Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Using Practice and Learning to Increase Favorable Thoughts; Behavioral: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: UPLIFT; 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).	Behavioral: Using Practice and Learning to Increase Favorable Thoughts; 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
Active Comparator: USUAL CARE; Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.	Behavioral: Usual Care; Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire (PHQ-9)	This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality Of Life in Epilepsy (QOLIE-10)	This measure assesses health-related quality of life for adults with epilepsy.	12 Months
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.	12 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work Productivity and Activity Impairment Questionnaire (WPAI)	This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.	12 Months
Self-Compassion Scale (SCS)	This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.	12 Months
Satisfaction with Life Scale (SWLS)	This 5-item instrument measures global cognitive judgments of satisfaction with one's life.	12 Months
Interpersonal Support Evaluation List (ISEL)	This measure assesses the perceived availability of appraisal, belonging and tangible social support.	12 Months
Five Facet Mindfulness Questionnaire Description (FFMQ) Short form	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.	12 Months
Ruminative Responses Scale (RRS)	This 22-item scale assesses cognitive responses to depressed mood.	12 Months
Perceived Stress Scale (PSS-10)	This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.	12 Months
Pittsburgh Sleep Quality Index (PSQI)	This 19-item questionnaire assesses sleep quality over the past month.	12 Months
Epilepsy Stigma Scale	This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.	12 Months
Healthcare Utilization	This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).	12 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Tanya Spruill, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 20, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 16-01531

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No