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Clinical Trials/NCT03000725
NCT03000725CompletedNot Applicable

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

NYU Langone Health1 site in 1 country72 target enrollmentStarted: October 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
72
Locations
1
Primary Endpoint
Patient Health Questionnaire (PHQ-9)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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)

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-9)

Time Frame: 12 Months

This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.

Secondary Outcomes

  • Quality Of Life in Epilepsy (QOLIE-10)(12 Months)
  • PROMIS-Global(12 Months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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