RecruitingNot ApplicableNCT05082181

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

Sponsor

NYU Langone Health

Enrollment

120 participants

Start Date

Nov 9, 2021

Study Type

INTERVENTIONAL

Conditions

Epilepsy

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing telephone-based group support programs to help people with epilepsy who are also experiencing depressive symptoms, using both education-focused and therapy-focused approaches. **You may be eligible if...** - You are 18 or older with a diagnosis of epilepsy for at least one year - You are fluent in English or Spanish - You have moderate depressive symptoms (PHQ-9 score of 10–19) - You are willing to participate in recorded group telephone sessions **You may NOT be eligible if...** - You have severe depression (PHQ-9 score 20 or higher) - You have active suicidal thoughts - You have an active psychotic disorder or are taking antipsychotic medications - You have significant cognitive impairment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALUPLIFT (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.

BEHAVIORALBOOST (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.