Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT05082181

Conditions

Epilepsy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

BOOST (Bringing Out Our Strength Together)

Study Details

Brief 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.

Conditions

Epilepsy

Study ID

NCT05082181

Start date

Nov 9, 2021

Status verified date

Feb, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

UPLIFT is a telephone-based depression self-management program for people with epilepsy.

active comparator: Arm 2: BOOST (Bringing Out Our Strength Together)

BOOST is a telephone-based support program for people with epilepsy.

Interventions

UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)

UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home practice assignment. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.

BOOST (Bringing Out Our Strength Together)

BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.

Primary outcome measure

  • Presence of clinically significant depressive symptoms [ Time Frame: Baseline Visit ]
  • Presence of clinically significant depressive symptoms [ Time Frame: 3 month visit ]
  • Presence of clinically significant depressive symptoms [ Time Frame: 6 month visit ]
  • Presence of clinically significant depressive symptoms [ Time Frame: 12 month visit ]

Central Contacts and Locations

Central contacts

Tanya Spruill, PhD

646-501-3429Tanya.Spruill@nyulangone.org

Alexis Bartelloni, MSPH

Alexis.Bartelloni@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Tanya Spruill, PHD

646-501-3429Tanya.Spruill@nyulangone.org

Principal Investigator:

Tanya Spruill, PhD

More Information

Sponsor

NYU Langone Health

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-02-17.