None listed
Conditions
Brief summary
Epilepsy is one of the most common, complex, and disabling neurological conditions worldwide. Mental health conditions are highly prevalent among people with epilepsy (PWE), with approximately 1 in 3 developing lifetime diagnoses of depression and anxiety disorders. However, there are significant barriers to accessing effective psychological treatment for PWE, including high costs, travel and mobility restrictions, cognitive difficulties (e.g. poor memory), and low involvement of mental health professionals in the routine care of PWE. As a digital mental health intervention, the Wellbeing Neuro Course offers an innovative solution to these barriers and aims to improve access to effective psychological care for adults with epilepsy within the Australian healthcare system. The Course uses the principles of cognitive behaviour therapy and compensatory cognitive rehabilitation to target several domains of mental health and cognitive function, and was designed specifically for people with neurological conditions. Digital mental health can be provided in both clinician-guided and unguided models, each with their own potential strengths and weaknesses. Guided models may be more expensive and complex given that trained clinicians must be recruited, yet previous research suggests they may be more efficacious than unguided models. In contrast, unguided models have more public health potential as they involve lower costs and are easier to implement into routine care settings, but may be less efficacious for those with complex presentations who would benefit from clinician support. The primary aim of this research project is to examine the comparative efficacy, cost-effectiveness, acceptability, safety, and long-term outcomes of the Wellbeing Neuro Couse when delivered under two different models of care (clinician-guided vs. unguided) for PWE experiencing emotional difficulties. The secondary aim of this research is to provide critical data of the characteristics of patient’s response to treatment to inform the wider dissemination of the program, including examination of the demographic and clinical predictors and moderators of treatment acceptability and efficacy. Consistent with previous trials, we hypothesise that: 1. Both the guided and unguided groups will result in substantial improvements in primary outcomes of depression and anxiety compared to the treatment-as-usual waitlist control (TAI-WLC) group. 2. There will be non-inferiority in clinical efficacy between the guided and unguided groups across the primary outcomes. 3. Both the unguided group and guided group will be cost-effective compared to TAU-WLC, but the unguided group will be more cost-effective relative to the guided group due to lower intervention costs.
Interventions
The intervention is the Wellbeing Neuro Course, which will be delivered under two models of care:
Arm 1 - Guided Treatment, and
Arm 2 - Unguided Treatment.
The Wellbeing Neuro Course is an internet-delivered psychological intervention developed at the eCentreClinic. Participants will be provided with login details and will access and complete the course online from home. It consists of:
(a) 6 online lessons provided over 10 weeks. The lessons will include information about identifying symptoms
The intervention is the Wellbeing Neuro Course, which will be delivered under two models of care: Arm 1 - Guided Treatment, and Arm 2 - Unguided Treatment. The Wellbeing Neuro Course is an internet-delivered psychological intervention developed at the eCentreClinic. Participants will be provided with login details and will access and complete the course online from home. 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. 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. 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). Adherence (e.g., lesson completion, lesson views) will be monitored via the eCentreClinic software, which is used to provide the Wellbeing Neuro Course. The efficacy of the Wellbeing Neuro Course will be examined when delivered under two models of care, which comprise the two treatment arms of this study: Arm 1: Guided Treatment (n=150). In addition to the online Wellbeing Neuro Course detailed above, participants allocated to this group will have access to support from a mental health clinician. All mental health clinicians will be employed by Macquarie University or one of its entities (e.g., MQ Health), and will be provided with training and supervision from a senior psychologist. Participants in the Guided Treatment Group will be informed that their clinician will be available for around 15 minutes each week and will contact them throughout the course via telephone or secure messaging systems, with more clinician time available when clinically indicated. Clinicians will be available to: (1) answer questions; (2) summarise content; (3) encourage skills practice and reinforce progress; (4) enquire about participants’ use of the skills; and (5) normalise challenges. In addition, clinicians will send detailed assessments and treatment progress reports to participants' primary epilepsy health professional. Arm 2: Unguided Treatment (n=150). Participants allocated to this group will receive the Wellbeing Neuro Course detailed above, but will be informed that they will not receive contact during the course unless they experience technical difficulties or a mental health emergency.
Sponsors
Dr. Milena Gandy
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Confirmed diagnosis of epilepsy. (2) Experiencing difficulties with their emotional health. (3) 18+ years of age. (4) Living in Australia.
Exclusion criteria
(1) Imminently suicidal or unable to keep themselves safe. (2) Are experiencing severe cognitive difficulties with day-to-day memory, attention and ability to learn basic information. (3) Are unable to read and understand English. (4) Do not have access to the internet.
Outcome results
None listed