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Trial registered on ANZCTR


Registration number
ACTRN12617000581369
Ethics application status
Approved
Date submitted
13/04/2017
Date registered
26/04/2017
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the Feasibility of an Online Cognitive Behaviour Therapy (CBT) - based self-management Program for Adults with Neurological Conditions.
Scientific title
The Wellbeing Neuro Course: Examining the Feasibility of an Online Cognitive Behaviour Therapy (CBT) - based self-management Program for Adults with Neurological Conditions.
Secondary ID [1] 290940 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 301667 0
Executive difficulties 301668 0
Multiple Sclerosis 301669 0
Anxiety 302937 0
Memory difficulties 302938 0
Epilepsy 302939 0
Traumatic Brain Injury 302940 0
Stroke 302941 0
Condition category
Condition code
Mental Health 301371 301371 0 0
Anxiety
Mental Health 301372 301372 0 0
Depression
Neurological 301374 301374 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The interventions, the Wellbeing Neuro Course, is an internet-delivered self-management program, which 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 that can be downloaded, 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. 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] 296879 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300768 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] 300768 0
Application, pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Primary outcome [2] 300769 0
Patient Health Questionnaire 9-Item (PHQ9), which is a measure of depression.
Timepoint [2] 300769 0
Application, pre-treatment, mid-treatment ( 5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Primary outcome [3] 300770 0
Generalized Anxiety Disorder 7-Item (GAD7), which is a measure of anxiety.
Timepoint [3] 300770 0
Application, pre-treatment, mid-treatment (5 weeks post commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Secondary outcome [1] 330817 0
Perceived Deficits Questionnaire (PDQ), which is a measure of cognitive difficulties.
Timepoint [1] 330817 0
Pre-treatment, mid-treatment (post-commencement), post-treatment (10 weeks post commencement), 3-months post-treatment.
Secondary outcome [2] 330818 0
Fatigue Severity Scale (FSS), which is a measure of the severity of fatigue.
Timepoint [2] 330818 0
Pre-treatment, mid-treatment (5 weeks post commencement) post-treatment (10 weeks post commencement), 3 month post-treatment.
Secondary outcome [3] 330820 0
Treatment Satisfaction Questionnaire (TSQ), which is a purpose built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.
Timepoint [3] 330820 0
Post-treatment (10 weeks post commencement)

Eligibility
Key inclusion criteria
-Confirmed diagnosis of a neurological condition; Multiple Sclerosis, Epilepsy, Parkinson’s Disease, Stroke, Traumatic Brain Injury or Acquired Brain Injury.
- Experiencing cognitive difficulties (e.g., difficulties with memory, attention, planning) that are impacting their day-to-day activities and quality of life
- Want to learn information and skills to limit the impact of their neurological condition on their emotional and cognitive wellbeing.
-Aged 18 years or older.
-Living in Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Inability to use a computer.
- Very severe depression (i.e., indicated by a score > 22 on the PHQ-9).
- Significant suicidal ideation (i.e., indicated by a score > 2 to Question 9 of the PHQ-9).
- Acutely suicidal or recent history of attempted suicide or self-harm (i.e., last 12 months).
- Serious cognitive impairment or dementia (<21 on the Telephone Interview of Cognitive Status; TICS).
-Not being under the medical management of a doctor for their neurological condition.

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)
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. Participants who met inclusion criteria will be allocated to one group (i.e, the Wellbeing Neuro Course)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As open trial, no randomisation sequence required
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
With alpha set at .05, power set at .80 and a sample size of 100, the study is well powered to enable the detection of moderate-to-large effect size (i.e., Cohen’s d > 0.50) differences in clinical measures from pre-treatment to post-treatment and follow-up.
Subgroup analyses be utilised to assess change in the clinical outcomes from pre-treatment to post-treatment and 3-month follow up for certain, of interest, subgroups. For example, the efficacy and acceptability of the course will be assessed for neurological condition type sub-groups (e.g., epilepsy, MS, TBI, stroke, Parkinson's Disease). Sub-group analyses will also assess treatment effects for participants with baseline levels of anxiety, depression and disability within the clinical ranges separately from the overall sample. Clinical levels of baseline symptoms will be based on the published literature e.g., depression (PHQ-9>9), anxiety (GAD-7 >9) and disability levels (WHODAS 2.0 within the 25th, 50th and 75th percentiles). All analyses will be carried out using conservative intention-to-treat principles and using generalised equation (GEE) models to handle missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/05/2017
Actual
4/07/2017
Date of last participant enrolment
Anticipated
Actual
10/09/2018
Date of last data collection
Anticipated
Actual
12/03/2019
Sample size
Target
100
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 295357 0
University
Name [1] 295357 0
Macquarie University
Country [1] 295357 0
Australia
Funding source category [2] 295358 0
Commercial sector/Industry
Name [2] 295358 0
icare lifetime care
Country [2] 295358 0
Australia
Primary sponsor type
Individual
Name
Dr Milena Gandy
Address
eCentreClinic
Building C3A, Balaclava Road,
Macquarie University
Sydney
NSW 2109
Country
Australia
Secondary sponsor category [1] 294183 0
University
Name [1] 294183 0
Macquarie University
Address [1] 294183 0
Balaclava Road, North Ryde
NSW, 2109, Australia
Country [1] 294183 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296690 0
Macquarie University, HUman Research Ethics Committee
Ethics committee address [1] 296690 0
Human Research Ethics Committee
Level 3, Research Hub, Building C5C, Macquarie University, North Ryde, NSW, 2109.
Ethics committee country [1] 296690 0
Australia
Date submitted for ethics approval [1] 296690 0
08/02/2017
Approval date [1] 296690 0
23/03/2017
Ethics approval number [1] 296690 0
5201700090

Summary
Brief summary
The purpose of the proposed project is to examine the acceptability, efficacy and feasibility of a low-intensity CBT-based self-management program, the Wellbeing Neuro Course to support the emotional and cognitive health of adults with neurological conditions. The proposed trial employs a single-group open-trial design (n = 100) and participants will be given access to a modified version of an established self-management Course for managing depression, anxiety and disability associated with chronic conditions (the Chronic Conditions Course). The Course contains a 6-lesson 10-week internet delivered program. Participants will have brief weekly contact with a clinical psychologist as they work through the Course. A single-group open-trial feasibility design will be employed; all participants are provided full and immediate access to the Wellbeing Neuro Course and are asked to complete standardised questionnaires at 3 main time points: Pre-treatment, post-treatment and 3-month follow-up.
Trial website
www.ecentreclinic.org
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71778 0
Dr Milena Gandy
Address 71778 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 71778 0
Australia
Phone 71778 0
+61298504152
Fax 71778 0
Email 71778 0
milena.gandy@mq.edu.au
Contact person for public queries
Name 71779 0
Milena Gandy
Address 71779 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 71779 0
Australia
Phone 71779 0
+61298504152
Fax 71779 0
Email 71779 0
milena.gandy@mq.edu.au
Contact person for scientific queries
Name 71780 0
Milena Gandy
Address 71780 0
Building C3A, Department of Psychology, Balaclava Road,
Macquarie University, Marsfield, NSW, 2109.
Country 71780 0
Australia
Phone 71780 0
+61298504152
Fax 71780 0
Email 71780 0
milena.gandy@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseA feasibility trial of an internet-delivered psychological intervention to manage mental health and functional outcomes in neurological disorders.2020https://dx.doi.org/10.1016/j.jpsychores.2020.110173
N.B. These documents automatically identified may not have been verified by the study sponsor.