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Trial registered on ANZCTR


Registration number
ACTRN12620000165987
Ethics application status
Approved
Date submitted
31/01/2020
Date registered
17/02/2020
Date last updated
17/02/2020
Date data sharing statement initially provided
17/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the efficacy of an Online Cognitive Behaviour Therapy (CBT) - based self-management Program for Adults with Neurological Disorders.
Scientific title
The Wellbeing Neuro Course: Examining the Efficacy of an Online Treatment Program for Adults with Neurological Disorders
Secondary ID [1] 300256 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 315815 0
Anxiety 315816 0
Quality of Life 315817 0
Cognitive difficulties 315818 0
Epilepsy 315819 0
Multiple Sclerosis 315820 0
Parkinson's disease 315821 0
Acquired Brain Injury 315822 0
Stroke 315823 0
Disability 315824 0
Condition category
Condition code
Mental Health 314106 314106 0 0
Depression
Mental Health 314107 314107 0 0
Anxiety
Neurological 314108 314108 0 0
Epilepsy
Neurological 314109 314109 0 0
Multiple sclerosis
Neurological 314110 314110 0 0
Parkinson's disease
Neurological 314111 314111 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions, the Wellbeing Neuro Course, is an internet-delivered self-management program. It was developed at the eCentreClinic specifically for this body of research. 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.
(b) Worksheets for each lesson.
(c) 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.
(d) Case stories based on previous participants, which they can follow throughout the Course.
(e) Brief weekly contact with a psychologist via secure email or telephone.

Participants will be encouraged to complete a lesson every 10 days and complete some basic homework 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 each week to monitor their mood and progress through the Course; each eCentreClinic Psychologist receives 1 hour or more of weekly supervision from another eCentreClinic Psychologist in which all of their participants are reviewed; as per best-practice guidelines and eCentreClinic Policy.

The Wellbeing Neuro Course is based on cognitive behaviour therapy (CBT) principles and teaches evidence-based skills for managing the impacts of neurological conditions 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. Telephone calls will be limited to approximately 10 minutes per week; however, more time will be provided where clinically indicated. Adherence (e.g., logins, lesson completion, lesson views, time spent on course) will be monitored via the eCentreClinic software, which is used to provide the Wellbeing Neuro Course.
Intervention code [1] 316525 0
Behaviour
Intervention code [2] 316526 0
Rehabilitation
Comparator / control treatment
A Waitlist Control Group will be utilised. The Waitlist Control Group will receive the same treatment after the Active Treatment Group has completed the 10-week Course.

Control group
Active

Outcomes
Primary outcome [1] 322495 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 [1] 322495 0
Application, pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Primary outcome [2] 322496 0
Patient Health Questionnaire 9-Item (PHQ9) and Neurological Depressive Disorders Inventory - Epilepsy, which are two measures of depression.
Timepoint [2] 322496 0
Application (just PhQ9), pre-treatment, mid-treatment ( 5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Primary outcome [3] 322497 0
Generalized Anxiety Disorder 7-Item (GAD7) and Brief Epilepsy Anxiety Instrument (brEASI). which are two measuresof anxiety.
Timepoint [3] 322497 0
Application (just GAD-7) pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Secondary outcome [1] 378713 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.
o Neuro-QoL (Cognitive Function)
o Neuro-QoL (Positive Affect and Wellbeing
o Neuro-QoL (Emotional and Behavioural Dyscontrol)
Timepoint [1] 378713 0
Pre-treatment, post-treatment, 3 month follow-up
Secondary outcome [2] 378714 0
Treatment Satisfaction Questionnaires (TSQ), which measures the acceptability of online treatment Courses and participants’ satisfaction with treatment.
Timepoint [2] 378714 0
post-treatment, 3 month follow-up.
Secondary outcome [3] 379344 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 [3] 379344 0
Pre-treatment, mid-treatment, post-treatment, 3 month follow up

Eligibility
Key inclusion criteria
Inclusion criteria include: (a) Diagnosis of Multiple Sclerosis, Epilepsy, Parkinson’s Disease, Stroke, Traumatic Brain Injury or Acquired Brain Injury by a GP or specialist (b) reporting that the neurological disorder affects their cognitive and emotional health, (c) 18+ years of age, (d) Living in Australia, (e) provide informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include: (a) inability to use a computer, (b) very severe depressive symptoms indicative of >25 on the PhQ-9; (c) significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 on the PHQ-9); (d) acutely suicidal or recent history of attempted suicide or self-harm, (e) Not being under medical management for their neurological disorder, (f) serious cognitive impairment (<21 on the Telephone Interview of Cognitive Status; TICS) indicative of dementia.

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 apply online via the clinic's website (www.ecentreclinic.org.au). Successful applications are followed by a telephone interview to confirm suitability for the trial. Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
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 and with missing data being imputed.

It is expected that secondary auxiliary analyses will also be conducted accounting for the impact of baseline symptom severity on clinical outcomes and impact of treatment adherence on outcomes. Subgroup analyses are also expected to be carried out to explore the efficacy and acceptability of the intervention for participants with different neurological disorders.

Longitudinal power analyses indicate that the proposed 100:100 (N = 200) design is powered to detect differences between groups that are as small as 10%-18% on symptom/functioning measures. These analyses imply that our proposed design is statistically sensitive enough to test for subtle clinical differences between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 304681 0
University
Name [1] 304681 0
Macquarie University
Address [1] 304681 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Country [1] 304681 0
Australia
Funding source category [2] 304685 0
Commercial sector/Industry
Name [2] 304685 0
Lifetime care and support authority -icare
Address [2] 304685 0
321 Kent St, Sydney NSW 2000
Country [2] 304685 0
Australia
Primary sponsor type
University
Name
Department of Psychology, Macquarie University
Address
Department of Psychology
Building C3A
Balaclava Road, North Ryde
Macquarie University
NSW 2109
Country
Australia
Secondary sponsor category [1] 304994 0
University
Name [1] 304994 0
Macquarie University
Address [1] 304994 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Country [1] 304994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305102 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 305102 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, North Ryde, NSW, 2109.
Ethics committee country [1] 305102 0
Australia
Date submitted for ethics approval [1] 305102 0
18/11/2019
Approval date [1] 305102 0
09/12/2019
Ethics approval number [1] 305102 0
52019614512585

Summary
Brief summary
The purpose of the proposed project is to examine the acceptability and efficacy of a low-intensity CBT-based self-management program, the Wellbeing Neuro Course to support the emotional wellbeing of adults with neurological disorders. The Course contains a 6-lesson 10-week internet delivered program. Participants will have brief weekly contact with a psychologist as they work through the Course.

A two-group CONSORT-R Compliant randomised controlled trial (RCT) design will be employed, where participants are randomised to one of two groups:

1. Treatment Group (n = 100)
2. Waitlist Control Group (n = 100)

Participants in the Active Treatment Group will receive full access to the Wellbeing Neuro Course. Participants are asked to complete standardised questionnaires at 4 main time points: Pre-treatment, mid-treatment, post-treatment, and 3-month follow-up. The Waitlist Control Group will receive the same treatment after the Active Treatment Group has completed the 10-week Course
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99274 0
Dr Milena Gandy
Address 99274 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 99274 0
Australia
Phone 99274 0
+61298504152
Fax 99274 0
Email 99274 0
milena.gandy@mq.edu.au
Contact person for public queries
Name 99275 0
Dr Milena Gandy
Address 99275 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 99275 0
Australia
Phone 99275 0
+61298504152
Fax 99275 0
Email 99275 0
milena.gandy@mq.edu.au
Contact person for scientific queries
Name 99276 0
Dr Milena Gandy
Address 99276 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 99276 0
Australia
Phone 99276 0
+61298504152
Fax 99276 0
Email 99276 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?
IPD that underlie the results reported in the article, after de-identification.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following article publication.
Available to whom?
Researchers from organisations with appropriate research governance and whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Available for what types of analyses?
For IPD meta-analysis.
How or where can data be obtained?
Proposal should be direct to milena.gandy@mq.edu.au. To gain access, data requests will be subject to Australian Human Research Ethics Committee Approval and the establishment of an acceptable data sharing agreement.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6426 0
Ethical approval
Citation [1] 6426 0
Link [1] 6426 0
Email [1] 6426 0
Other [1] 6426 0
Summary results
No Results