Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Using Practice and Learning to Increase Favorable Thoughts
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
Inclusion Criteria:
- self-identified as Hispanic
- English or Spanish speaking
- diagnosis of epilepsy for at least one year post diagnosis
- willing to participate in 8 one-hour telephone sessions every week for eight weeks.
- willing to be audio-taped
- Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) score >13
Exclusion Criteria:
- Severe depression (CES-D > 37)
- Active suicidal ideation
- Significant cognitive impairment (evident during screening)
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
UPLIFT
USUAL CARE
Arm Description
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL).
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire (PHQ-9)
This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
Secondary Outcome Measures
Quality Of Life in Epilepsy (QOLIE-10)
This measure assesses health-related quality of life for adults with epilepsy.
PROMIS-Global
This 10-item measure was developed by NIH to assess physical, mental and social functioning. It is a generic rather than disease-specific measure of global health.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03000725
Brief Title
Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
Official Title
Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL); it was developed at Emory University with CDC funding.
Detailed Description
The goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression. A 2-arm randomized control trial will be conducted to evaluate the feasibility, acceptability and effects of Project UPLIFT versus usual care (UC) in Hispanic patients with epilepsy.
The specific aim of this study is: To evaluate the feasibility, acceptability and short- and long-term effects of the adapted intervention on depression and other outcomes in 72 English- and Spanish-speaking Hispanic epilepsy patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UPLIFT
Arm Type
Active Comparator
Arm Description
Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy by phone to reduce their depression and improve quality of life (QOL).
Arm Title
USUAL CARE
Arm Type
Active Comparator
Arm Description
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
Intervention Type
Behavioral
Intervention Name(s)
Using Practice and Learning to Increase Favorable Thoughts
Intervention Description
Description of the UPLIFT program: Participants who choose to participate in UPLIFT will complete 8 weekly group sessions via telephone.
Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Quality Of Life in Epilepsy (QOLIE-10)
Description
This measure assesses health-related quality of life for adults with epilepsy.
Time Frame
12 Months
Title
PROMIS-Global
Description
This 10-item measure was developed by NIH to assess physical, mental and social functioning. It is a generic rather than disease-specific measure of global health.
Time Frame
12 Months
Other Pre-specified Outcome Measures:
Title
Work Productivity and Activity Impairment Questionnaire (WPAI)
Description
This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.
Time Frame
12 Months
Title
Self-Compassion Scale (SCS)
Description
This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.
Time Frame
12 Months
Title
Satisfaction with Life Scale (SWLS)
Description
This 5-item instrument measures global cognitive judgments of satisfaction with one's life.
Time Frame
12 Months
Title
Interpersonal Support Evaluation List (ISEL)
Description
This measure assesses the perceived availability of appraisal, belonging and tangible social support.
Time Frame
12 Months
Title
Five Facet Mindfulness Questionnaire Description (FFMQ) Short form
Description
This 24-item measure assesses the construct of mindfulness through five component skills: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Time Frame
12 Months
Title
Ruminative Responses Scale (RRS)
Description
This 22-item scale assesses cognitive responses to depressed mood.
Time Frame
12 Months
Title
Perceived Stress Scale (PSS-10)
Description
This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.
Time Frame
12 Months
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
This 19-item questionnaire assesses sleep quality over the past month.
Time Frame
12 Months
Title
Epilepsy Stigma Scale
Description
This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.
Time Frame
12 Months
Title
Healthcare Utilization
Description
This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
self-identified as Hispanic
English or Spanish speaking
diagnosis of epilepsy for at least one year post diagnosis
willing to participate in 8 one-hour telephone sessions every week for eight weeks.
willing to be audio-taped
Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale (CES-D) score >13
Exclusion Criteria:
Severe depression (CES-D > 37)
Active suicidal ideation
Significant cognitive impairment (evident during screening)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanya Spruill
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adapting Project UPLIFT for Hispanic Patients With Epilepsy II
We'll reach out to this number within 24 hrs