Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

Study Overview
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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.

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

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Using Practice and Learning to Increase Favorable Thoughts
* Behavioral: Usual Care


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UPLIFT<br>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<br>* 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<br>|
| Active Comparator: USUAL CARE<br>Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred. | Behavioral: Usual Care<br>* Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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