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Telephone-Based Support Programs for People With Epilepsy

Telephone-Based Support Programs for People With Epilepsy

Recruiting
18-99 years
All
Phase N/A

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Overview

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 Englishand 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.

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

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)

Study details
    Epilepsy

NCT05082181

NYU Langone Health

9 June 2024

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