NYU Epilepsy Self-Management Study

NCT ID: NCT07087821

Last Updated: 2025-07-28

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-18

Study Completion Date

2027-09-29

Brief Summary

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The investigators will conduct two-arm randomized controlled trials (RCTs) comparing effects of UPLIFT vs. enhanced usual care and PACES vs. enhanced usual care, respectively, on quality of life, depressive symptoms and seizures over 12 months in NYU patients with epilepsy.

Detailed Description

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UPLIFT and PACES are two evidence-based epilepsy self-management programs whose adoption and impact are limited by the lack of sustainable funding models.

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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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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RCT 1: UPLIFT

Participants in RCT 1 assigned to the UPLIFT arm.

Group Type EXPERIMENTAL

UPLIFT

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

Participants receive referrals to local epilepsy support groups.

RCT 2: PACES

Participants in RCT 2 assigned to the PACES arm.

Group Type EXPERIMENTAL

PACES

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Enhanced Usual Care

Participants receive referrals to local epilepsy support groups.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults (≥18 years)
* 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

* Severe depressive symptoms (score of ≥20 on PHQ-9)
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

NYU Langone Health - NYU Comprehensive Epilepsy Center

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Tanya Spruill, PhD

Role: CONTACT

646-501-3429

Other Identifiers

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U48DP006844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-00151

Identifier Type: -

Identifier Source: org_study_id

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