Clinical trial NCT05082181: Telephone-Based Support Programs for People With Epilepsy
Official title: NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Depression
Seizures
Quality of life
Mindfulness
Telehealth
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

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)

Primary outcomes:
measure: Presence of clinically significant depressive symptoms
timeFrame: Baseline Visit
measure: Presence of clinically significant depressive symptoms
timeFrame: 3 month visit
measure: Presence of clinically significant depressive symptoms
timeFrame: 6 month visit
measure: Presence of clinically significant depressive symptoms
timeFrame: 12 month visit
Secondary outcomes:
measure: Change in depressive symptom severity
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in seizure frequency
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in seizure severity
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in disease-specific quality of life
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in general health-related quality of life
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Other outcomes:
measure: Change in perceived social support
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in mindfulness
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in rumination
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in perceived stress
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in anxiety
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in epilepsy self management
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in self-compassion
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
measure: Change in healthcare utilization
timeFrame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tanya Spruill
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Daniel Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References: