Telephone-Based Support Programs for People With Epilepsy

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT05082181
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) — BEHAVIORAL
    UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. 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. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.
  • BOOST (Bringing Out Our Strength Together) — BEHAVIORAL
    BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.

Study Details

This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

Key Dates

Start date
Nov 9, 2021
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
    UPLIFT is a telephone-based depression self-management program for people with epilepsy.
  • Active Comparator: Arm 2: BOOST (Bringing Out Our Strength Together)
    BOOST is a telephone-based support program for people with epilepsy.

Primary Outcome Measure

Presence of clinically significant depressive symptoms [ Time Frame: Baseline Visit ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Tanya Spruill, PHD
[email protected]
646-501-3429
Tanya Spruill, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
NYU Langone Health· New York, NY

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