Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000209594
Ethics application status
Approved
Date submitted
30/01/2024
Date registered
1/03/2024
Date last updated
25/07/2024
Date data sharing statement initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Developing a screening tool to predict who will benefit from online-assisted treatment for depression and anxiety among tertiary students.
Scientific title
A randomised controlled trial of online group Cognitive Behavioural Therapy (CBT), guided eCBT, and unguided eCBT for symptoms of depression and anxiety among tertiary students in Aotearoa, New Zealand
Secondary ID [1] 310865 0
Health Research Council (HRC) 23/018
Universal Trial Number (UTN)
U1111-1300-8558
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 331906 0
Anxiety 331907 0
Condition category
Condition code
Mental Health 328640 328640 0 0
Depression
Mental Health 328641 328641 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) iStandard: Online CBT-based self-guided modules, 4-12 modules

2) iCoach: The same online CBT-based self-guided modules as delivered in iStandard with the same instructions but with the addition of asynchronous, text-based coach support,

For iStandard and iCoach, participants can select from among the same modules to suit their needs. Modules are transdiagnostic "bundled" by theme to address common student challenges: (1) Stress; 2) Mood; 3) Life skills including self-esteem, emotional wellbeing, study skills, and social life; 4) Procrastination; 5) Self-esteem. Bundles contain 4-12 modules. Module content includes stress management, whai tikanga, cognitive restructuring, behavioural activation, assertiveness, sleep, exercise, problem solving, procrastination and time management, instant relaxation techniques, goal setting, and breathing exercises. The programmes use videos, text, and infographics. Participants are asked to write about their emotional, cognitive, and behavioural responses and coping strategies as they work through the modules. Each session lasts approximately 60 minutes and participants are advised to complete one module every week but they are able to complete them at their discretion. In iCoach, after each module, a coach provides asynchronous feedback on-line. Students are also able to write messages to their coach. Coach support is available for three months from enrollment; module content for iStandard and iCoach is available for 12 months from enrollment. The online platform sends personalised reminders to participants to complete sessions if they have not engaged within the past fortnight. The platform is optimised for use on either smart phones or personal computers. Technical support will be available through email and phone support, which improves adherence. Module completion will be recorded to monitor adherence. Module content was developed by our collaborators in the Netherlands at Vrije University Amsterdam and adapted by our research team, for this study, for use in Aotearoa NZ.

3) iGroup: Online CBT-based psychological skills groups,
Five 2 hour modules (delivered weekly over 10 weeks in 60 minute sessions via Zoom) covering:
1.1 Emotional triggers and automatic thoughts
1.2 Challenge automatic thoughts and core beliefs
2.1 Recognise stressors and use strategies to solve interpersonal and emotional problems
2.2 Goal setting and planning
3.1 Avoiding thinking traps
3.2 Overcoming rumination and guilt
4.1 Behaviour activation
4.2 Whai tikanga and behaviours that matter
5.1 The body’s stress response and how to use strategies to regulate physiological arousal
5.2 Managing stress and overcoming avoidance

Group participants are provided with a workbook, which covers the content covered in the interactive group session. Participants are able to keep their camera turned off and use a pseudonym during the session for anonymity, but are encouraged to turn their camera on as they become comfortable. Information is presented by the group facilitator and then participants are asked questions, which they can discuss with other group members in a break-out room or with the whole group depending on the size of the group and the nature of the questions. For example, in Workshop A.1 Emotional Triggers and Automatic Thoughts, participants are asked to consider and then discuss what they think can cause depression and anxiety, what causes are easy to change, how do people interact with others when they are feeling sad or anxious - how do the feelings affect their behaviour, Information is then presented by the facilitator about the thoughts, feelings, behaviours triangle, Next a case scenario is presented for the participants to consider and to discuss the thoughts the person in the case might have and then how that might affect the person's feelings. At the end of the session, participants are encouraged to keep a daily record of their thoughts and feelings over the coming week.

The group content was created by our collaborators in South Africa and adapted for use in this study.

Group facilitators will have completed the 5th year of a Clinical Psychology training programme and will be supervised by a registered clinical psychologist.
Group attendance will be recorded to monitor adherence. Group size will not exceed 12 participants.
Every treatment arm is targeted to the treatment of depression and anxiety symptoms and all content was developed considering the specific needs of student participants e.g., case study examples are students with common student challenges.
Intervention code [1] 327324 0
Treatment: Other
Comparator / control treatment
Treatment as usual (TAU): participants will be randomised to TAU and sent an email containing information about their Student Health and Counselling service and advised to make an appointment at the student service or with their GP if their GP is not at the Student Health and Counselling service. Contact information for the local student service will be included in the information email.
Control group
Active

Outcomes
Primary outcome [1] 337244 0
Depression
Timepoint [1] 337244 0
Baseline; 3- (primary timepoint), 6-, and 12 months post intervention commencement.
Primary outcome [2] 337245 0
Anxiety
Timepoint [2] 337245 0
Baseline; 3- (primary timepoint), 6-, and 12 months post intervention commencement.
Secondary outcome [1] 431209 0
Impairment due to mental health
Timepoint [1] 431209 0
Baseline, 3-,6-, and 12-months post intervention commencement

Eligibility
Key inclusion criteria
At least 18 years of age, screens positive for major depressive disorder and/or generalized anxiety disorder, student enrolled in one of the participating tertiary sites
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Screens positive for bipolar disorder, screens positive for psychosis, active suicidality

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Baseline survey results will be used to stratify randomization of eligible patients across study arms. This will be done automatically within the Qualtrics survey platform using the 4-way cross-classification of sex at birth, ethnicity, depression symptom severity and anxiety symptom severity.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Using a sequential multiple assignment randomised trial (SMART) design, participants will still complete the intervention in parallel assignment but at the 3 month follow-up, all participants in an active treatment arm (unguided, guided, and group) who still meet the inclusion criteria for symptoms of depression and anxiety will be re-randomised to one of the three treatment arms (unguided, guided, and group) whereby 33% of participants will be offered maintenance of their original treatement and the others will be offered a novel treatment option.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Aggregate differences in outcomes across arms will be estimated using an intent-to-treat (ITT) analysis approach as well as using a complier average causal effect (CACE) analysis approach.

Analysis of heterogeneity of treatment intervention effects will be undertaken using an ensemble machine learning approach.

We powered the study to estimate heterogeneity of treatment effects, as defined by a 5% increase in the proportion of patients who would be expected to remit based on optimised rather than randomised treatment. We determined that a 5% increase would be the minimum difference of interest (i.e., if 30% of participants remit following random allocation, we would expect 35% of participants to remit under optimised allocation). Although we will be interested in continuous (i.e., differences in mean scores on symptom rating scales) and categorical (i.e., probabilities of treatment response and remission) scores, we evaluated statistical power for a categorical measure of episode remission because this is of greater clinical importance than continuous outcome scores and because larger samples are required for powerful detection of effects on categorical than continuous outcomes. Estimating power to detect heterogeneity of treatment effects is complex because closed-form solutions do not exist, and simulation is needed to determine required sample sizes. Simulations for required sample size demonstrated that adequate power (i.e., .8 power based on .05-level two-sided tests) to detect 5% improvement over random allocation would require a sample of 300-500 patients per treatment arm depending on the amount of noise (i.e., variables included in the predictor set that are not significant prescriptive predictors) and the complexity of the specification (i.e., it is easier to detect a true effect due to one very large interaction than an effect of comparable size due to the combined effects of a number of smaller interactions). Based on this result we designed the study to have a sample size of 500 per treatment arm.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/03/2024
Actual
21/03/2024
Date of last participant enrolment
Anticipated
1/09/2025
Actual
Date of last data collection
Anticipated
1/10/2026
Actual
Sample size
Target
2000
Accrual to date
101
Final
Recruitment outside Australia
Country [1] 26125 0
New Zealand
State/province [1] 26125 0

Funding & Sponsors
Funding source category [1] 315125 0
Government body
Name [1] 315125 0
Health Research Council
Country [1] 315125 0
New Zealand
Primary sponsor type
University
Name
University of otago
Address
Country
New Zealand
Secondary sponsor category [1] 317139 0
None
Name [1] 317139 0
Address [1] 317139 0
Country [1] 317139 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314061 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 314061 0
Ethics committee country [1] 314061 0
New Zealand
Date submitted for ethics approval [1] 314061 0
07/06/2022
Approval date [1] 314061 0
08/07/2022
Ethics approval number [1] 314061 0
H22/079

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

Contacts
Principal investigator
Name 130274 0
Dr Charlene Rapsey
Address 130274 0
Department of Psychological Medicine, 464 Cumberland St, Fraser Building, 2nd Floor, Dunedin 9016
Country 130274 0
New Zealand
Phone 130274 0
+64 220657707
Fax 130274 0
Email 130274 0
charlene.rapsey@otago.ac.nz
Contact person for public queries
Name 130275 0
Charlene Rapsey
Address 130275 0
Department of Psychological Medicine, 464 Cumberland St, Fraser Building, 2nd Floor, Dunedin 9016
Country 130275 0
New Zealand
Phone 130275 0
+64 220657707
Fax 130275 0
Email 130275 0
charlene.rapsey@otago.ac.nz
Contact person for scientific queries
Name 130276 0
Charlene Rapsey
Address 130276 0
Department of Psychological Medicine, 464 Cumberland St, Fraser Building, 2nd Floor, Dunedin 9016
Country 130276 0
New Zealand
Phone 130276 0
+64 220657707
Fax 130276 0
Email 130276 0
charlene.rapsey@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data collected during the trial.
When will data be available (start and end dates)?
Beginning 12 months following initial publication and ending 7 years from the end of data collection.
Available to whom?
Researchers who provide a methodologically sound proposal and meet requirements of Maori data sovereignty.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator, charlene.rapsey@otago.ac.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21525Study protocol  charlene.rapsey@otago.ac.nz
21526Statistical analysis plan  charlene.rapsey@otago.ac.nz
21528Ethical approval  charlene.rapsey@otago.ac.nz 386804-(Uploaded-29-02-2024-10-47-26)-Study-related document.pdf
21529Data dictionary  charlene.rapsey@otago.ac.nz
21662Informed consent form  charlene.rapsey@otago.ac.nz



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.