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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the feasibility and acceptability of an online group Neuro-behavioral Therapy (NBT) with text messaging intervention for Veterans with epilepsy and major depressive disorder (MDD).

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 data supports the effectiveness of the treatment Neurobehavioral Therapy for epilepsy and depression?

A study on a neurobehavioral treatment approach for complex partial epilepsy showed that patients experienced a significant reduction in seizure frequency and improvements in professional achievement and medication dosage. Additionally, cognitive-behavioral therapy (CBT), a component of neurobehavioral therapy, has shown positive effects on depression in people with epilepsy in some studies. ^{1 2 3 4 5}

Is Neurobehavioral Therapy safe for humans?

There is no specific safety data available for Neurobehavioral Therapy for epilepsy and depression, but related therapies like Cognitive Behavioral Therapy (CBT) have been studied and are generally considered safe for treating depression and epilepsy. More research is needed to confirm the safety of Neurobehavioral Therapy specifically. ^{2 6 7 8 9}

How is Neurobehavioral Therapy different from other treatments for epilepsy and depression?

Neurobehavioral Therapy is unique because it focuses on improving both psychological well-being and seizure control through behavioral approaches, cognitive-behavioral therapy (CBT), and mind-body interventions. Unlike standard drug treatments, it aims to address the bidirectional interaction between seizures and psychological states, although its effects on seizure control can be inconsistent. ^{1 3 10 11 12}

Research Team

Melissa Fadipe, MSN, APRN, FNP-C

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Cognitive behavior therapy for depression in people with epilepsy: A systematic review and meta-analysis. [2023]

2. 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]

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

Psychobehavioral therapy for epilepsy. [2018]

4. England pubmed.ncbi.nlm.nih.gov

A neurobehavioral approach for treatment of complex partial epilepsy: efficacy. [2018]

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

Cognitive behavior therapy for depression in people with epilepsy: a systematic review. [2018]

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

Antiepileptic drugs and psychopathology of epilepsy: an update. [2009]

7. United States 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]

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

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

9. England pubmed.ncbi.nlm.nih.gov

Is it time to consider cognitive behavioral therapy for persons with epilepsy? Clues from pathophysiology, treatment and functional neuroimaging. [2018]

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

Therapy for neurobehavioral disorders in epilepsy. [2005]

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

Cognitive deficits in epilepsy and contribution to psychopathology. [2022]

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

Peri-Ictal Behavioral and Cognitive Changes. [2019]