TY - JOUR
AU - H. M. Munger Clary
AU - B. M. Snively
AU - C. Cagle
AU - R. Kennerly
AU - J. N. Kimball
AU - H. B. Alexander
AU - G. A. Brenes
AU - J. B. Moore
AU - R. A. Hurley
A1 - 
AB - BACKGROUND: Anxiety and depression in people with epilepsy are common and associated with poor outcomes; yet, they often go untreated due to poor mental health specialist access. Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Evaluating implementation outcomes when translating evidence-based interventions to new clinical settings to inform future scaling and incorporation into real-world practice is important. OBJECTIVE: The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety or depressive symptoms and posttraumatic epilepsy. METHODS: CoCarePTE is a 2-site, randomized, single-blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to receive either neurology-based collaborative care or usual care. Adults receiving neurological care at participating centers with anxiety or depressive symptoms and a history of at least mild traumatic brain injury before epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with video or telephone calls every 2 weeks by a care manager for measurement-based anxiety and depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by antidepressant prescribing recommendations by psychiatrists for neurologists via case conferences and care manager-facilitated team communication. In step 2 of the intervention, individuals with <50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life. As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group compared to control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes, including fidelity, acceptability, feasibility, and appropriateness, are evaluated before implementation and at 3 months. The primary effectiveness analysis will compare changes in emotional quality of life scores from baseline to 6 months between the intervention and control arms using multiple linear regression modeling, adjusting for study site and using an intent-to-treat approach. RESULTS: Enrollment commenced in 2023, with modifications in the inclusion and exclusion made after the first 6 enrollees due to slow recruitment. Enrollment is expected to continue at least into early 2025. CONCLUSIONS: The CoCarePTE trial is novel in its use of a hybrid effectiveness-implementation design to evaluate an evidence-based mental health intervention in epilepsy, and by incorporating seizure care into a collaborative care model. If a significant improvement in emotional quality of life is found in the intervention group compared to usual care, this would support next step scaling or clinical implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05353452; https://www.clinicaltrials.gov/study/NCT05353452. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59329.
AD - Department of Neurology, Wake Forest University School of Medicine, Winston-Salem, NC, United States.; Research and Academic Affairs, W. G. Heffner Veterans Affairs Medical Center, Salisbury, NC, United States.; Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston-Salem, NC, United States.; Mental Health and Behavioral Sciences, W. G. Heffner Veterans Affairs Medical Center, Salisbury, NC, United States.; Department of Psychiatry, Wake Forest University School of Medicine, Winston-Salem, NC, United States.; Department of Internal Medicine, Section of Gerontology and Geriatric Medicine, Wake Forest University School of Medicine, Winston-Salem, NC, United States.; Department of Implementation Science, Wake Forest University School of Medicine, Winston-Salem, NC, United States.; Department of Radiology, Wake Forest University School of Medicine, Winston-Salem, NC, United States.
AN - 39535875
BT - JMIR Res Protoc
C5 - Healthcare Disparities; Education & Workforce
DA - Nov 13
DO - 10.2196/59329
DP - NLM
ET - 20241113
JF - JMIR Res Protoc
LA - eng
N2 - BACKGROUND: Anxiety and depression in people with epilepsy are common and associated with poor outcomes; yet, they often go untreated due to poor mental health specialist access. Collaborative care is an integrated care model with a strong evidence base in primary care and medical settings, but it has not been evaluated in neurology clinics. Evaluating implementation outcomes when translating evidence-based interventions to new clinical settings to inform future scaling and incorporation into real-world practice is important. OBJECTIVE: The Collaborative Care for Posttraumatic Epilepsy (CoCarePTE) trial aims to evaluate the effectiveness (improvement in emotional quality of life) and implementation of a collaborative care intervention for people with anxiety or depressive symptoms and posttraumatic epilepsy. METHODS: CoCarePTE is a 2-site, randomized, single-blind, hybrid type 1 effectiveness-implementation trial that will randomize 60 adults to receive either neurology-based collaborative care or usual care. Adults receiving neurological care at participating centers with anxiety or depressive symptoms and a history of at least mild traumatic brain injury before epilepsy onset will be enrolled. The collaborative care intervention is a 24-week stepped-care model with video or telephone calls every 2 weeks by a care manager for measurement-based anxiety and depression care, seizure care monitoring, and brief therapy intervention delivery. This is supplemented by antidepressant prescribing recommendations by psychiatrists for neurologists via case conferences and care manager-facilitated team communication. In step 2 of the intervention, individuals with <50% symptom reduction by 10 weeks will receive an added 8-session remote cognitive behavioral therapy program. The study is powered to detect a moderate improvement in emotional quality of life. As a hybrid type 1 trial, effectiveness is the primary focus, with the primary outcome being a change in emotional quality of life at 6 months in the intervention group compared to control. Secondary effectiveness outcomes are 6-month changes in depression, anxiety, and overall quality of life. Implementation outcomes, including fidelity, acceptability, feasibility, and appropriateness, are evaluated before implementation and at 3 months. The primary effectiveness analysis will compare changes in emotional quality of life scores from baseline to 6 months between the intervention and control arms using multiple linear regression modeling, adjusting for study site and using an intent-to-treat approach. RESULTS: Enrollment commenced in 2023, with modifications in the inclusion and exclusion made after the first 6 enrollees due to slow recruitment. Enrollment is expected to continue at least into early 2025. CONCLUSIONS: The CoCarePTE trial is novel in its use of a hybrid effectiveness-implementation design to evaluate an evidence-based mental health intervention in epilepsy, and by incorporating seizure care into a collaborative care model. If a significant improvement in emotional quality of life is found in the intervention group compared to usual care, this would support next step scaling or clinical implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05353452; https://www.clinicaltrials.gov/study/NCT05353452. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59329.
PY - 2024
SN - 1929-0748
SP - e59329
ST - Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial
T1 - Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial
T2 - JMIR Res Protoc
TI - Collaborative Care to Improve Quality of Life for Anxiety and Depression in Posttraumatic Epilepsy (CoCarePTE): Protocol for a Randomized Hybrid Effectiveness-Implementation Trial
U1 - Healthcare Disparities; Education & Workforce
U3 - 10.2196/59329
VL - 13
VO - 1929-0748
Y1 - 2024
ER -