LifestyleLIFENCT05283200
Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
A study testing Yoga, Cognitive Behavioral Therapy and Music in people with Lifestyle, run by Imad Najm MD at 1 site in United States.
Trial summary
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lifestyle
- What is being tested?
- Yoga, Cognitive Behavioral Therapy and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2022to Jun 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (ages 18-75) patients of the Cleveland Clinic Epilepsy Center with a confirmed diagnosis of epilepsy
- Ability to independently provide informed consent
- At the time of enrollment, patients must have had at least 1 seizure within the past 30 days
- No anticipated anti-seizure medication adjustments
- Internet access and the ability to participate in online video streaming
- Reading abilities at or above 8th grade level as determined by the Wide Range Achievement Test- 4th Edition (WRAT-4) Reading subtest
- Willing and able to participate in any of the assigned interventions which may include yoga or music therapy
Who cannot join
- Patients with a history of non-epileptic or psychogenic seizures
- Any patient that has engaged in yoga or music therapy within the last 6 months
- Currently enrolled in another interventional study for epilepsy at the time of enrollment.
- Anticipated or scheduled epilepsy surgery within 6 months
- Pending litigation related to the cause of epilepsy or current application for long term disability
- Participants with a diagnosed, symptomatic, chronic illness (i.e., significant psychiatric concerns, liver, gastrointestinal, respiratory, renal, cardiac, etc.) who, based on primary investigator review, will not be able to participate in the study safely or effectively.
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- Undergoing intensive medical treatment for serious or life-threatening illness (e.g., chemotherapy, etc.) that would impact study participation.
- Currently pregnant or less than 6 weeks postpartum
- Significant hearing loss
- Blindness
- Musicogenic epilepsy or seizures
Trial locations and contacts
1 site in 1 country.
About this study
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.
Read the detailed description
In this prospective controlled, randomized study, investigators aim to assess the impact of integrative behavioral and wellness-based interventions on seizure frequency (primary outcome measure), stress, cognitive function, and quality of life (secondary outcome measures) in patients with difficult to treat epilepsy. The study team will accomplish these objectives through three active interventions that include: cognitive behavioral therapy (CBT), yoga therapy, and music therapy. This study will have two control groups who will continue with their standard of care as guided by their epilepsy provider. Investigators will measure the effects of our interventions using seizure diaries, cognitive assessments, and health and quality of life questionnaires. In this study, the study team will collect, process, store, and analyze human biospecimens of enrolled participants for research purposes to assess the potential biologic impact of our interventions. Collection, processing, storage, and data management of the biospecimens to be used for this study, and future studies, will be completed through Lerner Research Institute.
The CBT arm is currently closed to enrollment as of 8/14/2023.
- Conditions
- Lifestyle
- Being tested
- Yoga, Cognitive Behavioral Therapy, Music
- Keywords
- Epilepsy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Yoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction
Cognitive Behavioral TherapyBehavioural
Psychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills
MusicBehavioural
Music therapist will teach a variety of ways that participants might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life.
Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts. Receives: Behavioral: Yoga |
| Cognitive Behavioral Therapy | Experimental | The goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life.
Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist. Receives: Behavioral: Cognitive Behavioral Therapy |
| Music | Experimental | The aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction.
Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week. Receives: Behavioral: Music |
| Standard of Care | No intervention | Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. For Months 1-3 participants will receive weekly online surveys as well as brief monthly calls checking-in and collecting their seizure frequency. Participants will continue to receive brief monthly calls for checking-in and collection of seizure frequency Months 4-12. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish. |
| Enhanced Standard of Care | No intervention | Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure Frequency
Reduction in seizure frequency
Measured: 3-12 months from beginning of intervention
Secondary outcomes (3)
Change in Stress
Change in stress as measured by improvement on the Patient Health Questionnaire-8.
Measured: 3-12 months from beginning of intervention
Change in Stress
Change in stress as measured by improvement on the Generalized Anxiety Disorder 7 scales.
Measured: 3-12 months from beginning of intervention
Quality of Life with Epilepsy
Change in reported Quality of Life as measured by improvement in the Quality of Life in Epilepsy assessment.
Measured: 3-12 months from beginning of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start11 Feb 2022
- Primary completion28 Feb 2026
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LifestyleStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imad Najm MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Imad Najm MD, The Cleveland Clinic
- Investigators
- Imad Najm, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283200
- Sponsor's protocol ID
- IRB 21-975
- Acronym
- LIFE
- Status last verified
- Jul 2026
- First submitted
- 11 Feb 2022
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a Healthy L.I.F.E: Lifestyle Interventions For Epilepsy
- ClinicalTrials.gov ID
- NCT05283200
- Acronym / sponsor ID
- LIFE / IRB 21-975
- Conditions
- Lifestyle
- Keywords
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Imad Najm MDUniversity, hospital or other
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 16 Mar 2022 (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.
A prospective controlled, randomized study to examine the effects of behavioral and wellness-based interventions on seizure frequency for adult patients with medication resistant epilepsy who are still experiencing 1 or more seizures per month.
Detailed description
In this prospective controlled, randomized study, investigators aim to assess the impact of integrative behavioral and wellness-based interventions on seizure frequency (primary outcome measure), stress, cognitive function, and quality of life (secondary outcome measures) in patients with difficult to treat epilepsy. The study team will accomplish these objectives through three active interventions that include: cognitive behavioral therapy (CBT), yoga therapy, and music therapy. This study will have two control groups who will continue with their standard of care as guided by their epilepsy provider. Investigators will measure the effects of our interventions using seizure diaries, cognitive assessments, and health and quality of life questionnaires. In this study, the study team will collect, process, store, and analyze human biospecimens of enrolled participants for research purposes to assess the potential biologic impact of our interventions. Collection, processing, storage, and data management of the biospecimens to be used for this study, and future studies, will be completed through Lerner Research Institute.
The CBT arm is currently closed to enrollment as of 8/14/2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaThe goal for the yoga intervention is to provide participants with instructor-guided safe, gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, anxiety symptoms, disability, and improve quality of life. Participants enrolled in the Yoga intervention group will receive one month of Instructor-Guided 70-minute virtual live yoga classes, twice per week, led by an experienced yoga therapist and co-instructor. During Months 2-3 participants in the Yoga Intervention will receive one 70-minute virtual live yoga class per week. Each session will have a set of specific poses, breathing exercises, meditation, and yoga philosophies developed by our yoga experts. |
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyThe goal of the Cognitive Behavioral Therapy (CBT) intervention is to provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills. We aim for participants to utilize the skills and strategies taught through this intervention to reduce seizure frequency, depression and anxiety symptoms, disability and improve quality of life. Participants enrolled in the CBT intervention group will receive 3 months of Instructor-Guided 90-minute, virtual group counseling session, once per week, led by a psychologist and a co-therapist. |
| Music | Experimental | Behavioral: MusicThe aim of this intervention is for participants to learn and develop skills to reduce stress which may, in turn, decrease seizure frequency and improve quality of life. Participants will be exposed to a variety of ways that they might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction. Participants enrolled in the Music Intervention group will receive one month of Instructor-Guided Intervention 70-minute virtual live music therapy sessions, twice per week, led by an experienced music therapist and co-instructor. An two months of a 70-minute virtual live music therapy session once per week. |
| Standard of Care | No intervention | –Participants randomized to the Standard of Care Control Group will receive their usual standard epilepsy care. For Months 1-3 participants will receive weekly online surveys as well as brief monthly calls checking-in and collecting their seizure frequency. Participants will continue to receive brief monthly calls for checking-in and collection of seizure frequency Months 4-12. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish. |
| Enhanced Standard of Care | No intervention | –Participants randomized to the Enhanced Standard of Care Control Group will receive their usual standard epilepsy care and weekly scheduled, scripted, follow-up phone calls from a study team member to check-in on their health, epilepsy management, and seizure frequency. Upon completion of the study, participants will receive access to online materials for all intervention modalities if they wish. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (ages 18-75) patients of the Cleveland Clinic Epilepsy Center with a confirmed diagnosis of epilepsy
- Ability to independently provide informed consent
- At the time of enrollment, patients must have had at least 1 seizure within the past 30 days
- No anticipated anti-seizure medication adjustments
- Internet access and the ability to participate in online video streaming
Key exclusion criteria (11 listed)
- Patients with a history of non-epileptic or psychogenic seizures
- Any patient that has engaged in yoga or music therapy within the last 6 months
- Currently enrolled in another interventional study for epilepsy at the time of enrollment.
- Anticipated or scheduled epilepsy surgery within 6 months
- Pending litigation related to the cause of epilepsy or current application for long term disability
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 |
|---|---|---|
| YogaYoga instructor will teach gentle yoga focused on meditation, breathing exercises, and mindfulness techniques to promote well-being and stress reduction | Behavioural | Yoga |
| Cognitive Behavioral TherapyPsychologist will provide patients with psycho-educational and behavioral health strategies to promote seizure prevention and stress management skills | Behavioural | Cognitive Behavioral Therapy |
| MusicMusic therapist will teach a variety of ways that participants might incorporate music into their daily lives as a means of self-expression, coping, and stress reduction. | Behavioural | Music |
Primary outcome
Seizure Frequency
Time frame: 3-12 months from beginning of intervention
Reduction in seizure frequency
3 secondary outcomes
Change in Stress
Time frame: 3-12 months from beginning of intervention
Change in Stress
Time frame: 3-12 months from beginning of intervention
Quality of Life with Epilepsy
Time frame: 3-12 months from beginning of intervention
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 15 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Imad Najm, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga, Cognitive Behavioral Therapy and Music in people with Lifestyle, run by Imad Najm MD 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 15 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure Frequency (time frame: 3-12 months from beginning of intervention). 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 15 Jul 2026.