NYU Epilepsy Self-Management Study

NYU Langone Health

Status: Not yet enrolling

Conditions: Epilepsy

Treatments: Behavioral: UPLIFT; Behavioral: PACES; Behavioral: Enhanced Usual Care

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07087821

25-00151

U48DP006844 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 4 patient groups

RCT 1: UPLIFT

Experimental group

Description:

Participants in RCT 1 assigned to the UPLIFT arm.

Treatment:

Behavioral: UPLIFT

RCT 1: Enhanced Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care

RCT 2: PACES

Experimental group

Description:

Participants in RCT 2 assigned to the PACES arm.

Treatment:

Behavioral: PACES

RCT 2: Enhanced Usual Care

Active Comparator group

Description:

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

Treatment:

Behavioral: Enhanced Usual Care