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Completed

NCT Number: NCT03000725

Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Using Practice and Learning to Increase Favorable Thoughts

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

Behavioral

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

Primary outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 12 Months

    This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.

Secondary outcomes

  1. Quality Of Life in Epilepsy (QOLIE-10)

    Time frame: 12 Months

    This measure assesses health-related quality of life for adults with epilepsy.

  2. PROMIS-Global

    Time frame: 12 Months

    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.

Other outcomes

  1. Work Productivity and Activity Impairment Questionnaire (WPAI)

    Time frame: 12 Months

    This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.

  2. Self-Compassion Scale (SCS)

    Time frame: 12 Months

    This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.

  3. Satisfaction with Life Scale (SWLS)

    Time frame: 12 Months

    This 5-item instrument measures global cognitive judgments of satisfaction with one's life.

  4. Interpersonal Support Evaluation List (ISEL)

    Time frame: 12 Months

    This measure assesses the perceived availability of appraisal, belonging and tangible social support.

  5. Five Facet Mindfulness Questionnaire Description (FFMQ) Short form

    Time frame: 12 Months

    This 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.

  6. Ruminative Responses Scale (RRS)

    Time frame: 12 Months

    This 22-item scale assesses cognitive responses to depressed mood.

  7. Perceived Stress Scale (PSS-10)

    Time frame: 12 Months

    This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.

  8. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 12 Months

    This 19-item questionnaire assesses sleep quality over the past month.

  9. Epilepsy Stigma Scale

    Time frame: 12 Months

    This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.

  10. Healthcare Utilization

    Time frame: 12 Months

    This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2016
Registry last updated
May 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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