Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

NCT06695767 | Recruiting

• 1 other identifier: H-53437
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Major Depressive Disorder; Epilepsy

Keywords

veterans

Outcome Measures

Primary Outcomes (5)

• Enrollment rate

  This is defined as the number enrolled divided by the number of eligible participants screened

  post intervention (14 weeks after baseline)

• Retention rate

  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)

  post intervention (14 weeks after baseline)

• Homework completion rate (proportion of homework assignments completed)

  post intervention (14 weeks after baseline)

• User satisfaction as assessed by The Participant Satisfaction Survey

  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 Outcomes (4)

• Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),

  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)

  baseline, end of session 12(12 weeks form baseline)

• Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)

  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)

  baseline, end of session 12(12 weeks form baseline)

Study Arms (1)

Neurobehavioral therapy

EXPERIMENTAL

Behavioral: Neurobehavioral therapy

Interventions

Neurobehavioral therapy 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.

Neurobehavioral therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

The University of Texas health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Epilepsy

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Melissa Fadipe, MSN, APRN, FNP-C

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Fadipe, MSN, APRN, FNP-C

CONTACT

(713) 825-7237; Melissa.F.Fadipe@uth.tmc.edu

Jennifer Beauchamp

CONTACT

(713) 500-2114; Jennifer.E.Beauchamp@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 19, 2024
• Study Start: December 19, 2024
• Primary Completion: February 6, 2025
• Study Completion: April 1, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)