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NCT05082181NARecruiting

Telephone-Based Support Programs for People With Epilepsy

NYU Langone Health

Start Date

11/9/2021

Completion Date

8/31/2027

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.

Eligibility Criteria

Age Range: 18 years to 99 years

Inclusion Criteria: * adult (≥18 years of age); * diagnosed with epilepsy for at least one year; * fluent in English or Spanish; * elevated depressive symptoms (PHQ-9 score ≥10); * willing to participate in audiotaped group telephone sessions Exclusion Criteria: * severe depressive symptoms (PHQ-9 ≥20); * active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening); * active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR); * significant cognitive impairment (indicated in EHR or evident during screening)

Interventions

BEHAVIORAL

UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

BEHAVIORAL

BOOST (Bringing Out Our Strength Together)

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Conditions

Epilepsy

Locations

NYU Langone Health

New York, New York 10016

United States