Telephone-Based Support Programs for People With Epilepsy
Recruiting · NCT05082181 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
BOOST (Bringing Out Our Strength Together)UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
What this trial is about
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.
Who can take part
Age range
18 Years to 99 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States