Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial
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 comparati...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2024-04-01
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| Series: | Epilepsia Open |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/epi4.12913 |
| _version_ | 1797231499716591616 |
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| author | Milena Gandy Honor Coleman Henry Cutler Michael P. Jones Eyal Karin Patrick Kwan Armin Nikpour Kaitlyn Parratt Genevieve Rayner Nickolai Titov Lisa Todd Elizabeth Seil Toby Winton‐Brown Wendy Wu Blake F. Dear |
| author_facet | Milena Gandy Honor Coleman Henry Cutler Michael P. Jones Eyal Karin Patrick Kwan Armin Nikpour Kaitlyn Parratt Genevieve Rayner Nickolai Titov Lisa Todd Elizabeth Seil Toby Winton‐Brown Wendy Wu Blake F. Dear |
| author_sort | Milena Gandy |
| collection | DOAJ |
| description | 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. Plain Language Summary This study seeks to find out if a 10‐week online psychological treatment can improve the mental health and well‐being of Australian adults with epilepsy. Around 375 participants will be randomly assigned to different groups: one will receive treatment with guidance from mental health clinician (guided group), one without guidance (unguided group), and one starting later (waiting control group). All participants will fill out the same outcome measures online. The main goal of this research is to compare these groups and assess how well the treatment works in improving mental health outcomes. |
| first_indexed | 2024-04-24T15:45:21Z |
| format | Article |
| id | doaj.art-d3670cc4f74046f6a465ca58701efca4 |
| institution | Directory Open Access Journal |
| issn | 2470-9239 |
| language | English |
| last_indexed | 2024-04-24T15:45:21Z |
| publishDate | 2024-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Epilepsia Open |
| spelling | doaj.art-d3670cc4f74046f6a465ca58701efca42024-04-01T15:36:57ZengWileyEpilepsia Open2470-92392024-04-019280881810.1002/epi4.12913Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trialMilena Gandy0Honor Coleman1Henry Cutler2Michael P. Jones3Eyal Karin4Patrick Kwan5Armin Nikpour6Kaitlyn Parratt7Genevieve Rayner8Nickolai Titov9Lisa Todd10Elizabeth Seil11Toby Winton‐Brown12Wendy Wu13Blake F. Dear14School of Psychological Sciences Macquarie University Sydney New South Wales AustraliaMelbourne School of Psychological Sciences The University of Melbourne Melbourne Victoria AustraliaAustralian Institute of Health Innovation Macquarie University Sydney New South Wales AustraliaSchool of Psychological Sciences Macquarie University Sydney New South Wales AustraliaSchool of Psychological Sciences Macquarie University Sydney New South Wales AustraliaDepartment of Neuroscience, Central Clinical School Monash University Melbourne Victoria AustraliaDepartment of Neurology Royal Prince Alfred Hospital Camperdown New South Wales AustraliaDepartment of Neurology Royal Prince Alfred Hospital Camperdown New South Wales AustraliaMelbourne School of Psychological Sciences The University of Melbourne Melbourne Victoria AustraliaSchool of Psychological Sciences Macquarie University Sydney New South Wales AustraliaEpilepsy Action Australia Sydney New South Wales AustraliaAustralian Institute of Health Innovation Macquarie University Sydney New South Wales AustraliaComprehensive Epilepsy Program Alfred Hospital Melbourne Victoria AustraliaSchool of Psychological Sciences Macquarie University Sydney New South Wales AustraliaSchool of Psychological Sciences Macquarie University Sydney New South Wales AustraliaAbstract 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. Plain Language Summary This study seeks to find out if a 10‐week online psychological treatment can improve the mental health and well‐being of Australian adults with epilepsy. Around 375 participants will be randomly assigned to different groups: one will receive treatment with guidance from mental health clinician (guided group), one without guidance (unguided group), and one starting later (waiting control group). All participants will fill out the same outcome measures online. The main goal of this research is to compare these groups and assess how well the treatment works in improving mental health outcomes.https://doi.org/10.1002/epi4.12913anxietycognitive behavior therapydepressionmoodonline |
| spellingShingle | Milena Gandy Honor Coleman Henry Cutler Michael P. Jones Eyal Karin Patrick Kwan Armin Nikpour Kaitlyn Parratt Genevieve Rayner Nickolai Titov Lisa Todd Elizabeth Seil Toby Winton‐Brown Wendy Wu Blake F. Dear Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial Epilepsia Open anxiety cognitive behavior therapy depression mood online |
| title | Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial |
| title_full | Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial |
| title_fullStr | Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial |
| title_full_unstemmed | Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial |
| title_short | Comparative effectiveness of digital mental healthcare models for adults with epilepsy: A study protocol of a randomized controlled trial |
| title_sort | comparative effectiveness of digital mental healthcare models for adults with epilepsy a study protocol of a randomized controlled trial |
| topic | anxiety cognitive behavior therapy depression mood online |
| url | https://doi.org/10.1002/epi4.12913 |
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