Adapting Project UPLIFT for Hispanic Patients With Epilepsy II

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000725
• Other study ID #: 16-01531
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2019

Study information

• Verified date: May 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Work Productivity and Activity Impairment Questionnaire (WPAI)	This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.	12 Months
Other	Self-Compassion Scale (SCS)	This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.	12 Months
Other	Satisfaction with Life Scale (SWLS)	This 5-item instrument measures global cognitive judgments of satisfaction with one's life.	12 Months
Other	Interpersonal Support Evaluation List (ISEL)	This measure assesses the perceived availability of appraisal, belonging and tangible social support.	12 Months
Other	Five Facet Mindfulness Questionnaire Description (FFMQ) Short form	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.	12 Months
Other	Ruminative Responses Scale (RRS)	This 22-item scale assesses cognitive responses to depressed mood.	12 Months
Other	Perceived Stress Scale (PSS-10)	This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.	12 Months
Other	Pittsburgh Sleep Quality Index (PSQI)	This 19-item questionnaire assesses sleep quality over the past month.	12 Months
Other	Epilepsy Stigma Scale	This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.	12 Months
Other	Healthcare Utilization	This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).	12 Months
Primary	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	Quality Of Life in Epilepsy (QOLIE-10)	This measure assesses health-related quality of life for adults with epilepsy.	12 Months
Secondary	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