Lifestyle Interventions for Epilepsy

(LIFE Trial)

Overseen By Arden Bischof, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Imad Najm MD

Disqualifiers: Non-epileptic seizures, Chronic illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

1000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop your current medications. In fact, it mentions no anticipated anti-seizure medication adjustments, suggesting you can continue your current treatment.

What data supports the effectiveness of the treatment Lifestyle Interventions for Epilepsy?

Research shows that psychological treatments like Acceptance and Commitment Therapy (ACT), yoga, and cognitive behavior therapy can help reduce seizure frequency and improve quality of life for people with epilepsy. ^{1 2 3 4 5}

Is lifestyle intervention therapy safe for humans?

Research on therapies like cognitive behavioral therapy (CBT), mindfulness meditation, and yoga suggests they are generally safe for humans, as they are commonly used for conditions like PTSD and panic disorder without significant safety concerns. ^{6 7 8 9 10}

How does the lifestyle intervention treatment for epilepsy differ from other treatments?

The lifestyle intervention for epilepsy is unique because it focuses on comprehensive lifestyle changes, such as diet, exercise, and stress management, rather than relying solely on medication. This approach is similar to lifestyle modifications used in other conditions like heart disease and hypertension, aiming to improve overall health and quality of life. ^{11 12 13 14 15}

Research Team

Imad Najm, MD

Principal Investigator

The Cleveland Clinic

Eligibility Criteria

Adults aged 18-75 with medication-resistant epilepsy, experiencing at least one seizure a month, can join this study. They must be able to consent and participate in yoga, music therapy or CBT without changing their seizure meds. Excluded are those with non-epileptic seizures, recent similar therapy, other trials' participation, serious chronic illnesses that affect safety in the study, intensive treatments like chemotherapy, pregnancy/postpartum status within six weeks.

Inclusion Criteria

I can understand and agree to the study on my own.

I am willing to try yoga, music therapy, or cognitive behavioral therapy.

I am between 18 and 75 years old and have been diagnosed with epilepsy by the Cleveland Clinic.

Exclusion Criteria

You are unable to see.

I have seizures triggered by music.

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 safely or effectively participate in the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral and wellness-based interventions including yoga, cognitive behavioral therapy, and music therapy to reduce seizure frequency and improve quality of life

3 months

Weekly virtual sessions

Follow-up

Participants are monitored for seizure frequency, stress, and quality of life improvements

9 months

Monthly check-ins

Treatment Details

Interventions

• Cognitive Behavioral Therapy
• Music
• Yoga

Trial Overview The trial is testing if yoga, cognitive behavioral therapy (CBT), or music can help reduce seizures in adults who don't respond well to epilepsy drugs. Participants will be randomly assigned to one of these interventions and monitored for changes in their seizure frequency.

Participant Groups

Group I: Yoga Experimental Treatment 1 Intervention

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.

Group II: Music Experimental Treatment 1 Intervention

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.

Group III: Cognitive Behavioral Therapy Experimental Treatment 1 Intervention

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.

Group IV: Standard of Care Active Control 1 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.

Group V: Enhanced Standard of Care Active Control 1 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 Is Running the Clinical Trial?

Imad Najm MD

Lead Sponsor

Trials

1

Recruited

1,000+

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Findings from Research

A randomized controlled trial with 18 participants showed that both Acceptance and Commitment Therapy (ACT) and yoga significantly reduced seizure frequency and duration in individuals with drug-refractory epilepsy over a 12-month period.

ACT was found to be more effective than yoga in reducing the seizure index and improving quality of life, as measured by the WHOQOL-BREF, while both therapies positively impacted quality of life according to different assessment tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy and yoga for drug-refractory epilepsy: a randomized controlled trial. Lundgren, T., Dahl, J., Yardi, N., et al.[2022]

The review of psychological interventions for epilepsy, including relaxation therapy and cognitive behavioral therapy, found no significant evidence that these methods effectively reduce seizure frequency, based on three small trials with a total of 50 participants.

While some psychological methods showed potential benefits for improving anxiety and understanding of epilepsy, the overall lack of robust evidence and methodological issues in the studies indicate that more rigorous trials are necessary to determine their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. Ramaratnam, S., Baker, GA., Goldstein, L.[2019]

The review of psychological interventions for epilepsy, including relaxation therapy and cognitive behavioral therapy, found no significant evidence that these methods effectively reduce seizure frequency, based on three small trials involving 50 patients.

While some psychological methods showed potential benefits for improving anxiety, depression, and knowledge about epilepsy, the overall lack of robust evidence and methodological issues in the studies indicate that more rigorous trials are necessary to determine their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. Ramaratnam, S., Baker, GA., Goldstein, L.[2018]

A psychological treatment program combining acceptance and commitment therapy (ACT) with behavioral seizure control was evaluated in a randomized controlled trial with 27 participants suffering from drug-refractory epilepsy, showing significant improvements in quality of life and seizure control compared to supportive therapy.

The ACT group demonstrated lasting benefits at six and twelve months, suggesting that this short-term psychotherapy approach, alongside anticonvulsant medications, may help reduce long-term disability associated with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa--a pilot study. Lundgren, T., Dahl, J., Melin, L., et al.[2022]

The review of psychological interventions for epilepsy, including relaxation therapy and cognitive behavioral therapy (CBT), found no significant evidence that these methods effectively reduce seizure frequency, with most studies being of poor quality.

While some studies suggested CBT may improve quality of life and reduce depression in individuals with epilepsy, the overall lack of reliable evidence indicates that more rigorous trials are necessary to determine the efficacy of these psychological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. Ramaratnam, S., Baker, GA., Goldstein, LH.[2020]

The Bergen 4-day treatment (B4DT) significantly reduced panic disorder symptoms in 30 patients, with a large effect size (d = 4.32) post-treatment and an even larger effect (d = 4.91) at the 3-month follow-up, indicating lasting benefits.

80% of patients achieved remission after treatment, and high treatment satisfaction was reported, with no dropouts, suggesting that B4DT is a feasible and effective intervention for panic disorder and associated anxiety and depression symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Bergen 4-day treatment for panic disorder: replication and implementation in a new clinic. Iversen, HM., Eide, TO., Harvold, M., et al.[2022]

A randomized clinical trial involving 135 patients will compare the online efficacy of trial-based cognitive therapy (TBCT), mindfulness-based health promotion (MBHP), and positive psychotherapy (PPT) in reducing PTSD symptoms during the COVID-19 pandemic.

The study aims to show that all three therapies can effectively reduce PTSD symptoms, anxiety, and depression, with no significant differences expected among them, highlighting the potential for flexible online treatment options for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. Duran, ÉP., Hemanny, C., Vieira, R., et al.[2022]

This randomized controlled trial will assess the effectiveness of a 10-week internet-delivered cognitive behavioral therapy (iCBT) program for treating posttraumatic stress disorder (PTSD) in a sample of at least 72 participants, aiming to replicate previous positive findings.

The study will also explore how changes in PTSD symptoms relate to factors like intolerance of uncertainty and emotion regulation, potentially revealing important mechanisms behind the effectiveness of CBT for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial. Allen, AR., Newby, JM., Smith, J., et al.[2022]

A study involving 85 traumatized refugees showed that a manualized cognitive behavioral therapy (CBT) incorporating exposure therapy, mindfulness, and acceptance and commitment therapy led to positive treatment outcomes, with 42% of patients benefiting significantly from structured CBT.

The effectiveness of the therapy was enhanced by using multiple methods and encouraging patients to complete homework assignments, indicating that refugees can actively participate in structured CBT despite their challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral psychotherapeutic treatment at a psychiatric trauma clinic for refugees: description and evaluation. Buhmann, C., Andersen, I., Mortensen, EL., et al.[2021]

An 8-week web-based cognitive behavioral therapy program combined with mindfulness and yoga showed significant reductions in PTSD symptoms (effect size d=1.60), depression, anxiety, and improvements in mindfulness among 22 participants aged 18-35.

Participants also exhibited a notable decrease in peak pupil dilation, indicating healthier autonomic functioning, although heart rate variability did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. Kirk, MA., Taha, B., Dang, K., et al.[2022]

A 6-week lifestyle intervention program for 15 German patients, which included a low-fat vegetarian diet and aerobic exercises, led to significant dietary changes and improved quality of life, demonstrating its feasibility in a rehabilitation setting.

Despite both the intervention and control groups receiving the same lipid-lowering medication (Pravastatin), the lifestyle changes did not provide additional benefits in lowering lipid levels beyond what the medication achieved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Life style changes in patients with myocardial infarct in the framework of intramural and ambulatory rehabilitation--results of a German pilot study]. Scherwitz, LW., Brusis, OA., Kesten, D., et al.[2013]

Lifestyle modifications, such as weight loss, regular exercise, reduced alcohol intake, and dietary changes, are safe and effective treatments for hypertension in elderly patients, yet they are often underutilized by healthcare providers.

These lifestyle changes not only lower blood pressure but also decrease the risk and severity of related health issues, making them a preferable option compared to medication, with minimal contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evidence for Lifestyle Modification in Lowering Blood Pressure in the Elderly. Stanton, JA., Lowenthal, DT.[2019]

Incorporating interpersonal communication skills, such as motivational interviewing and brief action planning (BAP), can significantly enhance lifestyle medicine practices by helping patients adopt and maintain healthier behaviors like improved diet and exercise.

Motivational interviewing focuses on engaging patients through empathy and active listening, while BAP provides a structured approach for setting specific, achievable health goals, making it easier for patients to commit to and follow through on their health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using motivational interviewing and brief action planning for adopting and maintaining positive health behaviors. Cole, SA., Sannidhi, D., Jadotte, YT., et al.[2023]

The PHLAME study is evaluating two different strategies to improve nutrition and physical activity among firefighters: a team-centered approach and an individual one-on-one approach, comparing both to a usual-care control group.

If successful, the team-centered model could be a cost-effective way to promote healthier behaviors in firefighters and potentially in other team environments, while the individual approach uses established counseling techniques to support personal behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME). Moe, EL., Elliot, DL., Goldberg, L., et al.[2019]

Unhealthy lifestyle behaviors contribute to approximately 63% of all deaths globally, highlighting the urgent need for lifestyle medicine to address chronic diseases.

Adhering to 'low-risk lifestyle' behaviors and ideal cardiovascular health metrics has been shown to improve mortality rates, yet the prevalence of healthy living in the population remains low, indicating significant challenges in implementing lifestyle medicine programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle medicine: the future of chronic disease management. Kushner, RF., Sorensen, KW.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy and yoga for drug-refractory epilepsy: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of acceptance and commitment therapy for drug refractory epilepsy: a randomized controlled trial in South Africa--a pilot study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Psychological treatments for epilepsy. [2020]

6. England pubmed.ncbi.nlm.nih.gov

The Bergen 4-day treatment for panic disorder: replication and implementation in a new clinic. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

A Randomized Clinical Trial to Assess the Efficacy of Online-Treatment with Trial-Based Cognitive Therapy, Mindfulness-Based Health Promotion and Positive Psychotherapy for Post-Traumatic Stress Disorder during the COVID-19 Pandemic: A Study Protocol. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Internet-based cognitive behavioural therapy (iCBT) for posttraumatic stress disorder versus waitlist control: study protocol for a randomised controlled trial. [2022]

9. Denmark pubmed.ncbi.nlm.nih.gov

Cognitive behavioral psychotherapeutic treatment at a psychiatric trauma clinic for refugees: description and evaluation. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

A Web-Based Cognitive Behavioral Therapy, Mindfulness Meditation, and Yoga Intervention for Posttraumatic Stress Disorder: Single-Arm Experimental Clinical Trial. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Life style changes in patients with myocardial infarct in the framework of intramural and ambulatory rehabilitation--results of a German pilot study]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

The Evidence for Lifestyle Modification in Lowering Blood Pressure in the Elderly. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Using motivational interviewing and brief action planning for adopting and maintaining positive health behaviors. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Promoting Healthy Lifestyles: Alternative Models' Effects (PHLAME). [2019]

15. England pubmed.ncbi.nlm.nih.gov

Lifestyle medicine: the future of chronic disease management. [2013]