<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/NCT01702220</url>
  </required_header>
  <id_info>
    <org_study_id>H30928</org_study_id>
    <nct_id>NCT01702220</nct_id>
  </id_info>
  <brief_title>Calmer Life: Testing the Effectiveness of a Treatment for Anxiety</brief_title>
  <official_title>Calmer Life: A Randomized Controlled Trial of a Participant-Centered Treatment for Anxiety in Low-Income, Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Retirement Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Archstone Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goals of the proposed research study are to: (1) examine quantitative outcomes in&#xD;
      a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community&#xD;
      Care, an information and referral intervention that represents care in a real-world&#xD;
      community-service environment, and (2) evaluate implementation feasibility, which includes&#xD;
      training community providers; examining program reach, engagement, acceptability, and&#xD;
      barriers-facilitators; and preparing practical tools for replicating the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in&#xD;
      academic and primary care settings, but minorities are significantly underrepresented in&#xD;
      clinical trials, and standard CBT poorly addresses the needs of low-income minority older&#xD;
      adults in underserved communities. More attention needs to be given to service delivery of&#xD;
      anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored,&#xD;
      participant-centered research study that offers a skills-based intervention for late-life&#xD;
      anxiety and includes other elements of care to meet the needs of underserved, minority older&#xD;
      adults, including the option to integrate religion/spirituality (R/S), flexible delivery&#xD;
      modes, and modular treatment format.&#xD;
&#xD;
      Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will&#xD;
      be provided by behavioral health clinicians recruited from partner organizations, psychology&#xD;
      trainees, and other research staff over 3 months. Assessments will occur at baseline and 3&#xD;
      months.&#xD;
&#xD;
      Participants in the CL condition can choose up to 12 individual skill sessions, and will be&#xD;
      recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S,&#xD;
      an R/S assessment occurs during session 2 to help the provider understand the participant's&#xD;
      beliefs and practices. R/S can be integrated into any of the skills learned during the&#xD;
      intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.&#xD;
&#xD;
      Participants in the ECC condition will receive brief biweekly check in calls to provide&#xD;
      information about community resources (including mental health), offer emotional support, and&#xD;
      assess symptom severity and need for crisis intervention. Emergency procedures will be&#xD;
      followed in crisis situations. After 3 months of ECC is completed, participants in the ECC&#xD;
      group will be offered the CL intervention.&#xD;
&#xD;
      Outcome measures will be administered for participants in both groups at baseline, 1 month,&#xD;
      and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Geriatric Anxiety Inventory</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Penn State Worry Questionnaire (PSWQ-A)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder-7</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Severity Index</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Late-Life Functional Disability Index</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health Survey</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief RCOPE</measure>
    <time_frame>3 months</time_frame>
    <description>Religious coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health services use</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of psychotropic medication</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Multidimensional Measure of Religiousness and Spirituality</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Life Scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Depression Scale</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <condition>Anxiety Disorder NOS</condition>
  <arm_group>
    <arm_group_label>CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Community Care (ECC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT</intervention_name>
    <description>6-12 sessions of CBT in person or over the phone</description>
    <arm_group_label>CBT</arm_group_label>
    <other_name>Cognitive Behavior Treatment, Cognitive Behavior Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ECC</intervention_name>
    <description>6 biweekly sessions of ECC over the telephone</description>
    <arm_group_label>Enhanced Community Care (ECC)</arm_group_label>
    <other_name>Enhanced Community Care</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 50 and older&#xD;
&#xD;
          -  Principal or Co-principal diagnosis of GAD or ADNOS&#xD;
&#xD;
          -  Must speak English&#xD;
&#xD;
          -  Must have a health care or social service provider and provide written authorization&#xD;
             to research team to communicate with their health-care or social service provider&#xD;
&#xD;
          -  Must live, work, worship, attend community functions, and/or receive health care in&#xD;
             target geographic areas&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active suicidal intent&#xD;
&#xD;
          -  Current psychosis&#xD;
&#xD;
          -  Mania or substance abuse within the last month&#xD;
&#xD;
          -  Cognitive impairment according to a Mini Cog screener score of 3 or lower&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melinda A Stanley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Houston Center for Quality of Care and Utilization Studies</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>January 11, 2016</last_update_submitted>
  <last_update_submitted_qc>January 11, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Melinda Stanley</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Generalized Anxiety Disorder</keyword>
  <keyword>Geriatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT01702220
org study id: H30928
nct id: NCT01702220
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The overall goals of the proposed research study are to: (1) examine quantitative outcomes in
      a well-conducted randomized clinical trial of Calmer Life, relative to Enhanced Community
      Care, an information and referral intervention that represents care in a real-world
      community-service environment, and (2) evaluate implementation feasibility, which includes
      training community providers; examining program reach, engagement, acceptability, and
      barriers-facilitators; and preparing practical tools for replicating the program.
Cognitive behavioral treatment (CBT) produces positive outcomes for late-life worry/GAD in
      academic and primary care settings, but minorities are significantly underrepresented in
      clinical trials, and standard CBT poorly addresses the needs of low-income minority older
      adults in underserved communities. More attention needs to be given to service delivery of
      anxiety treatments for underserved older adults. Calmer Life (CL) is a culturally tailored,
      participant-centered research study that offers a skills-based intervention for late-life
      anxiety and includes other elements of care to meet the needs of underserved, minority older
      adults, including the option to integrate religion/spirituality (R/S), flexible delivery
      modes, and modular treatment format.

      Participants will be randomly assigned to CL or Enhanced Community Care(ECC). CL and ECC will
      be provided by behavioral health clinicians recruited from partner organizations, psychology
      trainees, and other research staff over 3 months. Assessments will occur at baseline and 3
      months.

      Participants in the CL condition can choose up to 12 individual skill sessions, and will be
      recommended to complete a minimum of 6 sessions. If participants desire to incorporate R/S,
      an R/S assessment occurs during session 2 to help the provider understand the participant's
      beliefs and practices. R/S can be integrated into any of the skills learned during the
      intervention (e.g., deep breathing, self-statements, sleep management) or omitted entirely.

      Participants in the ECC condition will receive brief biweekly check in calls to provide
      information about community resources (including mental health), offer emotional support, and
      assess symptom severity and need for crisis intervention. Emergency procedures will be
      followed in crisis situations. After 3 months of ECC is completed, participants in the ECC
      group will be offered the CL intervention.

      Outcome measures will be administered for participants in both groups at baseline, 1 month,
      and 3 months. Participants in ECC will complete measures at 6 months after completion of CL.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Geriatric Anxiety Inventory
time frame: 3 months
measure: Penn State Worry Questionnaire (PSWQ-A)
time frame: 3 months
measure: Generalized Anxiety Disorder-7
time frame: 3 months
measure: Patient Health Questionnaire-9
time frame: 3 months
measure: Insomnia Severity Index
time frame: 3 months
measure: Late-Life Functional Disability Index
time frame: 3 months
measure: SF-12 Health Survey
time frame: 3 months
measure: Client Satisfaction Questionnaire
time frame: 3 months
measure: Brief RCOPE
time frame: 3 months
description: Religious coping
measure: Health services use
time frame: 3 months
measure: Use of psychotropic medication
time frame: 3 months
measure: Brief Multidimensional Measure of Religiousness and Spirituality
time frame: 3 months
measure: Satisfaction with Life Scale
time frame: 3 months
measure: Geriatric Depression Scale
time frame: 3 months
arm group label: CBT
arm group type: Experimental
arm group label: Enhanced Community Care (ECC)
arm group type: Active Comparator
intervention type: Behavioral
intervention name: CBT
description: 6-12 sessions of CBT in person or over the phone
arm group label: CBT
other name: Cognitive Behavior Treatment, Cognitive Behavior Therapy
intervention type: Other
intervention name: ECC
description: 6 biweekly sessions of ECC over the telephone
arm group label: Enhanced Community Care (ECC)
other name: Enhanced Community Care
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
last name: Melinda A Stanley, PhD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Melinda Stanley
investigator title: Professor
mesh term: Anxiety Disorders