Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000670774
Ethics application status
Approved
Date submitted
19/04/2022
Date registered
9/05/2022
Date last updated
16/06/2023
Date data sharing statement initially provided
9/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the effectiveness of a digital psychological intervention in people with Multiple Sclerosis attending the Multiple Sclerosis Clinic at Royal North Shore Hospital.
Scientific title
Examining the effect of the Wellbeing Neuro Course on symptoms of depression, anxiety and disability in patients with Multiple Sclerosis at Multiple Sclerosis Clinic-Royal North Shore Hospital (MSC-RNSH)
Secondary ID [1] 306900 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 326003 0
Depression 326004 0
Anxiety 326005 0
Disability 326006 0
Cognitive difficulties 326007 0
Fatigue 326008 0
Condition category
Condition code
Mental Health 323311 323311 0 0
Depression
Mental Health 323312 323312 0 0
Anxiety
Neurological 323313 323313 0 0
Multiple sclerosis

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] 323349 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331045 0
Depression symptoms will be assessed using the widely used validated Patient Health Questionnaire 9-Item (PHQ9)
Timepoint [1] 331045 0
Pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks postcommencement), 3-months post-treatment. The primary endpoint is post-treatment.
Primary outcome [2] 331046 0
Anxiety symptoms will be assessed using the well-validated Generalized Anxiety Disorder Scale 7-Item (GAD-7)
Timepoint [2] 331046 0
Pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks postcommencement), 3-months post-treatment. The primary endpoint is post-treatment.
Primary outcome [3] 331047 0
World Health Organization Disability Assessment Schedule 2.0 12-Item (WHODAS-12). This is a measure that assesses health and disability, which is applicable to a variety of disability domains, including neurological, mental, and chronic physical conditions
Timepoint [3] 331047 0
Pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks postcommencement), 3-months post-treatment. The primary endpoint is post-treatment.
Secondary outcome [1] 408580 0
Neuro-QoL (Quality of Life in Neurological Disorders) is a measurement system that evaluates and monitors the physical, mental, and social effects experienced by adults and children living with neurological conditions. The following subscales will be administered.
Neuro-QoL (Cognitive Function)
Neuro-QoL (Emotional and Behavioural Dyscontrol)
Timepoint [1] 408580 0
Pre-treatment, mid-treatment (Neuro-QoL cognitive function only), post-treatment (10 weeks postcommencement), 3-months post-treatment.
Secondary outcome [2] 408581 0
Compensatory Cognitive Strategies Questionnaire (CCSQ). This is a purpose built measure to assess the use of compensatory cognitive strategies before and after the intervention.
Timepoint [2] 408581 0
Pre-treatment, mid-treatment, post-treatment, 3 month follow up
Secondary outcome [3] 408582 0
Fatigue Severity Scale (FSS). This is a measure of the severity of fatigue and it’s impact on a person’s activities and lifestyle in patients with a variety or chronic health disorders
Timepoint [3] 408582 0
Pre-treatment, post-treatment, 3 month follow up.
Secondary outcome [4] 408583 0
Treatment Satisfaction Questionnaires (TSQ), which measures the acceptability of online treatment Courses and participants’ satisfaction with treatment.
Timepoint [4] 408583 0
post-treatment, 3-month follow up
Secondary outcome [5] 409240 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 [5] 409240 0
Post-treatment.
Secondary outcome [6] 409241 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 [6] 409241 0
3- post-treatment follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria include: (a) Patient at the Royal North Shore Hospital Multiple Sclerosis Clinic with 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
Exclusion criteria include (a) immediately suicidal or unable to keep themselves safe; (b) severe cognitive impairment (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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
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 (Cook, Julious, Sones, Hampson, Hewitt, Berlin, Vale & 2018), pilot data from a comparable clinical trial (Gandy et al., 2020) was used to determine that sample of 90 is sufficiently powered to refute differences in the rate primary outcome change that are as small as 11% from pre to post treatment. This estimation was calculated with specialised longitudinal power analysis software (Donohue, Gamst, Edland, & Donohue, 2013), under commonly used error thresholds with alpha set at 0.05 and power set at .80. However, in order to hedge against potential attrition and allow for sensitivity analysis we aimed to recruit 120 participants.

Cook, J. A., Julious, S. A., Sones, W., Hampson, L. V., Hewitt, C., Berlin, J. A., ... & Vale, L. D. (2018). DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial. bmj, 363.

Donohue, M. C., Gamst, A. C., Edland, S. D., & Donohue, M. M. C. (2013). Package ‘longpower’. Biometrics, 53(3), 937-47.

Gandy, M. Karin, E., McDonald, S., Meares, S., Scott,M., Titov, N., Dear, B.F. (2020). A feasibility trial of an internet-delivered psychological intervention to manage mental health and functional outcomes in neurological disorders. Journal of Psychosomatic Research. 136.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
9/06/2023
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
31/01/2025
Actual
Sample size
Target
120
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 22185 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 37339 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 311259 0
Charities/Societies/Foundations
Name [1] 311259 0
MS Australia
Country [1] 311259 0
Australia
Funding source category [2] 311260 0
University
Name [2] 311260 0
Macquarie University
Country [2] 311260 0
Australia
Primary sponsor type
Individual
Name
Dr Milena Gandy
Address
School of Psychological Sciences
Balaclava Road, North Ryde
Macquarie University NSW 2109
Country
Australia
Secondary sponsor category [1] 312617 0
Individual
Name [1] 312617 0
Dr Vincent Oxenham
Address [1] 312617 0
Multiple Sclerosis Clinic
Reserve Rd, St Leonards NSW 2065
Country [1] 312617 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310741 0
Northern Sydney Local Health District Human Research Ethics Executive Committee
Ethics committee address [1] 310741 0
Ethics committee country [1] 310741 0
Australia
Date submitted for ethics approval [1] 310741 0
01/03/2022
Approval date [1] 310741 0
11/04/2022
Ethics approval number [1] 310741 0
2022/ETH00362
Ethics committee name [2] 312511 0
Royal North Shore Hospital
Ethics committee address [2] 312511 0
Ethics committee country [2] 312511 0
Australia
Date submitted for ethics approval [2] 312511 0
09/09/2022
Approval date [2] 312511 0
24/10/2022
Ethics approval number [2] 312511 0
2022/STE03128

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

Contacts
Principal investigator
Name 118706 0
Dr Milena Gandy
Address 118706 0
School of Psychological Sciences
Balaclava Road, North Ryde
Macquarie University
NSW 2109
Country 118706 0
Australia
Phone 118706 0
+61 2 98504152
Fax 118706 0
Email 118706 0
[email protected]
Contact person for public queries
Name 118707 0
Vincent Oxenham
Address 118707 0
L3 Acute Services Building, Neurology Department, Royal North Shore Hospital, Sydney, Australia
Country 118707 0
Australia
Phone 118707 0
+61 2 94631826
Fax 118707 0
Email 118707 0
[email protected]
Contact person for scientific queries
Name 118708 0
Milena Gandy
Address 118708 0
School of Psychological Sciences
Balaclava Road, North Ryde
Macquarie University
NSW 2109
Country 118708 0
Australia
Phone 118708 0
+61 298504152
Fax 118708 0
Email 118708 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?
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 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?
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 Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Email investigator ([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.