EpilepsyNCT06865820
Implementation and Cost Evaluation of Project UPLIFT
A study testing Project UPLIFT in people with Epilepsy, run by Emory University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Project UPLIFT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years or older
- Diagnosis of epilepsy (self-reported by patient)
- Can speak English
- Has access to a phone or computer
Who cannot join
- Inability to cognitively participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Katie Bullinger, MD, PhD contact
United States1 site, 1 recruiting
- Recruiting
Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Project UPLIFT
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project UPLIFTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Project UPLIFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Month 3, Month 6
Secondary outcomes (1)
Global Assessment of Severity of Epilepsy (GASE) Scale Score
The effectiveness of Project UPLIFT is assessed by examining seizure severity. Seizure severity is assessed with the Global Assessment of Severity of Epilepsy (GASE) Scale. The GASE is a single-item instrument completed by clinicians to rate the overall severity of the individual's epilepsy. Responses range from 1 = "not at all severe" to 7 = "extremely severe."
Measured: Baseline, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start24 Mar 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Ngoc Cam Escoffery, Emory University
- Investigators
- Cam Escoffery, PhD, MPH, Principal investigator, Emory UniversityKatie Bullinger, MD, PhD, Principal investigator, Emory UniversityRobin McGee, PhD, MPH, Principal investigator, Emory UniversityDavid H Howard, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06865820
- Sponsor's protocol ID
- STUDY00008582
- Other IDs
- CDC-STUDY00008582, 2025P009187
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2025
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data collected before and after the intervention will be made available for sharing with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Cost Evaluation of Project UPLIFT
- ClinicalTrials.gov ID
- NCT06865820
- Acronym / sponsor ID
- STUDY00008582
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project UPLIFT | Experimental | Behavioral: Project UPLIFTAdults 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults 18 years or older
- Diagnosis of epilepsy (self-reported by patient)
- Can speak English
- Has access to a phone or computer
Key exclusion criteria (1 listed)
- Inability to cognitively participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project UPLIFTProject 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. | Behavioural | Project UPLIFT |
Primary outcome
Patient Health Questionnaire (PHQ-8) Score
Time frame: Baseline, Month 3, Month 6
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.
Quality of Life in Epilepsy (QOLIE-10) Score
Time frame: Baseline, Month 3, Month 6
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.
Quality of Patient-Reported Outcomes Measurement Information System (PROMIS): PROMIS-Preference (PROPr) Score
Time frame: Baseline, Month 3, Month 6
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.
1 secondary outcome
Global Assessment of Severity of Epilepsy (GASE) Scale Score
Time frame: Baseline, Month 3, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data collected before and after the intervention will be made available for sharing with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie Bullinger, MD, PhD contact
Cam Escoffery, PhD, MPH principal investigator
Emory University
Katie Bullinger, MD, PhD principal investigator
Emory University
Robin McGee, PhD, MPH principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project UPLIFT in people with Epilepsy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cam Escoffery, PhD, MPH (404-727-4701, cescoff@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-8) Score (time frame: Baseline, Month 3, Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 2 Nov 2026.