Clinical trial NCT06695767: Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
Official title: Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Epilepsy
Keywords: veterans
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment rate
timeFrame: post intervention (14 weeks after baseline)
measure: Retention rate
timeFrame: post intervention (14 weeks after baseline)
measure: Session attendance rate (proportion of sessions attended)
timeFrame: post intervention (14 weeks after baseline)
measure: Homework completion rate (proportion of homework assignments completed)
timeFrame: post intervention (14 weeks after baseline)
measure: User satisfaction as assessed by The Participant Satisfaction Survey
timeFrame: post intervention (14 weeks after baseline)
Secondary outcomes:
measure: Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),
timeFrame: baseline, end of session 12 (12 weeks form baseline)
measure: Change in quality of Life as assessed by the Quality of Life in Epilepsy Inventory-10 (QOLIE-10)
timeFrame: baseline, end of session 12(12 weeks form baseline)
measure: Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: baseline, end of session 12(12 weeks form baseline)
measure: Change in efficacy in the self management of epilepsy as assessed by the Epilepsy Self-Efficacy Scale (ESES)
timeFrame: baseline, end of session 12(12 weeks form baseline)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Melissa Fadipe, MSN, APRN, FNP-C
role: PRINCIPAL_INVESTIGATOR
References: