Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000694617
Ethics application status
Approved
Date submitted
6/06/2023
Date registered
28/06/2023
Date last updated
28/06/2023
Date data sharing statement initially provided
28/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Rau Mahara Rongomau: Online mental health support while waiting for in-person therapy
Scientific title
Rau Mahara Rongomau: Randomised controlled trial of online cognitive behavioural therapy as an initial treatment for psychological distress in patients waiting for in-person therapy
Secondary ID [1] 309781 0
None
Universal Trial Number (UTN)
U1111-1293-2284
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 330185 0
Anxiety 330186 0
Mental distress 330187 0
Condition category
Condition code
Mental Health 327065 327065 0 0
Depression
Mental Health 327066 327066 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be patients at a primary health practice in Auckland, New Zealand, who are on the waitlist for an in-person therapy appointment for mental distress and whose first in-person appointment is at least five weeks away. When they join the waitlist, those in the intervention group will be provided with access to Just a Thought, which is a free online tool that offers evidence-based cognitive behavioural therapy courses. Just a Thought is derived from THIS WAY UP, a series of online cognitive behavioural therapy courses designed by a team of clinicians and researchers in Australia, and tested for efficacy in over 30 randomised controlled trials (see https://crufad.org/our-research/). Just a Thought purchased the licence for THIS WAY UP courses but redeveloped the content to ensure equitable accessibility and cultural responsiveness across the New Zealand population, while retaining the evidence-based cognitive behavioural therapy content. The Just a Thought courses that will be available for participants to choose from are the Depression, Generalised Anxiety Disorder, Mixed Depression and Anxiety, and Social Anxiety courses, all of which include six lessons, and the Insomnia course, which has four lessons. Participants will be instructed to choose the course that is most relevant to them. Each lesson comprises a narrative story of a fictionalised character who is experiencing a particular type of mental distress and takes approximately 30 minutes to complete. The character’s story and journey teaches psychoeducational and skill-based cognitive behavioural therapy content to the participant. Each lesson is supported by ‘homework’, which takes the information learned and supports the user to apply it to their own challenges and experiences in a worksheet format. Each set of lesson 'homework' takes approximately 60 minutes to complete. Each course has its own frequently asked questions, extra resources, and worksheets that support the user to enhance the skills and techniques outlined. Intervention group participants can go through the lessons at their own pace (i.e., no formal time restriction), but will be encouraged via regular contact from the Study Project Manager to complete one lesson per week. Participants who have not yet completed their chosen course before their first in-person therapy appointment will still be able to continue using the course once their in-person therapy sessions have started. Participants will also be able to continue to access the lessons indefinitely following their completion in the study. Intervention adherence will be monitored via website analytics that provide information on lesson engagement and completion rates.
Intervention code [1] 326220 0
Treatment: Other
Comparator / control treatment
Participants in the control group will experience waitlist-as-usual conditions plus access to a webpage that provides general mental health promotion information developed by the New Zealand Mental Health Foundation called the ‘Five Ways to Wellbeing’. Waitlist-as-usual conditions at the primary health practice running the intervention comprise contact for the purpose of appointment scheduling, the provision of information about a local peer-led mental health support group, and the provision of emergency mental health service contact information.
Control group
Active

Outcomes
Primary outcome [1] 335020 0
Mean score on the Kessler-10 psychological distress scale (K10)
Timepoint [1] 335020 0
Assessed at baseline, at 2, 3, 4, 5, 6, 8, and 10 weeks after intervention commencement, and at 8 months after intervention commencement. We will use intention-to-treat mixed models to test for a time by treatment interaction in the rate of change in K10 scores across the first ten weeks of the study (i.e., the primary endpoint will be 10 weeks after intervention commencement).
Primary outcome [2] 335025 0
Mean satisfaction score with the online tool (Just a Thought for those in the intervention group; Five Ways to Wellbeing for those in the control group). The satisfaction score will be assessed on a 10-point Likert scale: ‘On a scale of 1 to 10, how likely would you be to recommend Just a Thought [intervention group]/ the Five Ways to Wellbeing [control group] to a friend or colleague’
Timepoint [2] 335025 0
Assessed at 5 and 10 weeks after intervention commencement
5 weeks will be the primary timepoint
Primary outcome [3] 335026 0
Mean wellbeing score on the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
Timepoint [3] 335026 0
Assessed at baseline, at 2, 3, 4, 5, 6, 8, and 10 weeks after intervention commencement, and at 8 months after intervention commencement. We will use intention-to-treat mixed models to test for a time by treatment interaction in the rate of change in SWEMWBS scores across the first ten weeks of the study (i.e., the primary endpoint will be 10 weeks after intervention commencement).
Secondary outcome [1] 422749 0
Mean self-perceived need for in-person therapy score. Self-perceived need for therapy will be assessed on a 5-point Likert scale: 'Based on how you've been feeling over the last 7 days how often have you felt you needed support from a therapist?'
Timepoint [1] 422749 0
Assessed at baseline, 5 weeks, and 10 weeks after intervention commencement. We will use intention-to-treat mixed models to test for a time by treatment interaction in the rate of change in self-perceived need for therapy across these three time points.
Secondary outcome [2] 422755 0
Mean number of in-person therapy sessions attended, obtained from an audit of patient therapy attendance records.
Timepoint [2] 422755 0
Measured at 8 months after intervention commencement
Secondary outcome [3] 423274 0
Mean score on the Generalised Anxiety Disorder 7 (GAD7) scale
Timepoint [3] 423274 0
Assessed at baseline, at 2, 3, 4, 5, 6, 8, and 10 weeks after intervention commencement, and at 8 months after intervention commencement. We will use intention-to-treat mixed models to test for a time by treatment interaction in the rate of change in GAD7 scores across the first ten weeks of the study.
Secondary outcome [4] 423275 0
Mean self-rated health score, as assessed on a 4-point scale: 'How would you rate your state of health compared to others your age?'
Timepoint [4] 423275 0
Assessed at baseline, at 2, 3, 4, 5, 6, 8, and 10 weeks after intervention commencement, and at 8 months after intervention commencement. We will use intention-to-treat mixed models to test for a time by treatment interaction in the rate of change in self-rated health scores across the first ten weeks of the study.

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria:
- Referred for in-person therapy at Tamaki Health
- Aged 16 years and over
- Fluent in English
- Have at least five weeks to wait before their first in-person therapy appointment
- Have an email address
- Have access to the internet via a mobile phone or computer
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
- Have completed a Just a Thought course in the past three months; OR
- Are actively suicidal

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 will be concealed. Randomisation will occur via computer once participants complete the screening and registration forms online.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Power calculations using observed patterns of change in K10 scores from the New Zealand public’s unguided use of the Just a Thought Depression course indicate that the sample size required to have 80% power to detect a statistically significant time by treatment interaction depends on the number of lessons that those in the intervention group complete. If intervention group participants complete two lessons, a total of between 237 and 345 participants (119 to 173 in each group) is needed. If intervention group participants complete three lessons, a total of between 144 and 188 participants (72 to 94 in each group) will be needed. Given the regular contact by the study manager with participants to check in with them and encourage completion of subsequent Just a Thought lessons, we expect the majority of intervention group participants to complete three lessons, and hence have a target total sample size of 200 participants (100 in each group). To allow for a 20% attrition rate, we aim to recruit 240 participants (120 in each group).

All analyses will be conducted using a standard statistical program, such as Statistical Package for the Social Sciences (SPSS; IBM Corp., USA) or Stata (Stata corp, USA). Descriptive statistics (means and percentages) will be used to assess acceptability of Just a Thought (intervention group) or the Five Ways to Wellbeing (control group). Intention-to-treat mixed models will be used to evaluate the effectiveness of the intervention. First, we will test for a time by treatment interaction in K10 scores, GAD7 scores, SWEMWBS scores, and self-rated health to assess whether the rate of change across the first ten weeks of the study is different for those in the treatment versus intervention groups. Second, we will test for a time by treatment interaction in K10 scores, GAD7 scores, SWEMWBS scores, and self-rated health from baseline to post-treatment (8-month follow-up). Mediation and moderation analyses will be used to test how level of engagement in the intervention (i.e., number of lessons completed) and concurrent utilisation of other mental health services during the trial affected the change in scores over time. ANOVAs and/or ordinary least squares regression will be used to test for a between-group difference in people’s week 5 ratings of how much they feel they need in-person therapy, and the number of therapy sessions participants attend. For all relevant analyses, multiple imputation will be used where appropriate to account for missing data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment outside Australia
Country [1] 25583 0
New Zealand
State/province [1] 25583 0
Auckland

Funding & Sponsors
Funding source category [1] 313961 0
Charities/Societies/Foundations
Name [1] 313961 0
The Wise Group
Country [1] 313961 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315931 0
None
Name [1] 315931 0
Address [1] 315931 0
Country [1] 315931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313098 0
Central Health and Disability Ethics Committee (New Zealand)
Ethics committee address [1] 313098 0
Ethics committee country [1] 313098 0
New Zealand
Date submitted for ethics approval [1] 313098 0
05/04/2023
Approval date [1] 313098 0
28/04/2023
Ethics approval number [1] 313098 0
2023 FULL 12763

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

Contacts
Principal investigator
Name 126998 0
Prof Richie Poulton
Address 126998 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 126998 0
New Zealand
Phone 126998 0
+64 3 479 8507
Fax 126998 0
Email 126998 0
[email protected]
Contact person for public queries
Name 126999 0
Hayley Guiney
Address 126999 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 126999 0
New Zealand
Phone 126999 0
+64 3 470 4760
Fax 126999 0
Email 126999 0
[email protected]
Contact person for scientific queries
Name 127000 0
Hayley Guiney
Address 127000 0
Department of Psychology
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 127000 0
New Zealand
Phone 127000 0
+64 3 470 4760
Fax 127000 0
Email 127000 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant consent does not allow for wider availability of individual data


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.