Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

NCT ID: NCT03000725

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Using Practice and Learning to Increase Favorable Thoughts

Intervention Type BEHAVIORAL

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

USUAL CARE

Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

Interventions

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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

Intervention Type BEHAVIORAL

Usual Care

Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanya Spruill

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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16-01531

Identifier Type: -

Identifier Source: org_study_id

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