Implementation and Cost Evaluation of Project UPLIFT

NCT06865820 | Recruiting

• 2 other identifiers: STUDY00008582CDC-STUDY00008582
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

• Patient Health Questionnaire (PHQ-8) Score

  The effectiveness of Project UPLIFT is assessed by examining depressive symptoms. The Patient Health Questionnaire (PHQ-8) is an 8-item instrument asking how often respondents have been bothered by certain problems over the past two weeks. Responses are given on a 4-point scale where "not at all" = 0 and "nearly every day" = 3. Total scores range from 0 to 24 where higher scores indicate increased symptoms of depression.

  Baseline, Month 3, Month 6

• Quality of Life in Epilepsy (QOLIE-10) Score

  The effectiveness of Project UPLIFT is assessed by examining quality of life. The Quality of Life in Epilepsy (QOLIE-10) instrument has 10 questions about health and daily activities. Responses are given on a range of scales, from 1 (the most positive quality of life) to 4 or 6 (the most negative quality of life). Some items are reverse scored. The final score is the average of scores for the individual items. Lower scores indicate greater quality of life while higher scores indicate greater problems from epilepsy.

  Baseline, Month 3, Month 6

• Quality of Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Preference (PROPr) Score

  The effectiveness of Project UPLIFT is assessed by examining health utility. The PROMIS-Preference (PROPr) focuses on 7 PROMIS domains of: Cognitive Function - Abilities; Depression; Fatigue; Pain Interference; Physical Function; Sleep Disturbance; and Ability to Participate in Social Roles and Activities. The PROPr scoring system has single-attribute scoring functions and a multiplicative multi-attribute scoring function for the 7 PROMIS domains. For the single-attribute scoring functions, 0 = the unhealthiest level of the domain and the healthiest levels on all other domains (disutility of the domain under examination), while 1 = utility of full health. For the multi-attribute scoring function, 0 = the utility of dead, and 1 = the utility of full health.

  Baseline, Month 3, Month 6

Secondary Outcomes (1)

• Global Assessment of Severity of Epilepsy (GASE) Scale Score

  Baseline, Month 3, Month 6

Study Arms (1)

Project UPLIFT

EXPERIMENTAL

Adults with epilepsy participating in a group-based program for 8 weeks. Project UPLIFT is designed to increase knowledge and skills, decrease depressive symptoms and improve quality of life.

Behavioral: Project UPLIFT

Interventions

Project UPLIFT BEHAVIORAL

Project UPLIFT is a Mindfulness-based Cognitive Behavioral Therapy program teaching participants methods that include challenging thoughts, behavioral activation, coping, problem-solving, and mindfulness. The program is group-based and provides weekly sessions, delivered remotely via telephone or video conferencing platform, over an 8-week period.

Project UPLIFT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to cognitively participate

Sponsors & Collaborators

• Emory University: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cam Escoffery, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• Katie Bullinger, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

• Robin McGee, PhD, MPH

  Emory University

  PRINCIPAL INVESTIGATOR

• David H Howard, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cam Escoffery, PhD, MPH

CONTACT

404-727-4701; cescoff@emory.edu

Katie Bullinger, MD, PhD

CONTACT

404-778-3444

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Individual participant data will be made available for sharing immediately following publication(s) of this study.
• Access Criteria: Data will be available for sharing with researchers who provide sound research questions and a sound proposal, in order to achieve aims of the proposal. Data will be available on Emory Dataverse. Researchers interested in sharing this data can contact the study PI at cescoff@emory.edu.

Locations

US (1)