Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
108 participants
INTERVENTIONAL
2025-07-18
2027-09-29
Brief Summary
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Detailed Description
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The investigators will conduct an economic evaluation of these programs using data from completed and new trials in both healthcare and community settings.
The investigators will conduct two parallel RCTs to compare effects of UPLIFT vs. enhanced usual care, and separately, PACES vs. enhanced usual care.
Outcome data including patient-reported outcomes and costs will be aligned across the two trials and community implementation and collected at baseline and 3-, 6-, and 12-month follow-up visits for use in the economic evaluations.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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RCT 1: UPLIFT
Participants in RCT 1 assigned to the UPLIFT arm.
UPLIFT
UPLIFT is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. UPLIFT is focused on self-management of depressive symptoms.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
RCT 1: Enhanced Usual Care
Participants in RCT 1 assigned to the enhanced usual care arm.
Enhanced Usual Care
Participants receive referrals to local epilepsy support groups.
RCT 2: PACES
Participants in RCT 2 assigned to the PACES arm.
PACES
PACES is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. PACES focuses on general epilepsy self-management.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
RCT 2: Enhanced Usual Care
Participants in RCT 2 assigned to the enhanced usual care arm.
Enhanced Usual Care
Participants receive referrals to local epilepsy support groups.
Interventions
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UPLIFT
UPLIFT is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. UPLIFT is focused on self-management of depressive symptoms.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
PACES
PACES is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. PACES focuses on general epilepsy self-management.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
Enhanced Usual Care
Participants receive referrals to local epilepsy support groups.
Eligibility Criteria
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Inclusion Criteria
* English-speaking (UPLIFT and PACES) or Spanish-speaking (UPLIFT only).
* Diagnosed with epilepsy for at least one year
* Able to understand the informed consent and provide consent
* Elevated depressive symptoms - Patient Health Questionnaire-9 (PHQ-9) score ≥10; applies to UPLIFT only
Exclusion Criteria
* Active suicidal ideation (score of ≥1 on PHQ-9 item #9 or otherwise reported during screening)
* Active psychotic disorder (psychiatric diagnosis and/or antipsychotic medications in the electronic health records (EHR)
* Significant cognitive impairment (indicated in the EHR or evident during screening)
18 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Centers for Disease Control and Prevention
FED
Responsible Party
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Principal Investigators
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Tanya Spruill, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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NYU Langone Health - NYU Langone Hospital-Brooklyn
Brooklyn, New York, United States
NYU Langone Health - NYU Comprehensive Epilepsy Center
New York, New York, United States
Countries
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Central Contacts
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Other Identifiers
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25-00151
Identifier Type: -
Identifier Source: org_study_id
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