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Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03000725
Enrollment
72
Registered
2016-12-22
Start date
2016-10-31
Completion date
2019-09-30
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

BEHAVIORALUsing 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

BEHAVIORALUsual Care

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

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)12 MonthsThis measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.

Secondary

MeasureTime frameDescription
Quality Of Life in Epilepsy (QOLIE-10)12 MonthsThis measure assesses health-related quality of life for adults with epilepsy.
PROMIS-Global12 MonthsThis 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.

Other

MeasureTime frameDescription
Interpersonal Support Evaluation List (ISEL)12 MonthsThis measure assesses the perceived availability of appraisal, belonging and tangible social support.
Five Facet Mindfulness Questionnaire Description (FFMQ) Short form12 MonthsThis 24-item measure assesses the construct of mindfulness through five component skills: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Ruminative Responses Scale (RRS)12 MonthsThis 22-item scale assesses cognitive responses to depressed mood.
Work Productivity and Activity Impairment Questionnaire (WPAI)12 MonthsThis self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.
Pittsburgh Sleep Quality Index (PSQI)12 MonthsThis 19-item questionnaire assesses sleep quality over the past month.
Epilepsy Stigma Scale12 MonthsThis 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.
Healthcare Utilization12 MonthsThis self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
Perceived Stress Scale (PSS-10)12 MonthsThis 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.
Self-Compassion Scale (SCS)12 MonthsThis measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.
Satisfaction with Life Scale (SWLS)12 MonthsThis 5-item instrument measures global cognitive judgments of satisfaction with one's life.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026