Telephone-Based Support Programs for People With Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts), BOOST (Bringing Out Our Strength Together).
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
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 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.
Detailed 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.
Interventions
- Behavioral 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 - Behavioral 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;
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Change in depressive symptom severity [Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
- Change in seizure frequency [Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
- Change in seizure severity [Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
- Change in disease-specific quality of life [Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
- Change in general health-related quality of life [Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT05082181 · 21-00446