NCT05082181

Telephone-Based Support Programs for People With Epilepsy

NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The objectives of the trial are: 1. To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months. 2. To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months. 3. To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination. 4. To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.

Conditions

• Epilepsy

Interventions

Type	Name	Description
BEHAVIORAL	UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)	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.
BEHAVIORAL	BOOST (Bringing Out Our Strength Together)	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.

Timeline

• Start date: 2021-11-09
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2021-10-18
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States