Telephone-Based Support Programs for Epilepsy

Overseen By Tanya Spruill, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antipsychotics

Disqualifiers: Severe depression, Suicidal ideation, Psychotic disorder, Cognitive impairment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 8 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two telephone-based programs to help people with epilepsy manage depression. UPLIFT focuses on teaching self-management skills, while BOOST offers support group sessions. Both programs aim to improve depressive symptoms, quality of life, and seizure control over a year. The trial seeks English or Spanish speakers who have had epilepsy for at least a year and are experiencing noticeable depression. Participants will join weekly group phone sessions for eight weeks. As an unphased trial, this study provides a unique opportunity to explore innovative support methods for managing depression in epilepsy.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Project UPLIFT is generally safe for people with epilepsy. It employs a type of therapy that reduces depression symptoms and enhances overall happiness. Studies have not reported any serious side effects, indicating that the program is well-tolerated.

In contrast, detailed safety information for BOOST, the other program in this trial, is limited. BOOST functions as a support group, and such programs are typically considered safe because they focus on discussion and shared experiences. Although direct safety data is lacking, the program's nature suggests it is unlikely to cause harm.

Thus, both UPLIFT and BOOST appear to be safe options for those interested in joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telephone-based support programs for epilepsy because they offer a unique and accessible approach to managing the condition, especially for individuals dealing with depression. UPLIFT is distinctive as it focuses on depression self-management through telephone sessions, using cognitive-behavioral techniques to promote positive thinking. BOOST, on the other hand, emphasizes community support and empowerment by connecting individuals with epilepsy through structured phone calls. Unlike traditional treatments, which often involve medication and in-person therapy, these programs provide support remotely, making them more accessible for people who may have mobility or transportation challenges.

What evidence suggests that this trial's treatments could be effective for people with epilepsy?

Research has shown that Project UPLIFT, one of the programs tested in this trial, can help prevent major depression and reduce depression symptoms in people with epilepsy. Participants reported greater life satisfaction after completing the program. BOOST, another program under study, offers less detailed information about its effectiveness but is designed to provide peer support and shared experiences to enhance emotional well-being and quality of life. These programs aim to help people with epilepsy manage depression and improve their overall quality of life through regular, structured sessions. ^{1 2 4 6 7}

Who Is on the Research Team?

Daniel Friedman, MD

Principal Investigator

NYU Langone Health

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) Experimental Treatment 1 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 Control 1 Intervention

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Project UPLIFT, an online intervention based on mindfulness-based cognitive therapy, significantly reduced the number of seizures in adults with epilepsy, with participants experiencing an average decrease of 3.2 seizures compared to an increase of 2.3 in the treatment-as-usual group.

While the intervention did not directly affect seizure severity, it did lead to a reduction in perceived severity through decreased depressive symptoms, indicating that improving mental health can have positive effects on seizure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a depression self-management intervention on seizure activity. Thompson, NJ., McGee, RE., Garcia-Williams, A., et al.[2023]

A telephone-based self-management program for adults with epilepsy was well-accepted, with 95% of planned sessions completed, indicating high feasibility and participant satisfaction.

The program, which utilized motivational interviewing techniques, showed promise for further development and testing, suggesting it could effectively support adults in managing their epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telephone-based self-management program for people with epilepsy. DiIorio, C., Reisinger, EL., Yeager, KA., et al.[2009]

In a study of 622 patients in a long-term antiepileptic drug trial, over half of the participants who dropped out did so due to failure to return to the clinic, highlighting the importance of patient engagement in clinical trials.

Pre-entry health issues, such as medical, medication noncompliance, and psychiatric problems, were significant predictors of early termination, but targeted support for at-risk patients helped some remain in the study, suggesting that early identification and intervention can improve retention rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can categorization of patient background problems be used to determine early termination in a clinical trial? Cramer, JA., Collins, JF., Mattson, RH.[2019]

Project UPLIFT, a program using cognitive-behavioral therapy and mindfulness, was found to be acceptable and beneficial for reducing depressive symptoms in people with epilepsy, based on evaluations from 47 participants.

The program's delivery methods, which include phone and Internet options, were assessed for feasibility, indicating that such remote interventions can effectively support individuals with chronic diseases at risk for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formative and process evaluations of a cognitive-behavioral therapy and mindfulness intervention for people with epilepsy and depression. Walker, ER., Obolensky, N., Dini, S., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does outreach case management improve patients' quality of life? Curtis, JL., Millman, EJ., Struening, EL., et al.[2007]

The culturally adapted UPLIFT program, delivered via telephone in English or Spanish, was found to be feasible and acceptable for Hispanic adults with epilepsy, with high recruitment (76% consent rate) and retention rates (86-93%).

Participants in the UPLIFT program showed significantly lower rates of clinically significant depressive symptoms compared to usual care at 6 months (40% vs. 70%) and 12 months (47% vs. 70%), indicating its effectiveness in reducing depression in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-based depression self-management in Hispanic adults with epilepsy: a pilot randomized controlled trial. Spruill, TM., Friedman, D., Diaz, L., et al.[2021]

The UPLIFT program, an 8-session telehealth intervention for people with epilepsy, has been positively received by community-based providers, with 76% of implementors planning to continue offering it due to its perceived effectiveness in addressing mental health issues.

Key factors for successful implementation included strong organizational support, participant interest, and the presence of program champions, although challenges like recruitment and funding were significant barriers to ongoing delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project UPLIFT: Adoption and implementation experiences of an epilepsy self-management program. McGee, RE., Patel, A., Drzymalla, EM., et al.[2023]

The Sepulveda Epilepsy Education program (SEE) significantly improved participants' understanding of epilepsy, reduced fear of seizures, and decreased risky self-management practices among 38 outpatients over a 2-day treatment period.

Participants in the SEE program also showed improved medication compliance, as evidenced by objective measures of blood levels of antiepileptic drugs, compared to those in the waiting-list control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sepulveda Epilepsy Education: the efficacy of a psychoeducational treatment program in treating medical and psychosocial aspects of epilepsy. Helgeson, DC., Mittan, R., Tan, SY., et al.[2019]

In a study of 174 adult patients with epilepsy and chronic comorbidities, a patient-tailored educational plan significantly improved the number of patients free from adverse treatment effects and drug interactions after 6 months, with 44.0% achieving this compared to 28.9% in the usual care group (p=0.0399).

The educational intervention was particularly effective in reducing drug interactions, highlighting its potential as a safe and cost-effective strategy for managing complex medication regimens in epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive educational plan for patients with epilepsy and comorbidity (EDU-COM): a pragmatic randomised trial. Beretta, S., Beghi, E., Messina, P., et al.[2019]

The Italian version of the Liverpool Adverse Events Profile (iLAEP) was validated as a reliable tool for monitoring adverse events of antiepileptic drugs (AEDs) in 204 patients, showing high internal consistency and a quick completion time of about 9 minutes.

The iLAEP effectively predicts treatment discontinuation, with a cutoff score of 36.5 indicating a significant risk of dropout, as patients scoring above this threshold had a 20.27-fold increased risk of stopping their AED treatment within 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liverpool Adverse Events Profile: Italian validation and predictive value for dropout from antiepileptic treatment in people with epilepsy. Romoli, M., Eusebi, P., Siliquini, S., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. Patel, SD., Nguyen, PAA., Bachler, M., et al.[2019]

An educational intervention for asthma patients, involving family education and improved doctor-patient interactions, led to significant improvements in knowledge, self-efficacy, and adherence to treatment among families in an urban Latino and African-American community over three months.

The intervention resulted in decreased asthma symptoms and activity restrictions, as well as increased prescriptions for anti-inflammatory medications, highlighting its efficacy in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An individualized intervention to improve asthma management among urban Latino and African-American families. Bonner, S., Zimmerman, BJ., Evans, D., et al.[2022]

A quality improvement program that included telephone follow-ups and physician feedback significantly reduced return visits to the emergency department from 10.1% to 4.9% among high-risk patients, indicating improved patient management.

The program also decreased clinically significant adverse events from 4.1% to 1.5%, demonstrating its effectiveness in enhancing patient safety after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing clinically significant adverse events using feedback to emergency physicians of telephone follow-up outcomes. Chern, CH., How, CK., Wang, LM., et al.[2019]

A quality improvement project showed that educating healthcare providers about the American Academy of Neurology's guidelines for follow-up care in epilepsy significantly improved compliance with 4 out of 8 recommended measures.

The intervention, which included educational materials and templates, demonstrated that simple and low-resource strategies can effectively enhance the quality of care for epilepsy patients during return seizure visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educational Intervention Improves Compliance With AAN Guidelines for Return Epilepsy Visits: A Quality Improvement Project. Nelson, GR., Filloux, FM., Kerr, LM.[2018]

Citations

1. withpower.com withpower.com/trial/phase-epilepsy-9-2021-ef857

Telephone-Based Support Programs for Epilepsy This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST).

2. epilepsy.com epilepsy.com/stories/stronger-together-epilepsy-therapy-project-and-epilepsy-foundation-decide-merge-our

Stronger Together: The Epilepsy Therapy Project and ... Epilepsy Therapy Project and Epilepsy Foundation are merging in full — in a manner that respects the priorities and missions of the two organizations ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9169940/

Effectiveness of a Self-Management Program to Improve ... A self-management program to improve cognition and quality of life in epilepsy: a pragmatic, randomized, multicenter trial.

4. researchgate.net researchgate.net/publication/347070367_Getting_Physical_A_Specific_Boost_for_Cognition_in_Epilepsy

Getting Physical: A Specific Boost for Cognition in Epilepsy? Significance This randomized controlled trial provided the first evidence that combined physical training improves executive function in adults ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03484039

Incorporating Multidimensional Psychosocial Interventions ... The purpose of this study is to incorporate multidimensional self-management programs into the routine care of epilepsy patients. Consenting patients will ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03484039?tab=history&a=7

Record History | ver. 7: 2020-03-10 | NCT03484039 An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. chwresourcehub.org chwresourcehub.org/projects/using-practice-and-learning-to-increase-favorable-thoughts-uplift-2-0

Using Practice and Learning to Increase Favorable ... The second arm is BOOST (Bringing Our Strength Together), a group-based support program for people with epilepsy. Download a .zip file of all documents in ...