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NCT Number: NCT06695767

Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder

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).

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Key information

Conditions

Major Depressive Disorder Brain Diseases Central Nervous System Diseases Depressive Disorder Depressive Disorder, Major Epilepsy Mental Disorders Mood Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Enrollment rate

    Time frame: post intervention (14 weeks after baseline)

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

  2. Retention rate

    Time frame: post intervention (14 weeks after baseline)

    This is defined as the number completing the study/number enrolled at baseline

  3. Session attendance rate (proportion of sessions attended)

    Time frame: post intervention (14 weeks after baseline)

  4. Homework completion rate (proportion of homework assignments completed)

    Time frame: post intervention (14 weeks after baseline)

  5. User satisfaction as assessed by The Participant Satisfaction Survey

    Time frame: 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 outcomes

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

    Time frame: 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

  2. 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)

    This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life.

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

    Time frame: 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.

  4. 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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Beauchamp

CONTACT

[email protected]

(713) 500-2114

Melissa Fadipe, MSN, APRN, FNP-C

CONTACT

[email protected]

(713) 825-7237

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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