PACES and UPLIFT for Epilepsy

Not yet recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antipsychotics

Disqualifiers: Severe depression, Suicidal ideation, Psychosis, Cognitive impairment

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

Compensation: Varies

Number of Visits: 4

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two programs, UPLIFT and PACES, might improve quality of life and reduce depression and seizures in people with epilepsy. Participants will receive either one of these programs or enhanced usual care to determine which is most effective over a year. It targets individuals who have had epilepsy for at least a year and experience frequent depression symptoms. As an unphased trial, this study provides a unique opportunity to contribute to understanding and improving care for epilepsy and depression.

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's 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 safe for people with epilepsy. This program helps manage depression through group video calls. Studies have found it reduces depression without causing major side effects. Earlier participants reported positive results with no major health issues.

The PACES program also focuses on self-management. Participants in previous studies demonstrated improved epilepsy management without serious side effects. This evidence suggests that both UPLIFT and PACES are well-tolerated. They aim to improve quality of life and help manage symptoms safely. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the PACES and UPLIFT treatments for epilepsy because they offer unique, non-pharmacological approaches to managing the condition. Unlike standard treatments that often rely on medications to control seizures, these interventions focus on enhancing mental health and coping strategies. PACES (Program for Active Consumer Engagement in Self-Management) empowers patients to take charge of their care with personalized self-management techniques. UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) provides cognitive-behavioral therapy specifically tailored to people with epilepsy, aiming to improve mood and reduce seizure frequency through mental well-being. These innovative approaches are designed to complement existing treatments, potentially improving quality of life for individuals with epilepsy.

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

Studies have shown that Project UPLIFT, a treatment in this trial, effectively prevents and reduces symptoms of major depression in people with epilepsy. It uses group telehealth sessions to help manage epilepsy and improve mental health. Participants have reported a better quality of life and fewer episodes of depression.

Research has indicated that PACES (Program of Active Consumer Engagement in Self-management), another treatment option in this trial, helps people with epilepsy improve their self-care skills. Specifically, participants in PACES demonstrated better lifestyle habits and felt less overall distress compared to those not in the program. These findings suggest that both UPLIFT and PACES, as separate arms in this trial, can effectively support people with epilepsy. ^{1 2 4 6 7}

Who Is on the Research Team?

Tanya Spruill, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for NYU patients with epilepsy who want to improve their quality of life, reduce depressive symptoms, and control seizures. Specific eligibility criteria are not provided.

Inclusion Criteria

Able to understand the informed consent and provide consent

Elevated depressive symptoms - Patient Health Questionnaire-9 (PHQ-9) score ≥10; applies to UPLIFT only

I am 18 years old or older.

Exclusion Criteria

Active suicidal ideation (score of ≥1 on PHQ-9 item #9 or otherwise reported during screening)

Significant cognitive impairment (indicated in the EHR or evident during screening)

I have severe depression symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection including patient-reported outcomes and costs

1-2 weeks

1 visit (in-person)

Treatment

Participants receive UPLIFT or PACES self-management programs or enhanced usual care

12 months

Regular visits as per program schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

3 visits (in-person) at 3-, 6-, and 12-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• PACES
• UPLIFT

Trial Overview The study compares two self-management programs: UPLIFT and PACES, each against enhanced usual care. It's a randomized controlled trial looking at how these programs affect quality of life, depression, and seizure control over a year.

How Is the Trial Designed?

Group I: RCT 2: PACES Experimental Treatment 1 Intervention

Participants in RCT 2 assigned to the PACES arm.

Group II: RCT 1: UPLIFT Experimental Treatment 1 Intervention

Participants in RCT 1 assigned to the UPLIFT arm.

Group III: RCT 1: Enhanced Usual Care Active Control 1 Intervention

Participants in RCT 1 assigned to the enhanced usual care arm.

Group IV: RCT 2: Enhanced Usual Care Active Control 1 Intervention

Participants in RCT 2 assigned to the enhanced usual care arm.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26122460/

PACES in Epilepsy: Results of a Self-Management ... Results: PACES participants (n = 38) improved relative to controls (n = 40) on the ESMS (p < 0.001) and subscales [Information (p < 0.001); Lifestyle (p < 0.002)]; ...

2. aesnet.org aesnet.org/abstractslisting/assessing-epilepsy-self-management-program-implementation-in-clinic-and-community-settings

assessing epilepsy self-management program implementation ... Assessing PACES effectiveness involves participant satisfaction with the program. Methods: All PACES facilitators completed 4 hours of didactic ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32401339/

Program of Active Consumer Engagement in Self- ... Results: PACES participants (n = 49) improved relative to controls (n = 52) on the ESES (P < .022) and overall distress composite (P = .008). At ...

4. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(23)00029-X/abstract

MEW network self-management program characteristics and ... PACES in epilepsy: results of a self-management randomized controlled trial. Epilepsia. 2015; 56:1264-1274. Crossref · Scopus (80) · PubMed.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/epi.13052

PACES in epilepsy: Results of a self‐management ... At 6-month follow up, PACES participants remained improved on the ESMS (p = 0.004) and Information subscale (p = 0.009); and Energy/Fatigue (p = ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505018303044

Correlates of epilepsy self-management in MEW Network ... In general, PWE do worse on information, lifestyle, safety, and social support management than on seizure and medication management [2,3]. There is also growing ...

7. aesnet.org aesnet.org/abstractslisting/adapting-paces-in-epilepsy--needs-assessment-survey-of-spanish-speaking-people-with-epilepsy

Adapting-PACES-in-Epilepsy--Needs-Assessment-Survey-of ... A randomized control trial (RCT) of PACES showed immediate and long-term effects on depression, epilepsy self-management and self-efficacy, and ...