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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurobehavioral therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | This is defined as the number enrolled divided by the number of eligible participants screened | post intervention (14 weeks after baseline) |
| Retention rate | This is defined as the number completing the study/number enrolled at baseline | post intervention (14 weeks after baseline) |
| Session attendance rate (proportion of sessions attended) | post intervention (14 weeks after baseline) | |
| Homework completion rate (proportion of homework assignments completed) | 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 | post intervention (14 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Fadipe, MSN, APRN, FNP-C | Contact | (713) 825-7237 | Melissa.F.Fadipe@uth.tmc.edu | |
| Jennifer Beauchamp | Contact | (713) 500-2114 | Jennifer.E.Beauchamp@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melissa Fadipe, MSN, APRN, FNP-C | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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This is a 10 item questionnaire , with scores ranging from 0-100, with a higher score indicating better quality of life. |
| 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. | 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 | baseline, end of session 12(12 weeks form baseline) |
| The University of Texas health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |