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Recruiting NCT06695767

Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

No phase Interventional Major Depressive Disorder Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurobehavioral therapy.
Who it may be relevant to
Registry conditions: Major Depressive Disorder, Epilepsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • 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 relax

Primary outcome measures

  • 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)]
Secondary outcome measures (4)
  • Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9), [Time frame: 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)]
  • Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC) [Time frame: 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Michael E. DeBakey VA Medical Center — Houston
  • The University of Texas health Science Center at Houston — Houston

Identifiers

NCT: NCT06695767 · H-53437

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗