RECRUITING

Telephone-Based Support Programs for People With Epilepsy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy

Quick Facts

Study Start:2021-11-09
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05082181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * adult (≥18 years of age);
  2. * diagnosed with epilepsy for at least one year;
  3. * fluent in English or Spanish;
  4. * elevated depressive symptoms (PHQ-9 score ≥10);
  5. * willing to participate in audiotaped group telephone sessions
  1. * severe depressive symptoms (PHQ-9 ≥20);
  2. * active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening);
  3. * active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR);
  4. * significant cognitive impairment (indicated in EHR or evident during screening)

Contacts and Locations

Study Contact

Tanya Spruill, PhD
CONTACT
646-501-3429
Tanya.Spruill@nyulangone.org
Laura Diaz, MPH
CONTACT
Laura.Diaz@nyulangone.org

Principal Investigator

Tanya Spruill
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Daniel Friedman, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Tanya Spruill, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Daniel Friedman, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-09
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-11-09
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy
  • Depression
  • Seizures
  • Quality of life
  • Mindfulness
  • Telehealth

Additional Relevant MeSH Terms

  • Epilepsy