Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

Not Applicable

Completed

• Conditions: Epilepsy
• Interventions: Behavioral: Using Practice and Learning to Increase Favorable Thoughts; Behavioral: Usual Care

• Registration Number: NCT03000725
• Lead Sponsor: NYU Langone Health

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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-12-20
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-22
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Read More

Exclusion Criteria

• Severe depression (CES-D > 37)
• Active suicidal ideation
• Significant cognitive impairment (evident during screening)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UPLIFT	Using Practice and Learning to Increase Favorable Thoughts	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).
USUAL CARE	Usual Care	Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Quality Of Life in Epilepsy (QOLIE-10)	12 Months	This measure assesses health-related quality of life for adults with epilepsy.
PROMIS-Global	12 Months	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States