120 Participants Needed

Telephone-Based Support Programs for Epilepsy

LD
TS
Overseen ByTanya Spruill, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment BOOST, UPLIFT, Project UPLIFT, Using Practice and Learning to Increase Favorable Thoughts for epilepsy?

Research shows that telephone-based follow-up programs, like those used in cancer care and emergency medicine, can improve patient outcomes by providing education and addressing concerns. This suggests that similar telephone-based support programs for epilepsy could also be effective in improving patient care.12345

Is telephone-based support for epilepsy safe for humans?

The research articles provided do not contain specific safety data for telephone-based support programs like BOOST, UPLIFT, or Project UPLIFT for epilepsy or other conditions.678910

How is the treatment BOOST, UPLIFT different from other treatments for epilepsy?

BOOST, UPLIFT is unique because it is a telephone-based program that combines cognitive-behavioral therapy and mindfulness to help manage depression in people with epilepsy. Unlike traditional treatments that may focus solely on medication, this program offers a non-drug approach to improve mental health and potentially reduce seizure activity by addressing depression.1112131415

What is the purpose of this trial?

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.

Research Team

Daniel Friedman, MD | NYU Langone Health

Daniel Friedman, MD

Principal Investigator

NYU Langone Health

TS

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with epilepsy diagnosed at least a year ago, who speak English or Spanish and are experiencing mild to moderate depression. They must be willing to have their group phone sessions recorded. People with severe depression, suicidal thoughts, significant cognitive issues, or active psychotic disorders cannot participate.

Inclusion Criteria

I have been diagnosed with epilepsy for over a year.
You have a high score on a depression test called PHQ-9.
I am willing to join group calls that will be recorded.

Exclusion Criteria

You have very strong feelings of sadness (score of 20 or higher on a questionnaire).
You have thoughts about hurting yourself or ending your life.
I do not have an active psychotic disorder.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either UPLIFT or BOOST intervention, which are telephone-based support programs for people with epilepsy, delivered in one-hour weekly sessions over 8 weeks

8 weeks
8 visits (telephone-based)

Follow-up

Participants are monitored for changes in depressive symptoms, quality of life, and seizures over 12 months

12 months
4 visits (in-person or virtual) at 3, 6, and 12 months

Treatment Details

Interventions

  • BOOST
  • UPLIFT
Trial Overview The study compares two telephone-based programs: UPLIFT (depression self-management) and BOOST (support groups), each lasting 8 weeks with one-hour weekly sessions. The goal is to see which program better reduces depressive symptoms and improves quality of life and seizure control in people with epilepsy over a year.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)Experimental Treatment1 Intervention
UPLIFT is a telephone-based depression self-management program for people with epilepsy.
Group II: Arm 2: BOOST (Bringing Out Our Strength Together)Active Control1 Intervention
BOOST is a telephone-based support program for people with epilepsy.

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

Findings from Research

A clinical improvement workshop helped the Epilepsy Team identify effective strategies to enhance the quality and value of care in the epilepsy monitoring unit, demonstrating a commitment to continuous quality improvement in healthcare.
The workshop facilitated the development and testing of specific improvements that were directly linked to better patient outcomes, showcasing a practical approach to enhancing healthcare delivery.
Implementation of a change process to improve outcomes of patients admitted to epilepsy monitoring unit.Sarkissian, S., Politzer, N., Zahn, C., et al.[2019]
A pharmacy-driven postdischarge follow-up program was implemented, successfully reaching 73% of patients and identifying medication discrepancies in 58% of those contacted, highlighting its effectiveness in addressing medication-related concerns.
The program demonstrated that 89% of patients received their new medications within 72 hours, suggesting that timely follow-up can enhance medication adherence and potentially reduce hospital readmissions.
Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center.Patel, SD., Nguyen, PAA., Bachler, M., et al.[2019]
In a study involving 292 patients discharged from an inpatient psychiatry service, adding outreach case management to standard aftercare did not improve patients' quality of life over a follow-up period of 15 to 52 months.
Despite the intervention group receiving additional support, there were no significant differences in various quality-of-life measures, including emotional well-being and daily living activities, compared to the control group.
Does outreach case management improve patients' quality of life?Curtis, JL., Millman, EJ., Struening, EL., et al.[2007]

References

Implementation of a change process to improve outcomes of patients admitted to epilepsy monitoring unit. [2019]
Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. [2019]
Does outreach case management improve patients' quality of life? [2007]
An individualized intervention to improve asthma management among urban Latino and African-American families. [2022]
Decreasing clinically significant adverse events using feedback to emergency physicians of telephone follow-up outcomes. [2019]
Sepulveda Epilepsy Education: the efficacy of a psychoeducational treatment program in treating medical and psychosocial aspects of epilepsy. [2019]
Educational Intervention Improves Compliance With AAN Guidelines for Return Epilepsy Visits: A Quality Improvement Project. [2018]
Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial. [2019]
Liverpool Adverse Events Profile: Italian validation and predictive value for dropout from antiepileptic treatment in people with epilepsy. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Can categorization of patient background problems be used to determine early termination in a clinical trial? [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
The impact of a depression self-management intervention on seizure activity. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Project UPLIFT: Adoption and implementation experiences of an epilepsy self-management program. [2023]
Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Formative and process evaluations of a cognitive-behavioral therapy and mindfulness intervention for people with epilepsy and depression. [2018]
15.United Statespubmed.ncbi.nlm.nih.gov
A telephone-based self-management program for people with epilepsy. [2009]
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