Clinical trial NCT03000725: 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
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 12 Months
Secondary outcomes:
measure: Quality Of Life in Epilepsy (QOLIE-10)
timeFrame: 12 Months
measure: PROMIS-Global
timeFrame: 12 Months
Other outcomes:
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: 12 Months
measure: Self-Compassion Scale (SCS)
timeFrame: 12 Months
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 12 Months
measure: Interpersonal Support Evaluation List (ISEL)
timeFrame: 12 Months
measure: Five Facet Mindfulness Questionnaire Description (FFMQ) Short form
timeFrame: 12 Months
measure: Ruminative Responses Scale (RRS)
timeFrame: 12 Months
measure: Perceived Stress Scale (PSS-10)
timeFrame: 12 Months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 12 Months
measure: Epilepsy Stigma Scale
timeFrame: 12 Months
measure: Healthcare Utilization
timeFrame: 12 Months
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tanya Spruill
role: PRINCIPAL_INVESTIGATOR
References: