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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03000725
Other study ID # 16-01531
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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