criteria will be given access to the LIFE FLeX digital health program immediately, however will be monitored for symptom improvement between two to three weeks post trial commencement. If a participant is not making progress (i.e., no change in anxiety and depression symptoms) they will be offered to augment their program with a therapist and randomly assigned to one of two treatment conditions Arm One; meet weekly with a therapist online via video-chat technology for up to 10 minutes or Arm Two; meet weekly with a therapist online via video-chat for up to 50 minutes. Video-chat support duration will be dependent upon the stage of module completion at which the participant is allocated a therapist. The maximum duration of therapist support delivered by video-chat will be up to 7 weeks.

The LIFE FLeX program is designed to provide people with information and strategies to address their anxiety and depressive symptoms and contains six ‘core’ modules, plus an Introduction module delivered over 8 weeks (participants are provided two weeks to complete module 4). There will also be a short two page ‘Booster’ module three weeks following the post-intervention assessment. The booster module will release at that time and participants will be notified by email that it has been released.

The six core LIFE FLeX digital health program modules are:

1. Increasing Biological Flexibility: Looks at the biology of the stress response, understanding what biological flexibility is and what techniques to use to increase biological flexibility (e.g., increasing physical activity, breathing control).
2. Increasing Emotional Flexibility: Looks at what emotions are, increasing emotional awareness, and use of emotional regulation strategies.
3. Increasing Thinking Flexibility: Looks at the role of thoughts in depression and anxiety and how to increase thinking flexibility (e.g., identifying and challenging unhelpful thoughts).
4. Increasing Behavioural Flexibility: Looks at how what we do influences how we think and feel and how to increase behavioural flexibility through reducing avoidance through gradual exposure (for anxiety) and increasing activity through behavioural activation (for depression).
5. Increasing Wellness (positive affect) Flexibility: Looks at wellness and positive affect and how to increase wellness through various strategies (e.g., acts of kindness, openness to experience, social connectedness).
6. Increasing Life FLeX-ability: Recap’s the entire program, reflects over progress and discusses relapse prevention.

Each module of the LIFE FLeX program will take approximately 25 minutes to complete. In order to reinforce the module-based information, there are 20-30 minutes of offline activities each week, which include applying the concepts / techniques discussed such as self-monitoring symptoms, undertaking one of the increasing biological and wellness flexibility intervention strategies, monitoring emotions and thoughts and undertaking the gradual exposure or behavioural activation activity. Participants will also receive automated emails (e.g., to remind them to log on, when to complete ‘during’, post/follow-up intervention questionnaires) and will be asked several questions at the beginning and of each module to help gauge their progress. Modules include text, graphics, audio, video, editable forms, interactive games (e.g., brain training) and downloads. Modules can be accessible via web, mobile or tablet devices.

Provisionally registered psychologists with Australian Health Practitioner Regulation Agency (AHPRA) who are in their 5th and 6th year of training within psychology will deliver the intervention in the two therapist assisted conditions.

The therapists of the study delivering the intervention will receive a training package on diagnostic assessment (the MINI), semi-structured interviewing techniques, digital mental health interventions; specifically ethical and legal aspects of service provision for the use of video-chat technology to deliver treatment. The therapists of the study will be required to complete a mixture of online modules and workshops to ensure knowledge and competency with all therapists required to pass competency checks prior to commencing interaction with participants.

Arm 1: Minimal support condition (supportive role)- Therapist support will be delivered weekly via video-chat technology, for up 10 minutes. The role of the therapist in the ‘minimal’ support treatment condition is to support the participant’s engagement with the LIFE FLeX program by specifically checking on participant progress with modules, participant understanding of program material, provide clarification where required and ensure that participants are clear on their between session module tasks assigned for completion. It will be important to ensure that fidelity of therapists’ role is maintained, that is, the therapists of the study remain in their ‘supporter’ role and do not to drift into therapy mode.
Arm 2: High support condition (therapist role) - Treatment will be delivered weekly via video-chat technology, for up to 50 minutes. The role of the therapist in the ‘high’ support treatment condition is to deliver the content of the transdiagnostic program LIFE FLeX to participants in the role of therapist and then to redirect participants to the online program LIFE FLeX for revision and consolidation of material in between scheduled sessions.
In order to ensure treatment fidelity and standardised treatment, the therapists will be provided with treatment manuals with random spot checks of their recorded video-chat sessions reviewed by two independent raters to determine adherence to study protocol. The provisional psychologists will receive regular opportunities for individual and group supervision from a registered clinical psychologist and AHPRA registered supervisor where any remedial strategies to improve fidelity will be implemented. Remedial strategies will include the provision of constructive feedback, a review of the components of treatment in sequence, further practice of skills where drift may have occurred, additional training (if necessary), review of initial fidelity training materials, and extra coaching/ supervision.

Several semi-structured interview schedules designed to assess attrition, participant and therapist experiences of receiving and delivering treatment via video-chat technology, along with assisting implementation efforts post -trial have also been created for the study. The interview schedules are estimated to take approximately 10-15 minutes and will be offered to participants via telephone, instant messaging or video-chat.

Intervention code [1]

Treatment: Other

Comparator / control treatment

If participants fail to improve within the ‘no human support’ program within the first two to three weeks (i.e., no change in anxiety and depression symptoms), then they will be randomised to augment their program with either ‘minimal’ human support (i.e., up to 10 minute of a support session per week) or ‘high’ human support (i.e., up to 50 minutes of a therapy session per week), delivered by video-chat technology).

Control group

Active

Outcomes

Primary outcome [1]

Primary Outcome- Anxiety
Change in anxiety scores as measured by the Generalised Anxiety Disorder Questionnaire (GAD-7).

Timepoint [1]

Baseline, 3, 6, 9 and 21 weeks after intervention commencement.

Primary outcome [2]

Primary Outcome- Depression
Change in depression scores as measured by the Patient Health Questionnaire (PHQ-9).

Timepoint [2]

Baseline, 3, 6, 9 and 21 weeks after intervention commencement.

Secondary outcome [1]

Secondary Outcome 1 – Motivation
Change in client motivation scores as measured by the Client Motivation for Therapy Scale (CMOTS).

Timepoint [1]

Baseline and 9 weeks after intervention commencement.

Secondary outcome [2]

Secondary Outcome 2- Self-Efficacy
Change in self-efficacy scores as measured by the Modified- Bipolar Self-Efficacy Scale (M-BPSES).

Timepoint [2]

Baseline and 9 weeks after intervention commencement.

Secondary outcome [3]

Secondary Outcome 3- Quality of Life
Change in quality of life scores as measured by the Assessment of Quality of Life (AQol-4D).

Timepoint [3]

Baseline, 9 and 21 weeks after intervention commencement.

Secondary outcome [4]

Secondary Outcome 4- Therapeutic Alliance
Change in therapeutic alliance scores as measured by the Modified Working Alliance Inventory- Short (Three versions; Technological Alliance, Participant Version and Therapist Version).

Timepoint [4]

Week 3, 6 and 9 weeks after intervention commencement.

Secondary outcome [5]

Secondary Outcome 5- System Usability Scale
Self developed questions to assess participants’ ease of program usability

Timepoint [5]

3 weeks after intervention commencement

Secondary outcome [6]

Secondary Outcome 6- Record of Health Services Utilisation
Participants will be required to maintain a record of their use of services during the trial (self-developed questions)

Timepoint [6]

To be maintained by participants’ throughout trial

Secondary outcome [7]

Secondary Outcome 7- Participant Satisfaction Questionnaire
Intervention satisfaction assessed by self-developed satisfaction questionnaire

Timepoint [7]

9 weeks after program commencement

Secondary outcome [8]

Secondary Outcome 8- Participant Preferences Questionnaire
Participants’ preferences for treatment assessed by self-developed preferences questionnaire

Timepoint [8]

Pre-program commencement

Eligibility

Key inclusion criteria

Inclusion criteria – participants
a) Australian residents
b) 18 years or older
c) Have access to the internet
d) Able to read in English
e) Be able to register online, using an email address
f) Provide their informed consent
g) Medication stability
h) Primary diagnosis of anxiety or depression, or mixed anxiety and depression or sub-clinical symptoms of anxiety/ and or depression confirmed by the MINI diagnostic assessment

Inclusion criteria- therapists
a) At a minimum, the therapists of the study must have provisional registration as a psychologist with Australian Health Practitioner Regulation Agency (AHPRA).

Inclusion criteria- other
Local providers who offer mental health treatment services in the community (e.g., private practice, government funded or mental community health, and other NGOs) will be eligible to participate.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

a) Participants who have active psychosis
b) Suicidal ideation/ behaviours
c) Problematic alcohol or drug use
d) Concurrent psychotherapy
e) No internet access
f) Participants who do not provide a valid email address
g) Participants who do not consent to the conditions of the study

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)

sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table from a statistic book

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Only aggregate data will be used for main analysis. Assuming a conservative medium
effect (i.e. GPower f(v) test = 0.40), significance set at 5% (p = .05), power at 80%, 32 participants per condition is required to demonstrate statistical significance on the primary outcome measure. However, allowing for a 50% attrition rate, we will be required to recruit 64 participants per condition (total 192 participants).

Pre-, during, post- and follow-up variables will be subjected to mixed methods and repeated measures analyses to determine significant changes over group and time. Correlational, multiple regression, mediation and moderation analyses will be used to determine any potential predictors and discriminators of attrition and adherence. Open ended data obtained from intervention satisfaction questionnaires and interview questions will be analysed using protocols of content analysis to identify common themes.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

29/04/2020

Actual

28/01/2021

Date of last participant enrolment

Anticipated

31/03/2021

Actual

30/09/2021

Date of last data collection

Anticipated

26/08/2021

Actual

30/03/2022

Sample size

Target

192

Accrual to date

Final

240

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Federation University

Address [1]

PO Box 663
Ballarat Vic 3353
Australia

Country [1]

Australia

Primary sponsor type

University

Name

Federation University

Address

PO Box 663
Ballarat Vic 3353
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Research Ethics Committee (HREC), Federation University Australia

Ethics committee address [1]

Office 218
Building F, Mt Helen Campus
Federation University
PO Box 663
Ballarat, Vic 3353

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/07/2019

Approval date [1]

08/08/2019

Ethics approval number [1]

A19-095

Summary

Brief summary

A transdiagnostic, cognitive behavioural and biopsychosocially-based digital health program for decreasing symptoms of anxiety and depression (called LIFE FLeX) will be evaluated in various treatment intensities. People who consent will be given access to the LIFE FLeX program immediately however if their symptoms of anxiety and depression do not improve within the first two to three weeks will be offered to have their treatment stepped-up and randomly allocated to one of two groups 1) LIFE FLeX program + allocation of a therapist for up to 10 minutes of weekly support conducted via video-chat technology and; 2) LIFE FLeX program + allocation of a therapist for up to 50 minutes of weekly support conducted via video-chat technology.

LIFE FLeX is designed to assist people with their anxiety and depressive symptoms and contains six 'core' modules, plus an introduction module delivered over 8 weeks. There will also be a short 'Booster' Module released three weeks after the final module is completed.

Each module will take approximately 25 minutes to complete. In addition, in order to reinforce the module-based information, there are 20-30 minutes of offline activities each week. Participants will also receive automated emails (e.g., to remind them to log on, when to complete post/follow-up questionnaires) and will be asked to self-monitor their mood and daily lifestyle events (e.g., sleep) and asked several questions at the beginning of each module, to monitor their progress.

Participants will complete a pre-intervention assessment (Week 0), during intervention (Weeks 3, 6) assessments, post-intervention assessment (Week 9) and a 3-month follow-up assessment (Week 21). In addition, participants who withdraw from the study, or those who progress to a therapist condition will be invited to complete a semi-structured interview to explore their reasons around disengagement and experiences of the therapeutic alliance and effects of video-chat as a delivery method on the therapeutic alliance. Interviews will be conducted via telephone, instant messaging or video-chat.

It is expected that people who have their treatment program (LIFE FLeX) augmented with a therapist will show greater reductions in anxiety and/or depressive symptoms at post-intervention assessment and follow-up assessment time points, as well as increases in positive affect and emotional regulation, in comparison to people in the maintenance of the 'no support' LIFE FLeX program.

Trial website

https://feduniclinic.mydigitalhealth.org.au

Trial related presentations / publications

Public notes

Participants will complete a pre-program survey (Week 0), a during program survey (Week 3 and 6), a post-program survey (Week 9) and a three-month follow-up survey (Week 21). All participants who opt to withdraw from the study or those who progress to stage two will also be invited to participate in a brief interview to better understand user engagement and experiences with therapy delivered via video-chat technology. The provisional psychologists, psychology clinic staff at Federation University and local service providers will also be invited to participate in a brief interview to better explore real-world implementation issues.

Contacts

Principal investigator

Name

Prof Britt Klein

Address

DVC-RI Portfolio and BeRI
Federation University
107 Lydiard Street South
Ballarat Central VIC 3353
PO Box 663
Ballarat, Vic 3353

Country

Australia

Phone

+61 3 5327 6716

Fax

[email protected]

Contact person for public queries

Name

Ms Brooke Andrews

Address

Biopsychosocial and eHealth Research & Innovation (BeRI) Hub
Federation University
107 Lydiard Street South
Ballarat Central VIC 3353
PO Box 663
Ballarat VIC 3353

Country

Australia

Phone

+61 3 5327 9623

Fax

[email protected]

Contact person for scientific queries

Name

Ms Brooke Andrews

Address

Biopsychosocial and eHealth Research & Innovation (BeRI) Hub
Federation University
107 Lydiard Street South
Ballarat Central VIC 3353
PO Box 663
Ballarat VIC 3353

Country

Australia

Phone

+61 3 5327 9623

Fax

[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?

Individual participant data of published results only, after de-identification.

When will data be available (start and end dates)?

No start or end date as yet determined.

Available to whom?

Case-by-case basis at the discretion of the Principal Investigator

Available for what types of analyses?

Case-by-case basis at the discretion of the Principal Investigator

How or where can data be obtained?

Access subject to approval by Principal Investigator, followed by submission to the Ethical Review Committee to access the de-identified data and approval granted. The Principal Investigator, Professor Britt Klein can be contacted via the below details:

Professor Britt Klein
DVC-RI Portfolio and BeRI
Federation University
107 Lydiard Street South
Ballarat Central VIC 3353
PO Box 663
Ballarat

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Plain language summary	No		Data is yet to be analysed

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Efficacy of a Digital Mental Health Biopsychosocial Transdiagnostic Intervention With or Without Therapist Assistance for Adults With Anxiety and Depression: Adaptive Randomized Controlled Trial.	2023	https://dx.doi.org/10.2196/45135

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically