Recruiting

UPLIFT vs. PACES

Sponsor:

NYU Langone Health

Code:

NCT07087821

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

UPLIFT

PACES

Enhanced Usual Care

Study Details

Brief summary:

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.

Conditions

Epilepsy

Study ID

NCT07087821

Start date

Sep 16, 2025

Status verified date

May, 2026

Completion date

Sep 29, 2027

Anticipated

Primary completion date

Sep 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: RCT 1: UPLIFT

Participants in RCT 1 assigned to the UPLIFT arm.

active comparator: RCT 1: Enhanced Usual Care

Participants in RCT 1 assigned to the enhanced usual care arm.

experimental: RCT 2: PACES

Participants in RCT 2 assigned to the PACES arm.

active comparator: RCT 2: Enhanced Usual Care

Participants in RCT 2 assigned to the enhanced usual care arm.

Interventions

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.

Primary outcome measure

  • Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5 [ Time Frame: Baseline ]
  • Number of Participants with PHQ-9 Score <5 [ Time Frame: Post-Intervention Month 3 Follow-up (Approximately Month 5) ]
  • Number of Participants with PHQ-9 Score <5 [ Time Frame: Post-Intervention Month 6 Follow-up (Approximately Month 8) ]
  • Number of Participants with PHQ-9 Score <5 [ Time Frame: Post-Intervention Month 12 Follow-up (Approximately Month 14) ]
  • Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score [ Time Frame: Baseline ]
  • Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score [ Time Frame: Post-Intervention Month 3 Follow-up (Approximately Month 5) ]
  • Composite PHQ-9 and QOLIE-31 Score [ Time Frame: Post-Intervention Month 6 Follow-up (Approximately Month 8) ]
  • Composite PHQ-9 and QOLIE-31 Score [ Time Frame: Post-Intervention Month 12 Follow-up (Approximately Month 14) ]
  • 5-level EQ-5D version (EQ-5D-5L) Score [ Time Frame: Baseline ]
  • EQ-5D-5L Score [ Time Frame: Post-Intervention Month 3 Follow-up (Approximately Month 5) ]
  • EQ-5D-5L Score [ Time Frame: Post-Intervention Month 6 Follow-up (Approximately Month 8) ]
  • EQ-5D-5L Score [ Time Frame: Post-Intervention Month 12 Follow-up (Approximately Month 14) ]

Central Contacts and Locations

Central contacts

Tanya Spruill, PhD

646-501-3429Tanya.Spruill@nyulangone.org

Locations

NYU Langone Health - NYU Langone Hospital-Brooklyn

Recruiting

Brooklyn, New York, United States, 11220

NYU Langone Health - NYU Comprehensive Epilepsy Center

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

May 29, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-29.