EpilepsyNCT07087821
NYU Epilepsy Self-Management Study
A study testing UPLIFT and PACES in people with Epilepsy, run by NYU Langone Health at 2 sites in United States.
Trial summary
The investigators will conduct two-arm randomized controlled trials (RCTs) comparing effects of UPLIFT vs. enhanced usual care and PACES vs. enhanced usual care, respectively, on quality of life, depressive symptoms and seizures over 12 months in NYU patients with epilepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- UPLIFT and PACES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2025to 29 Sep 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)
- English-speaking (UPLIFT and PACES) or Spanish-speaking (UPLIFT only).
- Diagnosed with epilepsy for at least one year
- Able to understand the informed consent and provide consent
- Elevated depressive symptoms - Patient Health Questionnaire-9 (PHQ-9) score ≥10; applies to UPLIFT only
Who cannot join
- Severe depressive symptoms (score of ≥20 on PHQ-9)
- Active suicidal ideation (score of ≥1 on PHQ-9 item #9 or otherwise reported during screening)
- Active psychotic disorder (psychiatric diagnosis and/or antipsychotic medications in the electronic health records (EHR)
- Significant cognitive impairment (indicated in the EHR or evident during screening)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health - NYU Langone Hospital-Brooklyn
Brooklyn, New York, 11220
- Recruiting
NYU Langone Health - NYU Comprehensive Epilepsy Center
New York, New York, 10016
About this study
Official title: Economic Evaluation of Managing Epilepsy Well (MEW) Network Epilepsy Self-Management Programs
The investigators will conduct two-arm randomized controlled trials (RCTs) comparing effects of UPLIFT vs. enhanced usual care and PACES vs. enhanced usual care, respectively, on quality of life, depressive symptoms and seizures over 12 months in NYU patients with epilepsy.
Read the detailed description
UPLIFT and PACES are two evidence-based epilepsy self-management programs whose adoption and impact are limited by the lack of sustainable funding models.
The investigators will conduct an economic evaluation of these programs using data from completed and new trials in both healthcare and community settings.
The investigators will conduct two parallel RCTs to compare effects of UPLIFT vs. enhanced usual care, and separately, PACES vs. enhanced usual care.
Outcome data including patient-reported outcomes and costs will be aligned across the two trials and community implementation and collected at baseline and 3-, 6-, and 12-month follow-up visits for use in the economic evaluations.
- Conditions
- Epilepsy
- Being tested
- UPLIFT, PACES, Enhanced Usual Care
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPLIFTBehavioural
UPLIFT is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. UPLIFT is focused on self-management of depressive symptoms.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
PACESBehavioural
PACES is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. PACES focuses on general epilepsy self-management.
Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment.
Enhanced Usual CareBehavioural
Participants receive referrals to local epilepsy support groups.
| Study group | Role | What they receive |
|---|---|---|
| RCT 1: UPLIFT | Experimental | Participants in RCT 1 assigned to the UPLIFT arm. Receives: Behavioral: UPLIFT |
| RCT 1: Enhanced Usual Care | Active comparator | Participants in RCT 1 assigned to the enhanced usual care arm. Receives: Behavioral: Enhanced Usual Care |
| RCT 2: PACES | Experimental | Participants in RCT 2 assigned to the PACES arm. Receives: Behavioral: PACES |
| RCT 2: Enhanced Usual Care | Active comparator | Participants in RCT 2 assigned to the enhanced usual care arm. Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5
RCT 1 participants only.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Measured: Baseline
Number of Participants with PHQ-9 Score <5
RCT 1 participants only.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Measured: Post-Intervention Month 3 Follow-up (Approximately Month 5)
Number of Participants with PHQ-9 Score <5
RCT 1 participants only.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Measured: Post-Intervention Month 6 Follow-up (Approximately Month 8)
Number of Participants with PHQ-9 Score <5
RCT 1 participants only.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Measured: Post-Intervention Month 12 Follow-up (Approximately Month 14)
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
RCT 2 participants only.
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Measured: Baseline
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
RCT 2 participants only.
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Measured: Post-Intervention Month 3 Follow-up (Approximately Month 5)
Composite PHQ-9 and QOLIE-31 Score
RCT 2 participants only.
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Measured: Post-Intervention Month 6 Follow-up (Approximately Month 8)
Composite PHQ-9 and QOLIE-31 Score
RCT 2 participants only.
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Measured: Post-Intervention Month 12 Follow-up (Approximately Month 14)
5-level EQ-5D version (EQ-5D-5L) Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Measured: Baseline
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Measured: Post-Intervention Month 3 Follow-up (Approximately Month 5)
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Measured: Post-Intervention Month 6 Follow-up (Approximately Month 8)
EQ-5D-5L Score
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
Measured: Post-Intervention Month 12 Follow-up (Approximately Month 14)
Secondary outcomes (13)
Change from Baseline in PHQ-9 Score
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
Measured: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in PHQ-9 Score
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
Measured: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in PHQ-9 Score
The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression.
Measured: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in QOLIE-31
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
Measured: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in QOLIE-31
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
Measured: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in QOLIE-31
The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL.
Measured: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in Seizure Frequency
Measured: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in Seizure Frequency
Measured: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in Seizure Frequency
Measured: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Measured: Baseline
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Measured: Post-Intervention Month 3 Follow-up (Approximately Month 5)
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Measured: Post-Intervention Month 6 Follow-up (Approximately Month 8)
Healthcare Utilization
A composite count of outpatient visits, hospitalizations, and emergency department visits will be collected using a combination of EHR review and patient self-report.
Measured: Post-Intervention Month 12 Follow-up (Approximately Month 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start16 Sep 2025
- Primary completion29 Sep 2027 (estimated)
- Study completion29 Sep 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 NYU Langone HealthThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Tanya Spruill, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087821
- Sponsor's protocol ID
- 25-00151
- Other IDs
- U48DP006844
- Status last verified
- May 2026
- First submitted
- 17 Jul 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Tanya.Spruill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Managing Epilepsy Well (MEW) Network Epilepsy Self-Management Programs
- ClinicalTrials.gov ID
- NCT07087821
- Acronym / sponsor ID
- 25-00151
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 29 Sep 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 28 Jul 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.
The investigators will conduct two-arm randomized controlled trials (RCTs) comparing effects of UPLIFT vs. enhanced usual care and PACES vs. enhanced usual care, respectively, on quality of life, depressive symptoms and seizures over 12 months in NYU patients with epilepsy.
Detailed description
UPLIFT and PACES are two evidence-based epilepsy self-management programs whose adoption and impact are limited by the lack of sustainable funding models.
The investigators will conduct an economic evaluation of these programs using data from completed and new trials in both healthcare and community settings.
The investigators will conduct two parallel RCTs to compare effects of UPLIFT vs. enhanced usual care, and separately, PACES vs. enhanced usual care.
Outcome data including patient-reported outcomes and costs will be aligned across the two trials and community implementation and collected at baseline and 3-, 6-, and 12-month follow-up visits for use in the economic evaluations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RCT 1: UPLIFT | Experimental | Behavioral: UPLIFTParticipants in RCT 1 assigned to the UPLIFT arm. |
| RCT 1: Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants in RCT 1 assigned to the enhanced usual care arm. |
| RCT 2: PACES | Experimental | Behavioral: PACESParticipants in RCT 2 assigned to the PACES arm. |
| RCT 2: Enhanced Usual Care | Active comparator | Behavioral: Enhanced Usual CareParticipants in RCT 2 assigned to the enhanced usual care arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (≥18 years)
- English-speaking (UPLIFT and PACES) or Spanish-speaking (UPLIFT only).
- Diagnosed with epilepsy for at least one year
- Able to understand the informed consent and provide consent
- Elevated depressive symptoms - Patient Health Questionnaire-9 (PHQ-9) score ≥10; applies to UPLIFT only
Key exclusion criteria (4 listed)
- Severe depressive symptoms (score of ≥20 on PHQ-9)
- Active suicidal ideation (score of ≥1 on PHQ-9 item #9 or otherwise reported during screening)
- Active psychotic disorder (psychiatric diagnosis and/or antipsychotic medications in the electronic health records (EHR)
- Significant cognitive impairment (indicated in the EHR or evident during screening)
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 |
|---|---|---|
| UPLIFTUPLIFT is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. UPLIFT is focused on self-management of depressive symptoms. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment. | Behavioural | RCT 1: UPLIFT |
| PACESPACES is an 8-week epilepsy self-management programs delivered to small groups of people with epilepsy (PWE) by Webex. PACES focuses on general epilepsy self-management. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise and a home practice assignment. | Behavioural | RCT 2: PACES |
| Enhanced Usual CareParticipants receive referrals to local epilepsy support groups. | Behavioural | RCT 1: Enhanced Usual Care, RCT 2: Enhanced Usual Care |
Primary outcome
Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5
Time frame: Baseline
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Number of Participants with PHQ-9 Score <5
Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Number of Participants with PHQ-9 Score <5
Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Number of Participants with PHQ-9 Score <5
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)
RCT 1 participants only. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The primary outcome is the count of participants who score less than 5 on the PHQ-9 (i.e., absence of clinically significant depressive symptoms).
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
Time frame: Baseline
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Composite PHQ-9 and Quality of Life in Epilepsy Inventory-31 (QOLIE-31) Score
Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Composite PHQ-9 and QOLIE-31 Score
Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
Composite PHQ-9 and QOLIE-31 Score
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)
RCT 2 participants only. The QOLIE-31 is a 31-item questionnaire evaluating an epilepsy patient's quality of life (QOL) perception. The overall score is derived by weighing and then summing the 7 domain scores, which correspond with the item responses. The overall score is converted to a final, 0-100 point score, where higher converted scores reflect better QOL. The PHQ-9 is a 9-item assessment of depression; each item is rated on a scale from 0-3. The total score is the sum of item responses and ranges from 0-27; higher scores indicate greater levels of depression. The scores from both the PHQ-9 and QOLIE-3 are re-scaled into a combined, Composite PHQ+QOLIE Score ranging from 0-100; higher values indicate more favorable outcomes.
5-level EQ-5D version (EQ-5D-5L) Score
Time frame: Baseline
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
EQ-5D-5L Score
Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
EQ-5D-5L Score
Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
EQ-5D-5L Score
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)
The EQ-5D-5L is a standardized questionnaire used to measure health-related quality of life (HRQoL). It consists of two parts: a descriptive system and a visual analogue scale (EQ VAS). The descriptive system assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each with five levels of severity. The EQ VAS provides a self-assessment of overall health on a scale of 0 to 100, where higher scores indicate better health. The EQ-5D-5L will be used to derive utility values to estimate quality-adjusted life years (QALYs) for cost-utility analyses.
13 secondary outcomes
Change from Baseline in PHQ-9 Score
Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in PHQ-9 Score
Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in PHQ-9 Score
Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in QOLIE-31
Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in QOLIE-31
Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in QOLIE-31
Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Change from Baseline in Seizure Frequency
Time frame: Baseline, Post-Intervention Month 3 Follow-up (Approximately Month 5)
Change from Baseline in Seizure Frequency
Time frame: Baseline, Post-Intervention Month 6 Follow-up (Approximately Month 8)
Change from Baseline in Seizure Frequency
Time frame: Baseline, Post-Intervention Month 12 Follow-up (Approximately Month 14)
Healthcare Utilization
Time frame: Baseline
Healthcare Utilization
Time frame: Post-Intervention Month 3 Follow-up (Approximately Month 5)
Healthcare Utilization
Time frame: Post-Intervention Month 6 Follow-up (Approximately Month 8)
Healthcare Utilization
Time frame: Post-Intervention Month 12 Follow-up (Approximately Month 14)
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 29 May 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Tanya.Spruill@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Tanya Spruill, PhD principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPLIFT and PACES in people with Epilepsy, run by NYU Langone Health at 2 sites 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 5 inclusion and 4 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tanya Spruill, PhD (646-501-3429, Tanya.Spruill@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Patient Health Questionnaire-9 (PHQ-9) Score <5 (time frame: Baseline). The study lists 12 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 29 May 2026.