Clinical trial NCT06865820: Implementation and Cost Evaluation of Project UPLIFT
Official title: Implementation and Cost Evaluation of Project UPLIFT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2025-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study tests Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT) which is a Mindfulness-based Cognitive Behavioral Therapy program teaching participants with epilepsy methods that include challenging thoughts, behavioral activation, coping, problem-solving, and mindfulness, for well-being and costs. Project UPLIFT is delivered as weekly sessions over 8 weeks.

Detailed description: Over 3.4 million people in the US have epilepsy, which is a chronic neurological condition that affects individuals across their lifespan. A key feature of epilepsy is the unpredictable occurrence of seizures that can have catastrophic physical and psychological consequences. Even when seizures are well-controlled with anti-seizure medications (ASMs), challenges often persist leading to increased morbidity, mortality, and a decreased quality of life (QOL). Individuals with epilepsy often deal with a complex set of medical and psychosocial issues including stigma and social isolation resulting from misconceptions about epilepsy, lack of understanding around the abilities of people with epilepsy, and a fear of seizures in general. Comorbidities such as cognitive impairment and depression are common in people with epilepsy irrespective of age, gender, and socioeconomic status and are often more disabling than the seizures. Risk factors for poor outcomes in epilepsy include ASM non-adherence and poor social supports, and racial and ethnic minorities and individuals of lower socioeconomic status are particularly likely to have epilepsy complications and poor QOL.

Epilepsy also imposes a substantial economic burden on the individuals impacted, their families, and society. Costs associated with epilepsy illustrate the complexity and financial burden of the disease on the individual and system. A recent study, estimating the prevalence of and characterized health care spending for persons classified with seizure or epilepsy using 2010-2018 Medical Expenditure Panel Survey (MEPS) data across the United States determined direct health care spending for the 3.4 million community dwelling individuals with epilepsy and seizures was approximately $24.5 billion annually over the period 2010-2018; and spending for epilepsy and/or seizures is rising at approximately twice the rate as overall health care spending.

For over 17 years, the Managing Epilepsy Well (MEW) Network has provided evidence and research addressing comorbidities and other epilepsy related challenges. It was created in 2007 with support from the Centers of Disease Control and Prevention (CDC) and the CDC Epilepsy Program. One of the epilepsy self-management programs that has been developed, tested, and deemed evidence-based is Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT). Project UPLIFT focuses on depressive symptoms.

For persons with epilepsy (PWE), self-management specifically includes medication adherence, learning more about their seizures and diagnosis, keeping a seizure diary, or tracking seizures, understanding and avoiding seizure triggers, and reducing stressors that may induce a seizure. The Institute of Medicine's critical goal of epilepsy education identifies three categories of epilepsy self-management, including medication management, behavior changes to help manage epilepsy, and emotional support for dealing with a chronic condition. Epilepsy self-management programs are low-cost, manualized, and designed to overcome transportation barriers-and yet they are not utilized at their fullest potential due to barriers such as limited resources for program adoption, bias in the medical community, and information deficits about efficacy, program delivery, and costs.

Project UPLIFT is a group-based program designed to help increase knowledge and skills, reduce depressive symptoms, and improve quality of life. All study participants will receive the UPLIFT program which is provided as a weekly session over an 8-week period. The study design is a quasi-experimental pretest, posttest evaluation study with a follow-up period of up to 6 months.

Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older
* Diagnosis of epilepsy (self-reported by patient)
* Can speak English
* Has access to a phone or computer

Exclusion Criteria:

* Inability to cognitively participate

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-8) Score
timeFrame: Baseline, Month 3, Month 6
measure: Quality of Life in Epilepsy (QOLIE-10) Score
timeFrame: Baseline, Month 3, Month 6
measure: Quality of Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Preference (PROPr) Score
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
measure: Global Assessment of Severity of Epilepsy (GASE) Scale Score
timeFrame: Baseline, Month 3, Month 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Rollins School of Public Health
state: Georgia
Study officials:
affiliation: Emory University
name: Cam Escoffery, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Katie Bullinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Robin McGee, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: David H Howard, PhD
role: PRINCIPAL_INVESTIGATOR
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