Neurobehavioral Therapy for Epilepsy and Depression

Recruiting at 1 trial location

Overseen By Melissa Fadipe, MSN, APRN, FNP-C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Pregnancy, Suicidal ideation, Psychosis, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online therapy, Neurobehavioral Therapy, designed to assist veterans with epilepsy and depression. It aims to determine if veterans find this online group therapy, combined with text messaging, helpful and easy to use. Veterans who speak English, have internet access, and experience seizures and depression might be suitable candidates. The goal is to improve mental health and quality of life for those living with these conditions. As an unphased trial, this study offers veterans the chance to contribute to innovative research that could enhance mental health care for others facing similar challenges.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Neurobehavioral Therapy is safe for Veterans with epilepsy and major depressive disorder?

Research suggests that Neurobehavioral Therapy (NBT) might be safe for people with epilepsy and major depressive disorder (MDD). Although specific safety data for NBT in these conditions is lacking, similar therapies, like Cognitive Behavioral Therapy (CBT), are generally well-tolerated. Studies have shown that these therapies often improve or stabilize mental health issues without causing harm.

NBT doesn't involve medication; it focuses on changing behavior and thought patterns, usually avoiding the side effects associated with drugs. While direct safety data for NBT in epilepsy and depression is unavailable, the therapy's approach suggests it is likely safe for individuals with these conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurobehavioral therapy is unique because it offers a holistic approach that targets both epilepsy and depression simultaneously, addressing the interconnected nature of these conditions. Traditional treatments often separate the management of epilepsy from depression, focusing on medication for seizures and antidepressants for mood disorders. This therapy potentially enhances quality of life by integrating psychological and behavioral strategies with neurological care, aiming to improve both seizure control and emotional well-being. Researchers are excited because it could lead to more comprehensive and effective management, reducing the need for multiple medications and minimizing side effects.

What evidence suggests that Neurobehavioral Therapy might be an effective treatment for epilepsy and depression?

Research has shown that neurobehavioral therapy (NBT), which participants in this trial will receive, can help people with both epilepsy and depression. One study found that cognitive behavioral therapy (CBT), a type of NBT, reduced depression and anxiety in people with epilepsy. Another study discovered that NBT decreased the number of seizures and improved mental health and daily life. These results suggest that NBT might be a good option for treating both epilepsy and major depression simultaneously. ^{1 6 7 8 9}

Who Is on the Research Team?

Melissa Fadipe, MSN, APRN, FNP-C

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for veterans who have both epilepsy and major depressive disorder. It's designed to see if they can benefit from an online group therapy program that also uses text messaging.

Inclusion Criteria

Has home internet access

Has access to and familiarity in using a computer or tablet at least weekly

Has access to a mobile device with Short Message Service (SMS) text and picture capability

Exclusion Criteria

Have active psychosis

Veterans that have current suicidal ideation

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive online group Neuro-behavioral Therapy (NBT) with text messaging intervention

12 weeks

12 sessions (online)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Neurobehavioral Therapy

Trial Overview The study is testing the effectiveness of Neurobehavioral Therapy (NBT) delivered through an online platform with supplementary text messages, specifically aimed at helping veterans manage epilepsy and depression.

How Is the Trial Designed?

Group I: Neurobehavioral therapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Published Research Related to This Trial

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]

Psychobehavioral therapies, including cognitive-behavioral therapy (CBT) and mind-body interventions, have shown positive effects on the psychological well-being of people with epilepsy, but their impact on seizure control is inconsistent.

Future research should focus on well-designed, assessor-blinded randomized controlled trials with adequate sample sizes and clear therapeutic components to better evaluate the effectiveness of these therapies on both psychological and seizure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychobehavioral therapy for epilepsy. Tang, V., Michaelis, R., Kwan, P.[2018]

Cognitive Behavioral Therapy (CBT) shows potential efficacy for treating depression in people with epilepsy, with positive effects reported in three out of six randomized controlled trials (RCTs) that specifically tailored CBT to address depression.

Interventions focused on improving depression rather than seizure control were more effective, indicating that CBT should be specifically designed to target depressive symptoms in this population, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for depression in people with epilepsy: a systematic review. Gandy, M., Sharpe, L., Perry, KN.[2018]

Understanding the peri-ictal period (the time surrounding a seizure) is crucial as it can lead to better treatment options for people with epilepsy, who often experience significant behavioral and cognitive changes during this time.

The review highlights that both acute and delayed emotional and cognitive changes after seizures can contribute to complications like psychosis and depression, suggesting that addressing these issues may improve overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-Ictal Behavioral and Cognitive Changes. Boylan, LS.[2019]

A significant number of epilepsy patients experience neurobehavioral issues, including cognitive dysfunction (like attention and memory deficits) and psychiatric disturbances (such as depression and anxiety), which can greatly affect their daily lives.

The article reviews various risk factors and treatment options for these cognitive and psychiatric changes, highlighting the importance of understanding the impact of epilepsy beyond seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive deficits in epilepsy and contribution to psychopathology. Perrine, K., Kiolbasa, T.[2022]

Cognitive behavioral therapy (CBT) significantly improves depression in patients with epilepsy, with an effect size of 0.36, and this improvement is maintained during follow-up with an effect size of 0.47.

CBT also positively impacts the quality of life in patients with epilepsy, showing an effect size of 0.34, but it does not have a significant effect on seizure control, indicating its primary benefit is in mental health rather than seizure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavior therapy for depression in people with epilepsy: A systematic review and meta-analysis. Li, D., Song, Y., Zhang, S., et al.[2023]

Patients with epilepsy are at a higher risk of depression, and neuroimaging studies show specific brain activity patterns associated with depression, including hypoactivity in the frontal cortex and hippocampus.

Cognitive Behavioral Therapy (CBT) may positively impact brain regions affected by both epilepsy and depression, suggesting it could be beneficial for these patients, although more research is needed to confirm its effectiveness as a treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it time to consider cognitive behavioral therapy for persons with epilepsy? Clues from pathophysiology, treatment and functional neuroimaging. Charyton, C., Elliott, JO., Moore, JL., et al.[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]

Patients with epilepsy frequently experience neurobehavioral disorders that affect cognitive functions such as attention, memory, and social skills, which can significantly impair their quality of life.

While reducing seizure frequency and medication burden can help alleviate some cognitive issues, many behavioral disorders like depression and anxiety respond well to pharmacotherapy and psychotherapy, yet they often remain unrecognized and undertreated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy for neurobehavioral disorders in epilepsy. Devinsky, O.[2005]

Anti-epileptic drugs (AEDs) are effective for controlling seizures but can lead to adverse effects like psychosis and depression, especially in patients with existing psychiatric conditions or limbic system abnormalities.

Using AEDs at lower doses and with slow titration can help minimize behavioral side effects, highlighting the importance of careful patient selection and monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiepileptic drugs and psychopathology of epilepsy: an update. Mula, M., Monaco, F.[2009]

In a study of 355 patients on chronic antiepileptic drugs followed for an average of 11 months, 41.6% experienced adverse drug reactions (ADRs), but the frequency of reports decreased over time, indicating improved management of side effects.

The percentage of patients who became seizure-free increased significantly from 24.5% to 42.8%, suggesting that intensive monitoring of ADRs not only helps in identifying drug toxicity but also contributes to better overall epilepsy management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse reactions to antiepileptic drugs: a follow-up study of 355 patients with chronic antiepileptic drug treatment. Collaborative Group for Epidemiology of Epilepsy. [2019]

In a study of 11 patients with complex partial epilepsy, a short-term multidisciplinary treatment approach led to a complete cessation of seizures in nine patients and a significant reduction in seizure frequency for the remaining two, assessed 24 months post-treatment.

The treatment not only reduced seizure frequency but also improved professional achievements in fields like the arts and computer sciences, while allowing for a reduction in medication dosages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. Reiter, JM., Andrews, DJ.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12345471/

a systematic review and network meta-analysis - PMC A network meta-analysis of 41 RCTs involving 4,422 participants demonstrated that psychotherapy (PT) was significantly more effective than the ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38183927/

Effectiveness of CBT for reducing depression and anxiety ... The result of our study showed that Cognitive behavioral therapy is a superior therapy for treating anxiety and depression in epilepsy patients.

3. clinicaltrial.be clinicaltrial.be/en/details/459326?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Neurobehavioral Therapy For Epilepsy And Major ... The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505023005279

Effectiveness of CBT for reducing depression and anxiety ... The result of our study showed that Cognitive behavioral therapy is a superior therapy for treating anxiety and depression in epilepsy patients.

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/epi.18137

One‐year follow‐up of neurobehavioral therapy in ... The primary outcome was change in seizure frequency; secondary outcomes were changes in mental health, TBI-related symptoms, disability, and ...

6. withpower.com withpower.com/trial/phase-epilepsy-10-2024-061d3

Neurobehavioral Therapy for Epilepsy and Depression There is no specific safety data available for Neurobehavioral Therapy for epilepsy and depression, but related therapies like Cognitive Behavioral Therapy ...

7. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2604239

Association of Depression With Epilepsy and Seizure ... We found that worsening depression appears to augment the risk of epilepsy and the odds of worse seizure outcomes.

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/epi.18505?af=R

Neuropsychological and neurobehavioral outcomes of ... Intellectual functioning, cognitive functioning, depression, anxiety, and quality of life either improved or remained stable across the included ...

9. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(25)00310-5/fulltext

Findings from a German multicentre cross-sectional study People with epilepsy (PWE) bear a 3–5-fold higher risk of developing psychiatric illnesses such as depression or anxiety disorders. Our study ...