Abstract
Objective: Mental health complaints are prevalent among people with epilepsy, yet there are major barriers that prevent access to psychological care, including high out-of-pocket costs and a lack of accessible specialized services. The purpose of the current study is to examine the comparative efficacy, acceptability, cost-effectiveness, and long-term outcomes of a digital psychological intervention when delivered under two models of care (i.e., guided vs. unguided) in supporting the mental health and functioning of adults with epilepsy.
Method: Approximately 375 participants across Australia will be enrolled. Eligible participants will have a confirmed diagnosis of epilepsy, experience difficulties with their emotional health, be at least 18 years of age, and live in Australia. Participants will be randomized (2:2:1) to receive the Wellbeing Neuro Course, a 10-week internet-delivered program, with (i.e., guided) or without guidance by a mental health clinician (i.e., unguided), or be allocated to a treatment-as-usual waiting-list control group. Participants will complete online questionnaires at pre-, post-treatment, and 3- and 12-month follow-up and consent to have their data linked to their medical records to capture healthcare system resource use and costs.
Analysis: Primary outcome measures will be symptoms of depression and anxiety. A cost-utility analysis will be undertaken using the Australian healthcare system perspective and according to current economic evaluation guidelines. Resource use and costs to the healthcare system during the study period will be captured via data linkage to relevant administrative datasets in Australia.
Significance: The results of this trial will provide important data concerning the relative outcomes of these different models of care and will inform the integration of digital psychological interventions translation into healthcare services.
Ethics and dissemination: The Human Research Ethics Committee of Macquarie University approved the proposed study (Reference No: 520231325151475). The results will be disseminated through peer-reviewed publication(s).
Anzctr trial registration number: ACTRN12623001327673.
Method: Approximately 375 participants across Australia will be enrolled. Eligible participants will have a confirmed diagnosis of epilepsy, experience difficulties with their emotional health, be at least 18 years of age, and live in Australia. Participants will be randomized (2:2:1) to receive the Wellbeing Neuro Course, a 10-week internet-delivered program, with (i.e., guided) or without guidance by a mental health clinician (i.e., unguided), or be allocated to a treatment-as-usual waiting-list control group. Participants will complete online questionnaires at pre-, post-treatment, and 3- and 12-month follow-up and consent to have their data linked to their medical records to capture healthcare system resource use and costs.
Analysis: Primary outcome measures will be symptoms of depression and anxiety. A cost-utility analysis will be undertaken using the Australian healthcare system perspective and according to current economic evaluation guidelines. Resource use and costs to the healthcare system during the study period will be captured via data linkage to relevant administrative datasets in Australia.
Significance: The results of this trial will provide important data concerning the relative outcomes of these different models of care and will inform the integration of digital psychological interventions translation into healthcare services.
Ethics and dissemination: The Human Research Ethics Committee of Macquarie University approved the proposed study (Reference No: 520231325151475). The results will be disseminated through peer-reviewed publication(s).
Anzctr trial registration number: ACTRN12623001327673.
| Original language | English |
|---|---|
| Pages (from-to) | 808-818 |
| Number of pages | 11 |
| Journal | Epilepsia Open |
| Volume | 9 |
| Issue number | 2 |
| Early online date | 12 Feb 2024 |
| DOIs | |
| Publication status | Published - Apr 2024 |
Bibliographical note
Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.Keywords
- anxiety
- cognitive behavior therapy
- depression
- mood
- online