EpilepsyNCT05082181
Telephone-Based Support Programs for People With Epilepsy
A study testing UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) and BOOST (Bringing Out Our Strength Together) in people with Epilepsy, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) and BOOST (Bringing Out Our Strength Together)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 31 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult (≥18 years of age);
- diagnosed with epilepsy for at least one year;
- fluent in English or Spanish;
- elevated depressive symptoms (PHQ-9 score ≥10);
- willing to participate in audiotaped group telephone sessions
Who cannot join
- severe depressive symptoms (PHQ-9 ≥20);
- active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening);
- active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR);
- significant cognitive impairment (indicated in EHR or evident during screening)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alexis Bartelloni, MSPH contact
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Tanya Spruill, PHD, 646-501-3429, Tanya.Spruill@nyulangone.org
Tanya Spruill, PhD
About this study
Official title: NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.
Read the detailed description
The objectives of the trial are:
- To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months.
- To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months.
- To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination.
- To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.
- Conditions
- Epilepsy
- Being tested
- UPLIFT (Using Practice and Learning to Increase Favorable Thoughts), BOOST (Bringing Out Our Strength Together)
- Keywords
- Epilepsy, Depression, Seizures, Quality of life, Mindfulness, Telehealth
- Medical subject headings
- Epilepsy, Depression, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)Behavioural
UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. 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. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises.
BOOST (Bringing Out Our Strength Together)Behavioural
BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) | Experimental | UPLIFT is a telephone-based depression self-management program for people with epilepsy. Receives: Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) |
| Arm 2: BOOST (Bringing Out Our Strength Together) | Active comparator | BOOST is a telephone-based support program for people with epilepsy. Receives: Behavioral: BOOST (Bringing Out Our Strength Together) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of clinically significant depressive symptoms
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Measured: Baseline Visit
Presence of clinically significant depressive symptoms
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Measured: 3 month visit
Presence of clinically significant depressive symptoms
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Measured: 6 month visit
Presence of clinically significant depressive symptoms
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Measured: 12 month visit
Secondary outcomes (5)
Change in depressive symptom severity
Continuous PHQ-9 scores will be used to evaluate the magnitude of change in depressive symptoms. The PHQ-9 consists of nine questions that ask respondents how often they've "been bothered by any of the following problems" in the past two weeks. The questions address sleep, energy, appetite, and other possible symptoms of depression. Scores are calculated based on how frequently a person experiences these feelings. Score of 1-4 is considered minimal depression; score of 5-9 is considered mild depression; score of 10-14 is considered moderate depression; score of 15-19 is considered moderately severe depression; score of 20-27 is considered severe depression.
Measured: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in seizure frequency
This will be assessed by self-reported 30-day seizure counts.
Measured: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in seizure severity
This will be assessed by a 12-item version of the Liverpool Seizure Severity Scale. The possible scoring ranges are between 7 and 32 for the percept scale and between 10 and 48 for the ictal/postictal scale. The higher the score the more severe the seizures.
Measured: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in disease-specific quality of life
This will be assessed by the Quality of Life in Epilepsy-10 (QOLIE-10) questionnaire, a 10-item measure of epilepsy-specific aspects of qualify of life. The QOLIE-10-P is a brief survey of health-related quality of life for adults with epilepsy. There are 10 questions about health and daily activities, one question about how much distress you feel about problems and worries related to epilepsy, and a review of what bothers you most.
Measured: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in general health-related quality of life
This will be assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-10) questionnaire, a 10-item measure of global health (physical, mental and social functioning) developed by NIH as an indicator for Healthy People 2020. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.
Measured: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start9 Nov 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Friedman, MD, Principal investigator, NYU Langone HealthTanya Spruill, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082181
- Sponsor's protocol ID
- 21-00446
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NYU Managing Epilepsy Well (MEW) Study: A Randomized Controlled Trial of Telephone-Based Support for People With Epilepsy
- ClinicalTrials.gov ID
- NCT05082181
- Acronym / sponsor ID
- 21-00446
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Depression, Seizures, Quality of life, Mindfulness, Telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Oct 2021 (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 is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.
Detailed description
The objectives of the trial are:
- To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months.
- To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months.
- To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination.
- To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) | Experimental | Behavioral: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)UPLIFT is a telephone-based depression self-management program for people with epilepsy. |
| Arm 2: BOOST (Bringing Out Our Strength Together) | Active comparator | Behavioral: BOOST (Bringing Out Our Strength Together)BOOST is a telephone-based support program for people with epilepsy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult (≥18 years of age);
- diagnosed with epilepsy for at least one year;
- fluent in English or Spanish;
- elevated depressive symptoms (PHQ-9 score ≥10);
- willing to participate in audiotaped group telephone sessions
Key exclusion criteria (4 listed)
- severe depressive symptoms (PHQ-9 ≥20);
- active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening);
- active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR);
- significant cognitive impairment (indicated in 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 |
|---|---|---|
| UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)UPLIFT is an 8-week program that combines cognitive behavioral therapy (CBT) and mindfulness techniques and is delivered to small groups of participants by phone. 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. CBT-related skills include thought monitoring, identifying cognitive distortions, problem identification, goal setting, and identifying supports. Relaxation exercises are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to breath, sights and sounds and other meditations. Audio guides are provided for home practice of mindfulness exercises. | Behavioural | Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) |
| BOOST (Bringing Out Our Strength Together)BOOST is a telephone-based support program delivered in 8 weekly group sessions. Each weekly session is 1 hour long and is comprised of a check-in period, introduction of the week's topic, and group discussion. Weekly BOOST session topics include: (1) personal experience of epilepsy; (2) personal experience of mood problems (depression, anxiety, stress); (3) seizure triggers; (4) concerns related to epilepsy treatment (e.g., medication adherence, side effects); (5) changes in seizures over time; (6) the impact of behavior (e.g., sleep, substance use) on seizures; (7) social relationships and epilepsy; and (8) review of the BOOST experience. | Behavioural | Arm 2: BOOST (Bringing Out Our Strength Together) |
Primary outcome
Presence of clinically significant depressive symptoms
Time frame: Baseline Visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
Time frame: 3 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
Time frame: 6 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
Presence of clinically significant depressive symptoms
Time frame: 12 month visit
The primary outcome is a dichotomous measure of depressive symptoms based on a Patient Health Questionnaire (PHQ-9) score of <5 versus ≥5. The PHQ-9 assesses depressive symptoms in the past two weeks. Total scores range from 0-27 with recommended cutoffs for mild (5-9), moderate (10-14), moderately severe (15-19) and severe (≥20) depressive symptoms. A PHQ-9 score of <5 indicates absence of clinically significant depressive symptoms.
5 secondary outcomes
Change in depressive symptom severity
Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in seizure frequency
Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in seizure severity
Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in disease-specific quality of life
Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
Change in general health-related quality of life
Time frame: Baseline Visit, 3 month visit, 6 month visit, 12 month visit
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial, after deidentification.
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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.
Alexis Bartelloni, MSPH contact
Daniel Friedman, MD principal investigator
NYU Langone Health
Tanya Spruill, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) and BOOST (Bringing Out Our Strength Together) in people with Epilepsy, run by NYU Langone Health 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 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 17 Feb 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 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?
Presence of clinically significant depressive symptoms (time frame: Baseline Visit). The study lists 4 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 17 Feb 2026.