Telephone support programs for people with epilepsy
NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
NA · NYU Langone Health · NCT05082181
This study is testing two different phone support programs for people with epilepsy who feel depressed to see which one helps them feel better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05082181 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two telephone-based interventions for individuals with epilepsy who experience elevated depressive symptoms. Participants will be randomly assigned to either the UPLIFT program, which focuses on self-management of depression, or the BOOST program, which emphasizes group support. Both interventions consist of eight weekly one-hour sessions and aim to assess changes in depressive symptoms, quality of life, and seizure frequency over a 12-month period. The study will also explore how mindfulness and participant characteristics influence treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older, diagnosed with epilepsy for at least one year, fluent in English or Spanish, and experiencing elevated depressive symptoms.
Not a fit: Patients with severe depressive symptoms, active suicidal ideation, psychotic disorders, or significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve mental health and quality of life for individuals with epilepsy experiencing depression.
How similar studies have performed: Other studies have shown promise in using telephone-based interventions for mental health support, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Daniel Friedman, MD — NYU Langone Health
- Study coordinator: Tanya Spruill, PhD
- Email: Tanya.Spruill@nyulangone.org
- Phone: 646-501-3429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Depression, Seizures, Quality of life, Mindfulness, Telehealth