Recruiting

Neurobehavioral Therapy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06695767

Conditions

Major Depressive Disorder

Epilepsy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Neurobehavioral therapy

Study Details

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

Study ID

NCT06695767

Start date

Dec 19, 2024

Status verified date

Jan, 2025

Completion date

Apr 1, 2025

Anticipated

Primary completion date

Feb 6, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Neurobehavioral therapy

Interventions

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.

Primary outcome measure

  • Enrollment rate [ Time Frame: post intervention (14 weeks after baseline) ]
  • Retention rate [ Time Frame: post intervention (14 weeks after baseline) ]
  • Session attendance rate (proportion of sessions attended) [ Time Frame: post intervention (14 weeks after baseline) ]
  • Homework completion rate (proportion of homework assignments completed) [ Time Frame: post intervention (14 weeks after baseline) ]
  • User satisfaction as assessed by The Participant Satisfaction Survey [ Time Frame: post intervention (14 weeks after baseline) ]

Central Contacts and Locations

Central contacts

Melissa Fadipe, MSN, APRN, FNP-C

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

Jennifer Beauchamp

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

Locations

Michael E. DeBakey VA Medical Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Melissa Fadipe, MSN, APRN, FNP-C

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

Jennifer Beauchamp

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

The University of Texas health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Melissa Fadipe, MSN, APRN, FNP-C

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

Jennifer Beauchamp

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jan 9, 2025

Last verified

Jan, 2025

Keywords

  • veterans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2025-01-09.