<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000725</url>
  </required_header>
  <id_info>
    <org_study_id>16-01531</org_study_id>
    <nct_id>NCT03000725</nct_id>
  </id_info>
  <brief_title>Adapting Project UPLIFT for Hispanic Patients With Epilepsy II</brief_title>
  <official_title>Adapting Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is for Hispanic Patients With Epilepsy II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and&#xD;
      depression. Project UPLIFT (Using Practice and Learning to Increase Favorable Thoughts) is a&#xD;
      home-based intervention that teaches cognitive and mindfulness skills to people with epilepsy&#xD;
      by phone to reduce their depression and improve quality of life (QOL); it was developed at&#xD;
      Emory University with CDC funding. The purpose of this study is to adapt Project UPLIFT for&#xD;
      Hispanic adults with epilepsy and depression. Project UPLIFT (Using Practice and Learning to&#xD;
      Increase Favorable Thoughts) is a home-based intervention that teaches cognitive and&#xD;
      mindfulness skills to people with epilepsy by phone to reduce their depression and improve&#xD;
      quality of life (QOL); it was developed at Emory University with CDC funding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to adapt Project UPLIFT for Hispanic adults with epilepsy and&#xD;
      depression. A 2-arm randomized control trial will be conducted to evaluate the feasibility,&#xD;
      acceptability and effects of Project UPLIFT versus usual care (UC) in Hispanic patients with&#xD;
      epilepsy.&#xD;
&#xD;
      The specific aim of this study is: To evaluate the feasibility, acceptability and short- and&#xD;
      long-term effects of the adapted intervention on depression and other outcomes in 72 English-&#xD;
      and Spanish-speaking Hispanic epilepsy patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>12 Months</time_frame>
    <description>This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality Of Life in Epilepsy (QOLIE-10)</measure>
    <time_frame>12 Months</time_frame>
    <description>This measure assesses health-related quality of life for adults with epilepsy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS-Global</measure>
    <time_frame>12 Months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Work Productivity and Activity Impairment Questionnaire (WPAI)</measure>
    <time_frame>12 Months</time_frame>
    <description>This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Compassion Scale (SCS)</measure>
    <time_frame>12 Months</time_frame>
    <description>This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Satisfaction with Life Scale (SWLS)</measure>
    <time_frame>12 Months</time_frame>
    <description>This 5-item instrument measures global cognitive judgments of satisfaction with one's life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Interpersonal Support Evaluation List (ISEL)</measure>
    <time_frame>12 Months</time_frame>
    <description>This measure assesses the perceived availability of appraisal, belonging and tangible social support.</description>
  </other_outcome>
  <other_outcome>
    <measure>Five Facet Mindfulness Questionnaire Description (FFMQ) Short form</measure>
    <time_frame>12 Months</time_frame>
    <description>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.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ruminative Responses Scale (RRS)</measure>
    <time_frame>12 Months</time_frame>
    <description>This 22-item scale assesses cognitive responses to depressed mood.</description>
  </other_outcome>
  <other_outcome>
    <measure>Perceived Stress Scale (PSS-10)</measure>
    <time_frame>12 Months</time_frame>
    <description>This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.</description>
  </other_outcome>
  <other_outcome>
    <measure>Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>12 Months</time_frame>
    <description>This 19-item questionnaire assesses sleep quality over the past month.</description>
  </other_outcome>
  <other_outcome>
    <measure>Epilepsy Stigma Scale</measure>
    <time_frame>12 Months</time_frame>
    <description>This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare Utilization</measure>
    <time_frame>12 Months</time_frame>
    <description>This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>UPLIFT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>USUAL CARE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Using Practice and Learning to Increase Favorable Thoughts</intervention_name>
    <description>Description of the UPLIFT program: Participants who choose to participate in UPLIFT will complete 8 weekly group sessions via telephone.&#xD;
Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping &amp; Relaxing Session 4: Attention &amp; Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure &amp; the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks</description>
    <arm_group_label>UPLIFT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.</description>
    <arm_group_label>USUAL CARE</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  self-identified as Hispanic&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  diagnosis of epilepsy for at least one year post diagnosis&#xD;
&#xD;
          -  willing to participate in 8 one-hour telephone sessions every week for eight weeks.&#xD;
&#xD;
          -  willing to be audio-taped&#xD;
&#xD;
          -  Elevated depressive symptoms (Center for Epidemiological Studies Depression Scale&#xD;
             (CES-D) score &gt;13&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe depression (CES-D &gt; 37)&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Significant cognitive impairment (evident during screening)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanya Spruill</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New York University School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000725
org study id: 16-01531
nct id: NCT03000725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Patient Health Questionnaire (PHQ-9)
time frame: 12 Months
description: This measure assesses depressive symptoms in the past two weeks based on DSM-IV diagnostic criteria for major depression.
measure: Quality Of Life in Epilepsy (QOLIE-10)
time frame: 12 Months
description: This measure assesses health-related quality of life for adults with epilepsy.
measure: PROMIS-Global
time frame: 12 Months
description: 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.
measure: Work Productivity and Activity Impairment Questionnaire (WPAI)
time frame: 12 Months
description: This self-report measure assesses the impact of disease on productivity and work productivity loss due to general health or a specified health problem.
measure: Self-Compassion Scale (SCS)
time frame: 12 Months
description: This measure assesses trait levels of self-compassion, including the thoughts, emotions and behaviors associated with the various components of self-compassion.
measure: Satisfaction with Life Scale (SWLS)
time frame: 12 Months
description: This 5-item instrument measures global cognitive judgments of satisfaction with one's life.
measure: Interpersonal Support Evaluation List (ISEL)
time frame: 12 Months
description: This measure assesses the perceived availability of appraisal, belonging and tangible social support.
measure: Five Facet Mindfulness Questionnaire Description (FFMQ) Short form
time frame: 12 Months
description: 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.
measure: Ruminative Responses Scale (RRS)
time frame: 12 Months
description: This 22-item scale assesses cognitive responses to depressed mood.
measure: Perceived Stress Scale (PSS-10)
time frame: 12 Months
description: This 10-item measure assesses the degree to which situations in one's life are appraised as stressful or overwhelming.
measure: Pittsburgh Sleep Quality Index (PSQI)
time frame: 12 Months
description: This 19-item questionnaire assesses sleep quality over the past month.
measure: Epilepsy Stigma Scale
time frame: 12 Months
description: This 10-item measure assesses the degree to which a person believes that epilepsy is perceived as negative and interferes with relationships with others.
measure: Healthcare Utilization
time frame: 12 Months
description: This self-report questionnaire assesses the use of healthcare services (e.g., clinic visits ED visits, etc).
arm group label: UPLIFT
arm group type: Active Comparator
description: 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).
arm group label: USUAL CARE
arm group type: Active Comparator
description: Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
intervention type: Behavioral
intervention name: Using Practice and Learning to Increase Favorable Thoughts
description: 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
arm group label: UPLIFT
intervention type: Behavioral
intervention name: Usual Care
description: Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
arm group label: USUAL CARE
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tanya Spruill
role: Principal Investigator
affiliation: NYU Langone Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy