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Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03000725
Recruitment Status : Active, not recruiting
First Posted : December 22, 2016
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Behavioral: Using Practice and Learning to Increase Favorable Thoughts Behavioral: Usual Care Not Applicable

Detailed Description:

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 goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and depression.

The specific aim of this study is:

Aim 1: 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II
Study Start Date : September 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.




Primary Outcome Measures :
  1. Quality Of Life in Epilepsy (QOLIE-10) [ Time Frame: 12 Months ]
    This is a survey of health related quality of life for adults (18 years or older) with epilepsy.

  2. Morisky Medication Adherence Scale (MMAS 8) [ Time Frame: 12 Months ]
    A self-reported 4-item scale to assess medication adherence.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000725


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Tanya Spruill NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03000725     History of Changes
Other Study ID Numbers: 16-01531
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases