Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

Not Applicable

Recruiting

• Conditions: Major Depressive Disorder; Epilepsy

• Registration Number: NCT06695767
• Lead Sponsor: The University of Texas Health Science Center, Houston

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-09
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-19
• Study Start: 2024-12-19
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-02-06
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Enrollment rate	post intervention (14 weeks after baseline)	This is defined as the number enrolled divided by the number of eligible participants screened
Retention rate	post intervention (14 weeks after baseline)	This is defined as the number completing the study/number enrolled at 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	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

Secondary Outcome Measures

Name	Time	Method
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),	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
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)	This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life.
Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)	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.
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)	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

Trial Locations

Locations (2)

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

The University of Texas health Science Center at Houston; 🇺🇸 Houston, Texas, United States