Telephone-Based Support Programs for People With Epilepsy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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;

Первичные конечные точки

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

Вторичные конечные точки (5)

• Change in depressive symptom severity [Срок оценки: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
• Change in seizure frequency [Срок оценки: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
• Change in seizure severity [Срок оценки: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
• Change in disease-specific quality of life [Срок оценки: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]
• Change in general health-related quality of life [Срок оценки: Baseline Visit, 3 month visit, 6 month visit, 12 month visit]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT05082181 · 21-00446

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗