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Trial registered on ANZCTR


Registration number
ACTRN12622000736741
Ethics application status
Approved
Date submitted
3/05/2022
Date registered
23/05/2022
Date last updated
16/06/2024
Date data sharing statement initially provided
23/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Wellbeing Neuro Course: A Randomised Controlled Trial of an Online Treatment Program for Adults with Multiple Sclerosis
Scientific title
Examining the effect of the Wellbeing Neuro Course on symptoms of depression, anxiety and disability in patients with Multiple Sclerosis.
Secondary ID [1] 307017 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 326142 0
Depression 326143 0
Anxiety 326144 0
Condition category
Condition code
Neurological 323461 323461 0 0
Multiple sclerosis
Mental Health 323462 323462 0 0
Anxiety
Mental Health 323463 323463 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions, the Wellbeing Neuro Course, is an internet-delivered psychological intervention developed at the eCentreClinic. It consists of:
(a) 6 online lessons provided over 10 weeks. The Lessons will include information about identifying symptoms of poor wellbeing including mental health and cognitive difficulties, and teach practical skills for their self- management including; managing thoughts, low mood and anxiety, problem solving, memory and attention, and activity and fatigue levels. The intervention includes guidance and examples on how to adopt core psychological skills into one’s day-to-day life, including three comprehensive case stories of adults with neurological disorders
(b) Optional worksheets for each lesson to aid the practice of core skills. Participants are strongly encouraged but not required to complete these worksheets throughout the course.
(c) Optional additional written resources, which include information about other important skills, such as problem solving common cognitive difficulties, assertiveness and communication skills and techniques for managing sleep difficulties. Participants are encouraged but not required to read through these relevant written resources.
(e) The option of brief contact with a psychologist via secure email or telephone throughout the course.
Participants will be encouraged to complete a lesson every 10 days and complete some basic home based activities in the following 10 days. All lessons can be downloaded and printed. Participants are encouraged to complete the course with a support person if available (e.g., partner, carer). Participants will be contacted by a psychologist throughout the course to monitor their progress through the Course; Psychologists from the Multiple Sclerosis Clinic at the Royal North Shore Hospital will receive weekly supervision from a Senior Clinical Psychologist at eCentreClinic Psychologist in which participants are reviewed; as per best-practice guidelines.

The Wellbeing Neuro Course is based on cognitive behaviour therapy (CBT) principles and teaches evidence-based skills for managing the impacts of neurological disorders on day-to-day activities and overall mental health. Each lesson takes between 10 and 20 minutes to complete and it is suggested that participants read each lesson at least twice and spend approximately 4 hours, across the week, practicing the skills taught. Adherence (e.g., lesson completion, lesson views) will is monitored via the eCentreClinic software, which is used to provide the Wellbeing Neuro Course.
Intervention code [1] 323465 0
Treatment: Other
Comparator / control treatment
There will be a Treatment-as-usual Waitlist Control (TAU-WLC) group (n=60) which will receive full access to the treatment after the Treatment Group finishes the Wellbeing Neuro Course. Participants in the TAU-WLC group will continue to receive their normal treatment and care from their regular health practitioners and general use of the health-care system prior to partaking in the Wellbeing Neuro Course. After the Treatment Group has finished the Wellbeing Neuro Course (i.e., 11 weeks post-intervention commencement), participants in the TAU-WLC group will be able to start receiving the intervention.
Control group
Active

Outcomes
Primary outcome [1] 331203 0
Patient Health Questionnaire 9-Item (PHQ-9), which is a measure of depression.
Timepoint [1] 331203 0
Baseline (pre-intervention), and 6 weeks (mid-intervention), 11 weeks (post-intervention/ primary endpoint), as well as at 3- and 12-months post-intervention commencement.
Primary outcome [2] 331204 0
Generalized Anxiety Disorder 7-Item (GAD-7), which is a measure of anxiety.
Timepoint [2] 331204 0
Baseline (pre-intervention), and 6 weeks (mid-intervention), 11 weeks (post-intervention/ primary endpoint), as well as at 3- and 12-months post-intervention commencement.
Primary outcome [3] 331205 0
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS-2), which is a measure of disability associated with living with a chronic health condition.
Timepoint [3] 331205 0
Baseline (pre-intervention), and 6 weeks (mid-intervention), 11 weeks (post-intervention/ primary endpoint), as well as at 3- and 12-months post-intervention commencement.
Secondary outcome [1] 409170 0
Neuro-QoL (Quality of Life in Neurological Disorders): Cognitive Function, which is a measure of perceived difficulties in cognitive abilities (e.g., attention, memory and decision making, or in the application of such abilities to everyday tasks)
Timepoint [1] 409170 0
Baseline (pre-intervention), and 6 weeks (mid-intervention), 11 weeks (post-intervention), as well as at 3- and 12-months post-intervention commencement.
Secondary outcome [2] 409171 0
Neuro-QoL (Quality of Life in Neurological Disorders): Emotional and Behavioural Dyscontrol, which is a measure of irritability, disinhibition, emotional lability, impatience and impulsivenenss.
Timepoint [2] 409171 0
Baseline (pre-intervention), 11 weeks (post-intervention), as well as at 3- and 12-months post-intervention commencement.
Secondary outcome [3] 409172 0
Fatigue Severity Scale (FSS), which is a measure of the severity of fatigue and its impact on a person’s activities and lifestyle in patients with a variety or chronic health disorders
Timepoint [3] 409172 0
Baseline (pre-intervention), 11 weeks (post-intervention), as well as at 3- and 12-months post-intervention commencement.
Secondary outcome [4] 409173 0
Compensatory Cognitive Strategies Questionnaire (CCSQ), which is a measure of the use of compensatory cognitive strategies before and after the intervention.
Timepoint [4] 409173 0
Baseline (pre-intervention), and 6 weeks (mid-intervention), 11 weeks (post-intervention), as well as at 3- and 12-months post-intervention commencement.
Secondary outcome [5] 409174 0
Treatment Satisfaction Questionnaires (TSQ), which is a purpose-built measure of the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.
Timepoint [5] 409174 0
11 weeks post-intervention commencement.
Secondary outcome [6] 409175 0
During Therapy Questionnaire (DTQ), which is a purpose-built measure to record additional therapy and changes to medication participants may have experienced during the therapy.
Timepoint [6] 409175 0
11 weeks post-intervention commencement.
Secondary outcome [7] 409176 0
Skills Use questionnaire, which is a brief, purpose-built measure to understand if participants are still using skills, and what skills, at follow-up
Timepoint [7] 409176 0
3- and 12-months post-intervention commencement.

Eligibility
Key inclusion criteria
(a) Confirmed diagnosis of Multiple Sclerosis
(b) Experiencing difficulties with their emotional and/or cognitive health
(c) 18+ years of age
(d) Living in Australia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Imminently suicidal or unable to keep themselves safe
(b) Are experiencing severe cognitive difficulties with day-to-day memory, attention and ability to learn basic information.
(c) Are unable to read and understand English
(d) Do not have access to the internet

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)
Participants who wish to apply for the treatment will do so via the clinic's website (www.ecentreclinic.org.au) and will be followed-up with a telephone interview to confirm their suitability for the trial. Importantly, the allocation sequence will be concealed from study personnel who determine participant eligibility and enrollment. These personnel will only have access to the allocation sequence after participants are successfully enrolled into the trial. Concealment will occur through visibly 'blacking-out' columns in Excel which will hide the group allocation of the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised 1:1 to immediate treatment and wait-list control. Randomisation will occur using a computer-generated randomisation sequence (using www.random.org) by an independent researcher not involved in the recruitment of participants. This sequence will be generated prior to enrolment of the first participant, which ensures that the research team are unable to affect group allocation.
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
All analyses will be carried out using conservative intention-to-treat principles.

Primary analyses of symptom outcomes will carried out employing longitudinal Generalised Estimation Equation (GEE) modelling. Missing data will be imputed using GEE accounting for individuals initial scores across the outcomes and adherence.

Subgroup analyses are expected to be carried out to explore the efficacy and acceptability of the intervention based on participants symptoms severity on the primary outcomes.

In line with clinical guidelines for sample size estimation, pilot data from a comparable clinical trial was used to determine that sample of 60 in each arm (n =120) is sufficiently powered to refute differences in the rate of pre-post primary outcome of approximately 20% (as seen in previous trials) between the groups. This estimation was calculated under commonly used error thresholds with alpha set at 0.05 and power set at .80.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2022
Actual
8/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 311326 0
Charities/Societies/Foundations
Name [1] 311326 0
MS Australia
Country [1] 311326 0
Australia
Funding source category [2] 311330 0
University
Name [2] 311330 0
Macquarie University
Country [2] 311330 0
Australia
Primary sponsor type
Individual
Name
Dr. Milena Gandy
Address
School of Psychological Sciences,
Balaclava Road, North Ryde
Macquarie University,
NSW, 2109,
Australia
Country
Australia
Secondary sponsor category [1] 312706 0
University
Name [1] 312706 0
Macquarie University
Address [1] 312706 0
Balaclava Road, Macquarie Park,
Macquarie University.
NSW, 2109
Country [1] 312706 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310827 0
Macquarie University Medical Sciences Human Research Ethics Committee (MQ HREC)
Ethics committee address [1] 310827 0
Ethics committee country [1] 310827 0
Australia
Date submitted for ethics approval [1] 310827 0
19/04/2022
Approval date [1] 310827 0
26/05/2022
Ethics approval number [1] 310827 0
520221149337544

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

Contacts
Principal investigator
Name 119006 0
Dr Milena Gandy
Address 119006 0
School of Psychological Sciences,
Balaclava Road, North Ryde
Macquarie University.
NSW, 2109
Country 119006 0
Australia
Phone 119006 0
+61 2 9850 4152
Fax 119006 0
Email 119006 0
milena.gandy@mq.edu.au
Contact person for public queries
Name 119007 0
Milena Gandy
Address 119007 0
School of Psychological Sciences,
Balaclava Road, North Ryde
Macquarie University.
NSW, 2109
Country 119007 0
Australia
Phone 119007 0
+61 2 9850 4152
Fax 119007 0
Email 119007 0
milena.gandy@mq.edu.au
Contact person for scientific queries
Name 119008 0
Milena Gandy
Address 119008 0
School of Psychological Sciences,
Balaclava Road, North Ryde
Macquarie University.
NSW, 2109
Country 119008 0
Australia
Phone 119008 0
+61 2 9850 4152
Fax 119008 0
Email 119008 0
milena.gandy@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
When will data be available (start and end dates)?
Data will be made available after any original reports have been published. There will be no end date to the availability.
Available to whom?
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Available for what types of analyses?
Any analyses required to verify the outcomes reported in published reports.
How or where can data be obtained?
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator (milena.gandy@mq.edu.au)


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.