Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

January 8, 2025 updated by: Melissa Fadipe, The University of Texas Health Science Center, Houston
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurobehavioral therapy
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrollment rate
Time Frame: post intervention (14 weeks after baseline)
This is defined as the number enrolled divided by the number of eligible participants screened
post intervention (14 weeks after baseline)
Retention rate
Time Frame: post intervention (14 weeks after baseline)
This is defined as the number completing the study/number enrolled at baseline
post intervention (14 weeks after baseline)
Session attendance rate (proportion of sessions attended)
Time Frame: post intervention (14 weeks after baseline)
post intervention (14 weeks after baseline)
Homework completion rate (proportion of homework assignments completed)
Time Frame: post intervention (14 weeks after baseline)
post intervention (14 weeks after baseline)
User satisfaction as assessed by The Participant Satisfaction Survey
Time Frame: post intervention (14 weeks after baseline)
This is a 16 item questionnaire and the first 10 questions are scored from 1( strongly disagree)to 5(strongly agree) for a maximum score of 50, higher score indicating better outcome
post intervention (14 weeks after baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),
Time Frame: baseline, end of session 12 (12 weeks form baseline)
This is a 9 item questionnaire and each is scored from 0(not at all) to 3(Nearly every day), for a score range of 1-27, higher score indicating worse outcome
baseline, end of session 12 (12 weeks form baseline)
Change in quality of Life as assessed by the Quality of Life in Epilepsy Inventory-10 (QOLIE-10)
Time Frame: baseline, end of session 12(12 weeks form baseline)
This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life.
baseline, end of session 12(12 weeks form baseline)
Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: baseline, end of session 12(12 weeks form baseline)
This is a 25 item questionnaire, each rated on a 5-point scale from 0(not true at all) to 4(true nearly all the time), with higher scores reflecting greater resilience.
baseline, end of session 12(12 weeks form baseline)
Change in efficacy in the self management of epilepsy as assessed by the Epilepsy Self-Efficacy Scale (ESES)
Time Frame: baseline, end of session 12(12 weeks form baseline)
This is a 33 item questionnaire , rated on a 11-point Likert scale, ranging from 0(I cannot do it at all) to 10(sure I can do) for a maximum score of 330, higher score indicating better outcome
baseline, end of session 12(12 weeks form baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Melissa Fadipe, MSN, APRN, FNP-C, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

February 6, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

November 9, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-53437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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