Major Depressive DisorderNCT06695767
Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
A study testing Neurobehavioral therapy in people with Major Depressive Disorder and Epilepsy, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Epilepsy
- What is being tested?
- Neurobehavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Dec 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- Veterans that have current suicidal ideation
- have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Melissa Fadipe, MSN, APRN, FNP-C, (713) 825-7237, Melissa.F.Fadipe@uth.tmc.edu
Jennifer Beauchamp, (713) 500-2114, Jennifer.E.Beauchamp@uth.tmc.edu
- Recruiting
The University of Texas health Science Center at Houston
Houston, Texas, 77030
Melissa Fadipe, MSN, APRN, FNP-C, (713) 825-7237, Melissa.F.Fadipe@uth.tmc.edu
Jennifer Beauchamp, (713) 500-2114, Jennifer.E.Beauchamp@uth.tmc.edu
About this study
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
- Being tested
- Neurobehavioral therapy
- Keywords
- veterans
- Medical subject headings
- Depressive Disorder, Major, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurobehavioral therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Neurobehavioral therapy | Experimental | Not described Receives: Behavioral: Neurobehavioral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
This is defined as the number enrolled divided by the number of eligible participants screened
Measured: post intervention (14 weeks after baseline)
Retention rate
This is defined as the number completing the study/number enrolled at baseline
Measured: post intervention (14 weeks after baseline)
Session attendance rate (proportion of sessions attended)
Measured: post intervention (14 weeks after baseline)
Homework completion rate (proportion of homework assignments completed)
Measured: post intervention (14 weeks after baseline)
User satisfaction as assessed by The Participant Satisfaction Survey
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
Measured: post intervention (14 weeks after baseline)
Secondary outcomes (4)
Change in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9),
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
Measured: 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)
This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life.
Measured: baseline, end of session 12(12 weeks form baseline)
Change resilience as assessed by the Connor-Davidson Resilience Scale (CD-RISC)
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.
Measured: 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)
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
Measured: baseline, end of session 12(12 weeks form baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start19 Dec 2024
- Primary completion6 Feb 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Fadipe, The University of Texas Health Science Center, Houston
- Investigators
- Melissa Fadipe, MSN, APRN, FNP-C, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695767
- Sponsor's protocol ID
- H-53437
- Status last verified
- Jan 2025
- First submitted
- 9 Nov 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Therapy For Epilepsy And Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06695767
- Acronym / sponsor ID
- H-53437
- Conditions
- Major Depressive Disorder, Epilepsy
- Keywords
- veterans
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 6 Feb 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurobehavioral therapy | Experimental | Behavioral: Neurobehavioral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- Veterans that have current suicidal ideation
- have active psychosis; and have an ICD-10 diagnosis of psychogenic non-epileptic seizures or conversion disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurobehavioral therapyParticipants 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. | Behavioural | Neurobehavioral therapy |
Primary outcome
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
Retention rate
Time frame: 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)
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)
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
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melissa Fadipe, MSN, APRN, FNP-C principal investigator
The University of Texas Health Science Center, Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurobehavioral therapy in people with Major Depressive Disorder and Epilepsy, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Fadipe, MSN, APRN, FNP-C ((713) 825-7237, Melissa.F.Fadipe@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: post intervention (14 weeks after baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.