NCT06865820 · Emory University
Implementation and Cost Evaluation of Project UPLIFT
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Project UPLIFT
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Atlanta, Georgia
Collaborators
Centers for Disease Control and Prevention
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 6, 2025 · Source of record for eligibility and locations