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Telephone-Based Support Programs for Epilepsy
N/A
Recruiting
Led By Tanya Spruill
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with epilepsy for at least one year
Adult (≥18 years of age)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 3 month visit, 6 month visit, 12 month visit
Awards & highlights
Study Summary
This trial is comparing two different ways to help people with epilepsy who have depression. One is called UPLIFT and the other is called BOOST. They will be compared to see which one is better at helping with depression symptoms, quality of life, and seizures.
Who is the study for?
This trial is for adults over 18 with epilepsy diagnosed at least a year ago, who speak English or Spanish and are experiencing mild to moderate depression. They must be willing to have their group phone sessions recorded. People with severe depression, suicidal thoughts, significant cognitive issues, or active psychotic disorders cannot participate.Check my eligibility
What is being tested?
The study compares two telephone-based programs: UPLIFT (depression self-management) and BOOST (support groups), each lasting 8 weeks with one-hour weekly sessions. The goal is to see which program better reduces depressive symptoms and improves quality of life and seizure control in people with epilepsy over a year.See study design
What are the potential side effects?
Since the interventions involve psychological support rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort discussing personal issues during sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with epilepsy for over a year.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit, 3 month visit, 6 month visit, 12 month visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 3 month visit, 6 month visit, 12 month visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Presence of clinically significant depressive symptoms
Secondary outcome measures
Change in depressive symptom severity
Change in disease-specific quality of life
Change in general health-related quality of life
+2 moreOther outcome measures
Change in anxiety
Change in epilepsy self management
Change in healthcare utilization
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)Experimental Treatment1 Intervention
UPLIFT is a telephone-based depression self-management program for people with epilepsy.
Group II: Arm 2: BOOST (Bringing Out Our Strength Together)Active Control1 Intervention
BOOST is a telephone-based support program for people with epilepsy.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,373 Previous Clinical Trials
841,004 Total Patients Enrolled
25 Trials studying Epilepsy
2,923 Patients Enrolled for Epilepsy
Tanya SpruillPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
134 Total Patients Enrolled
2 Trials studying Epilepsy
104 Patients Enrolled for Epilepsy
Daniel Friedman, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
1,500 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have very strong feelings of sadness (score of 20 or higher on a questionnaire).I have been diagnosed with epilepsy for over a year.You have a high score on a depression test called PHQ-9.You have thoughts about hurting yourself or ending your life.I am fluent in either English or Spanish.I am willing to join group calls that will be recorded.I do not have an active psychotic disorder.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: UPLIFT (Using Practice and Learning to Increase Favorable Thoughts)
- Group 2: Arm 2: BOOST (Bringing Out Our Strength Together)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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