Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

NCT ID: NCT06695767

Last Updated: 2025-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-19

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Neurobehavioral therapy

Group Type EXPERIMENTAL

Neurobehavioral therapy

Intervention Type BEHAVIORAL

Participants will receive an introduction session and 12 1-hour long online sessions once per week for a total of 12 weeks that are guided by the investigator who is trained in NBT.Participants will engage in tools to aid in assuming control over their seizures; contextualize their environment; identify moods, situations, and thoughts; train healthy communication and support seeking; understand central nervous system medications and seizures; conduct a functional behavioral analysis; learn relaxation techniques; examine external stressors and internal triggers; and prepare for life after the intervention. Participants will be asked to complete weekly homework, thought records, seizure logs that are found in their workbooks and to engage in journal entries.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Neurobehavioral therapy

Participants will receive an introduction session and 12 1-hour long online sessions once per week for a total of 12 weeks that are guided by the investigator who is trained in NBT.Participants will engage in tools to aid in assuming control over their seizures; contextualize their environment; identify moods, situations, and thoughts; train healthy communication and support seeking; understand central nervous system medications and seizures; conduct a functional behavioral analysis; learn relaxation techniques; examine external stressors and internal triggers; and prepare for life after the intervention. Participants will be asked to complete weekly homework, thought records, seizure logs that are found in their workbooks and to engage in journal entries.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* English speaking veterans
* has home internet access
* has access to and familiarity in using a computer or tablet at least weekly
* Asymptomatic patients with chronic conditions
* has access to a mobile device with Short Message Service (SMS) text and picture capability
* has an active clinical diagnosis of major depressive disorder based on the International Classification of Diseases, 10th version (ICD-10)
* has an ICD-10 diagnosis of epilepsy with at least one seizure documented within the last five years

Exclusion Criteria

* pregnancy
* Veterans that have current suicidal ideation
* have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melissa Fadipe

Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Melissa Fadipe, MSN, APRN, FNP-C

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michael E. DeBakey VA Medical Center

Houston, Texas, United States

Site Status RECRUITING

The University of Texas health Science Center at Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Melissa Fadipe, MSN, APRN, FNP-C

Role: CONTACT

(713) 825-7237

Jennifer Beauchamp

Role: CONTACT

(713) 500-2114

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Melissa Fadipe, MSN, APRN, FNP-C

Role: primary

(713) 825-7237

Jennifer Beauchamp

Role: backup

(713) 500-2114

Melissa Fadipe, MSN, APRN, FNP-C

Role: primary

(713) 825-7237

Jennifer Beauchamp

Role: backup

(713) 500-2114

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-53437

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Post-TBI Depression
NCT00211835 COMPLETED NA