Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000826549
Ethics application status
Approved
Date submitted
19/06/2024
Date registered
4/07/2024
Date last updated
4/07/2024
Date data sharing statement initially provided
4/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of an online program for youth anxiety.
Scientific title
Randomised controlled trial testing the effect of imagery-based motivation enhancement on youth engagement with an online anxiety program.
Secondary ID [1] 305818 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326548 0
Condition category
Condition code
Mental Health 321825 321825 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study aims to test the effectiveness of an online session delivering imagery-based motivation enhancement to improve youth engagement with an internet-based Cognitive Behavioural Therapy (CBT) intervention for anxiety.
The motivation enhancement session is based on Functional Imagery Training (FIT), which is a treatment approach developed to enhance motivation for positive behaviour change. FIT is based on Elaborated Intrusion Theory of desire which posits that desire is driven by a process of cognitive elaboration of which mental imagery is a key component. The more vivid an image about a target is, the stronger the desire will be. FIT combines training in mental imagery with the client-centred counselling style of Motivational Interviewing (MI) to engage people in conversations about the positive benefits of change, building self-efficacy and goal-directed planning. FIT involves supplementing these verbal discussions with guided mental imagery, strengthening desire for the imagined goal.
This imagery-based session will deliver a brief, self-guided form of FIT which aims to enhance motivation to engage with the program and to complete homework tasks. This online session will provide imagery psychoeducation, explore benefits of change and of completing the program, build self-efficacy for change, goal setting and planning. Throughout the session, participants are invited to create mental images relating to the different areas of discussion. The imagery session is expected to take participants approximately 30 minutes to complete.
This imagery session will precede the 7-session online anxiety program. This is delivered on the Momentum platform (www.momentumhub.org.au). The Momentum Anxiety program is an individual, interactive, self-guided, internet-based CBT program for young people experiencing elevated levels of anxiety. The program is comprised of 7 sessions focusing on psychoeducation, the maintaining role of avoidance in anxiety, and a variety of graded-exposure and cognitive restructuring strategies as well as relapse prevention.
Participants can input responses directly into the online platform but will be informed and reminded throughout the program that the content is not monitored or reviewed. At the end of each session participants are assigned homework tasks to complete before their next login. It is expected that homework tasks will take participants an average of 30 minutes to complete each week, though this will vary across participants depending how much time they are able/choose to spend on the practise activities. Homework completion is recorded as a binary yes/no response based on whether they attempted their homework activities.
Session completion times will also vary across participants, but on average it is expected that completing each session will take approximately 30-60 minutes. Participants are welcome to log in at times that are convenient to them and to complete the program at a pace that suits them, though it is suggested that they try to log in and complete at least one session per week. Participants can complete the online sessions alone or with support of a parent or caregiver, depending on their age. The platform records the date of completed sessions. A session is considered completed if every page has been clicked through until the final screen.
The content is based on other evidence-based CBT interventions and was developed by a group of experienced researchers and clinical psychologists with significant experience in developing innovative solutions for child and adolescent mental health concerns.
The intervention arm where participants receive the imagery-based motivation enhancement session followed by the standard 7-session Momentum Anxiety program is called the AnxietyPlus arm.
Intervention code [1] 322212 0
Treatment: Other
Intervention code [2] 322382 0
Behaviour
Comparator / control treatment
The control treatment consists of the Momentum Anxiety program alone (Anxiety), which is compared against the Momentum Anxiety program preceded by the imagery-based motivation enhancement session (AnxietyPlus).
Control group
Active

Outcomes
Primary outcome [1] 329826 0
Young people’s engagement with the online platform measured as the total number of Momentum Anxiety program sessions completed. This is recorded by the platform and all screens must be clicked through until the final screen of the session for a session to be recorded as completed.
Timepoint [1] 329826 0
3 months post baseline.
Primary outcome [2] 329827 0
Young people’s engagement with homework tasks measured as the total number of self-reported homework tasks completed between each session.
Timepoint [2] 329827 0
3 months post baseline.
Secondary outcome [1] 410396 0
Changes in anxiety symptom severity measured using the Spence Children's Scale for Anxiety
Timepoint [1] 410396 0
3 months and 6 months post Baseline
Secondary outcome [2] 410399 0
Cost effectiveness of the Anxiety treatment arm relative to costs of current standard treatments (i.e. face to face treatment) measured using the Child Health Utility Instrument 9 Dimensions and self-reported health service usage data. Costs of current standard treatment will be determined from existing literature and datasets, e.g., MBS data.
Timepoint [2] 410399 0
3 months and 6 months post Baseline
Secondary outcome [3] 410400 0
Cost effectiveness of the Anxiety treatment arm relative to the AnxietyPlus treatment arm measured using the Child Health Utility Instrument 9 Dimensions and self-reported health service usage data.
Timepoint [3] 410400 0
3 months and 6 months post Baseline

Eligibility
Key inclusion criteria
For inclusion participants must be aged from 7 to 17 years and be experiencing elevated levels of anxiety as measured on the Spence Children’s Anxiety Scale.

Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they score in the elevated or clinical range on the Centre for Epidemiological Studies Depression Scale for Children or if they report presence of an Autism Spectrum Disorder (ASD) or Psychotic Disorder.

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)
Allocation is concealed as the randomisation is allocated by the Momentum platform once the Baseline has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are randomised to one of the two treatment conditions by the Momentum platform. Randomisations are stratified by age (7 to 12 vs 13 to 17) and gender (male, female, other).
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
Sample size was determined using G*Power 3.1.9.7 based on the effect observed by Titov et al (2010) when they compared an Internet delivered CBT program for social anxiety with a version preceded by MI modules designed to build motivation for program engagement. MomentumPlus is expected to be at least as effective as non-imagery-based motivation enhancement. Based on an effect on program drop-out equivalent to d=0.41, a total sample of 188 is needed to achieve a power of 0.80 to detect group differences on adherence at a .05 alpha level.
Data will be collected in online format and downloaded into excel or SPSS spreadsheets for analysis. Data will be analysed using SPSS Statistics 27. A mix of univariate and multivariate tests will be employed to examine the primary and secondary hypotheses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/07/2024
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
188
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310165 0
Government body
Name [1] 310165 0
Medical Research Future Fund Research Support Scheme, Department of Health and Aged Care
Country [1] 310165 0
Australia
Primary sponsor type
Individual
Name
Dr Melanie White
Address
Centre for Children's Health Research62 Graham StSouth Brisbane, QLD 4101
Country
Australia
Secondary sponsor category [1] 311452 0
Individual
Name [1] 311452 0
Dr Jennifer Connolly
Address [1] 311452 0
School of Psychology and Counselling Queensland University of TechnologyKelvin Grove, QLD 4059
Country [1] 311452 0
Australia
Secondary sponsor category [2] 313003 0
Individual
Name [2] 313003 0
A/Prof Sanjeewa Kularatna
Address [2] 313003 0
AusHSIQueensland University of TechnologyKelvin Grove, QLD 4059
Country [2] 313003 0
Australia
Secondary sponsor category [3] 313004 0
Individual
Name [3] 313004 0
Mr Christopher Cahill
Address [3] 313004 0
School of Psychology and CounsellingQueensland University of TechnologyKelvin Grove, QLD 4059
Country [3] 313004 0
Australia
Secondary sponsor category [4] 313005 0
Individual
Name [4] 313005 0
Dr Shelley Appleton
Address [4] 313005 0
Centre for Children's Health Research62 Graham StSouth Brisbane, QLD 4101
Country [4] 313005 0
Australia
Secondary sponsor category [5] 313006 0
Individual
Name [5] 313006 0
Emer Prof David Kavanagh
Address [5] 313006 0
Centre for Children's Health Research62 Graham StSouth Brisbane, QLD 4101
Country [5] 313006 0
Australia
Secondary sponsor category [6] 313009 0
Individual
Name [6] 313009 0
Prof Sonja March
Address [6] 313009 0
University of Southern QueenslandSpringfield campusSpringfield, QLD 4300
Country [6] 313009 0
Australia
Secondary sponsor category [7] 313010 0
Individual
Name [7] 313010 0
Prof Caroline Donovan
Address [7] 313010 0
School of Applied PsychologyGriffith University 176 Messines Ridge RdMount Gravatt, QLD 4122
Country [7] 313010 0
Australia
Secondary sponsor category [8] 313011 0
Individual
Name [8] 313011 0
A/Prof Vanessa Cobham
Address [8] 313011 0
School of PsychologyThe University of QueenslandSt Lucia, QLD 4072
Country [8] 313011 0
Australia
Secondary sponsor category [9] 313012 0
Individual
Name [9] 313012 0
Prof Leanne Hides
Address [9] 313012 0
School of PsychologyThe University of QueenslandSt Lucia, QLD 407
Country [9] 313012 0
Australia
Secondary sponsor category [10] 313013 0
Individual
Name [10] 313013 0
Prof Lara Farrell
Address [10] 313013 0
School of Applied PsychologyGold Coast campusGriffith UniversityParklands DrSouthport, QLD 4222
Country [10] 313013 0
Australia
Secondary sponsor category [11] 313014 0
Individual
Name [11] 313014 0
Prof Alison Calear
Address [11] 313014 0
College of Health and MedicineCentre for Mental Health ResearchBuilding 63The Australian National UniversityCanberra, ACT 2601
Country [11] 313014 0
Australia
Secondary sponsor category [12] 313015 0
Individual
Name [12] 313015 0
Emer Prof Sue Spence
Address [12] 313015 0
School of Applied PsychologyGriffith University 176 Messines Ridge RdMount Gravatt, QLD 4122
Country [12] 313015 0
Australia
Secondary sponsor category [13] 313016 0
Individual
Name [13] 313016 0
Prof Britt Klein
Address [13] 313016 0
School of ScienceSMB campusFederation University107 Lydiard StBallarat Central, VIC 3350
Country [13] 313016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309854 0
Queensland University of Technology University Human Research Ethics Committee
Ethics committee address [1] 309854 0
Ethics committee country [1] 309854 0
Australia
Date submitted for ethics approval [1] 309854 0
07/09/2021
Approval date [1] 309854 0
09/02/2024
Ethics approval number [1] 309854 0
4518

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

Contacts
Principal investigator
Name 115618 0
Dr Melanie White
Address 115618 0
Queensland University of Technology, School of Psychology and Counselling, O Block, Kelvin Grove, QLD, 4059
Country 115618 0
Australia
Phone 115618 0
+61 07 3138 4714
Fax 115618 0
Email 115618 0
[email protected]
Contact person for public queries
Name 115619 0
Dr Jennifer Connolly
Address 115619 0
Queensland University of Technology, Centre for Children's Health Research, 62 Graham Street, South Brisbane, Queensland 4101
Country 115619 0
Australia
Phone 115619 0
+61 07 3169 7543
Fax 115619 0
Email 115619 0
[email protected]
Contact person for scientific queries
Name 115620 0
Jennifer Connolly
Address 115620 0
Queensland University of Technology, Centre for Children's Health Research, 62 Graham Street, South Brisbane, Queensland 4101
Country 115620 0
Australia
Phone 115620 0
+61 07 3169 7543
Fax 115620 0
Email 115620 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?
At this stage there are no plans to make de-identified individual participant data available. However, all de-identified individual participant data from this trial will be made available if requested.
When will data be available (start and end dates)?
The data will be available once publication occurs for a period of 5 years.
Available to whom?
Data obtained from the Momentum platform will be made available in non-identifiable format for future research purposes to researchers who obtain ethical approval and at the discretion of the principal researcher.
Available for what types of analyses?
The data will be made available for any purpose, subject to ethics approval and approval by the principal investigator.
How or where can data be obtained?
Access will be subject to ethics approval and prior approval being obtained from the principal researcher. Data can be obtained on request from Dr Jennifer Connolly 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.