<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/NCT02968238</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00041530</org_study_id>
    <secondary_id>CER-1511-33007</secondary_id>
    <nct_id>NCT02968238</nct_id>
  </id_info>
  <brief_title>Tranquil Moments II-CBT vs. Yoga for Worry</brief_title>
  <official_title>Cognitive-behavioral Therapy Versus Yoga for the Treatment of Worry in Anxious Older Adults: A Randomized Preference Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety&#xD;
      is more common that depression, yet research on the nature and treatment of anxiety has&#xD;
      lagged far behind that of depression. The investigators' work has demonstrated that CBT is&#xD;
      superior to enhanced usual care as well as supportive therapy in improving worry, depressive&#xD;
      symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing&#xD;
      treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators'&#xD;
      own work demonstrates that yoga improves sleep. However, no one has conducted a comparative&#xD;
      effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are&#xD;
      very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians&#xD;
      are unable to provide an informed recommendation of one treatment over the other. The&#xD;
      investigators propose a two-stage randomized preference trial comparing 1)&#xD;
      cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older&#xD;
      adults. Participants will be randomized to either the preference group (participants choose&#xD;
      the treatment) or to the random group (participants are randomized to 1 of the 2 treatments).&#xD;
      This study design allows for the calculation of traditional treatment effects (differences in&#xD;
      outcomes between participants randomized to either CBT or yoga), selection effects&#xD;
      (differences in outcomes between participants who choose CBT and those who choose yoga), and&#xD;
      preference effects (differences in outcomes between participants who choose their treatment&#xD;
      and those who are randomized to treatment).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary aim of this study is to compare the effects of CBT and yoga on worry in older&#xD;
      adults (as assessed by the PSWQ-A measured at post-intervention, Week 11). Secondary aims are&#xD;
      to compare the effects of these treatments on anxiety and sleep (as assessed by the PROMIS&#xD;
      anxiety scale and the ISI, respectively, measured at post-intervention, Week 11). Exploratory&#xD;
      aims are to determine participant preference for CBT vs. yoga; examine participant preference&#xD;
      effects on worry, anxiety, sleep, adherence to treatment, and attrition rates; and examine&#xD;
      selection effects on worry, anxiety, sleep, adherence to treatment, and attrition rates. All&#xD;
      analyses will be repeated for measures assessed at Week 37.&#xD;
&#xD;
      The treatment effect for the primary aim will be estimated by comparing mean PSWQ-A scores&#xD;
      between CBT and yoga groups in the random group (N=250, 125 per group) using constrained&#xD;
      mixed-model repeated measures analysis of covariance with an unstructured covariance matrix&#xD;
      to account for the fact that the multiple measurements (at baseline-Week 0,&#xD;
      mid-intervention-Week 6, post-intervention-Week 11) from participants are not independent.&#xD;
      The model will contain terms for baseline psychotropic medication use, gender and race (both&#xD;
      related to depression), and intervention effects that are specific to each follow-up time.&#xD;
      Because this arm of the trial has been randomized, we will constrain the pre-randomization&#xD;
      intervention-specific outcome means to be the same. A contrast will be used to test the&#xD;
      primary hypothesis at the post-intervention (Week 11) time point using a two-sided 0.05&#xD;
      significance level. In the primary analysis, all randomized participants will be included in&#xD;
      their original study group for analysis regardless of the final mode of intervention or the&#xD;
      extent of compliance with the study protocol; that is, the primary analysis will follow an&#xD;
      &quot;intent to treat&quot; philosophy.&#xD;
&#xD;
      As part of the secondary aims, the estimation of selection and preference effects will be&#xD;
      performed with mixed models based on the complete sample using data collected in both&#xD;
      preference and randomized arms of the trial. Therefore, these analyses will be based on a&#xD;
      sample size of 500 individuals. The adjusted means and variance-covariance matrix needed to&#xD;
      compute these effects and their standard error will be estimated from the fitted model. The&#xD;
      standard error associated with the preference and selection effects will be derived using the&#xD;
      delta-method and/or a bootstrapping approach, as needed.&#xD;
&#xD;
      Consistency of intervention effects will be explored within the following baseline subgroups:&#xD;
      1) depressive symptoms from PROMIS measure (none or mild vs. moderate or severe), 2) use of&#xD;
      psychotropic meds (any vs none), 3) age (60-79 vs 80+), 4) gender (female/male), and 5) race&#xD;
      (White vs. other races).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">April 22, 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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Penn State Worry Questionnaire-Abbreviated</measure>
    <time_frame>Week 11</time_frame>
    <description>worry symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PROMIS Anxiety</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia Sleep Index</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>sleep problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn State Worry Questionnaire-Abbreviated</measure>
    <time_frame>Week 6, Week 37</time_frame>
    <description>worry symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS 29</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>29-item self-report measure with 4 items each for the following: physical function, anxiety, depression, fatigue, sleep, social function, pain interference; 1 item for average pain intensity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Depression</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>depressive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Physical Function with Mobility Aid</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>Self-report measure of current capability for physical activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAD-7</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>Self-report symptoms of Generalized Anxiety Disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cornell Medical Services Index</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>measure of medical care utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire</measure>
    <time_frame>Week 11</time_frame>
    <description>self-report measure of satisfaction with treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Working Alliance Inventory, Client and Therapist</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>assesses therapist-patient working alliance; measures are completed by the participant and the therapist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the intervention as assessed by the number of sessions attended</measure>
    <time_frame>Week 11</time_frame>
    <description>adherence to treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition from the intervention as assessed by the number of participants who do not complete study assessments at Week 11 and Week 37</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>attrition from study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FES-I</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>falls self-efficacy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>Week 11, Week 37</time_frame>
    <description>self-report incidence of falls</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Penn State Worry Questionnaire-Abbreviated</measure>
    <time_frame>Week 37</time_frame>
    <description>worry symptoms</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Anxiety</condition>
  <arm_group>
    <arm_group_label>CBT preference arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CBT preference arm consists of participants who are randomized to the preference condition and choose to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga preference arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Yoga preference arm consists of participants who are randomized to the preference condition and choose to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CBT randomized arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>CBT randomized arm consists of participants who are randomized to the random condition and are randomized to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Yoga randomized arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Yoga randomized arm consists of participants who are randomized to the random condition and are randomized to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-behavioral therapy</intervention_name>
    <description>10 weekly sessions of cognitive-behavioral therapy</description>
    <arm_group_label>CBT preference arm</arm_group_label>
    <arm_group_label>CBT randomized arm</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga</intervention_name>
    <description>10 weeks of biweekly yoga sessions (N = 20)</description>
    <arm_group_label>Yoga preference arm</arm_group_label>
    <arm_group_label>Yoga randomized arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 60 years and older&#xD;
&#xD;
          -  Moderate to severe levels of worry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently receiving psychotherapy&#xD;
&#xD;
          -  Currently practicing yoga&#xD;
&#xD;
          -  Active alcohol/substance abuse&#xD;
&#xD;
          -  Dementia&#xD;
&#xD;
          -  Current psychotic symptoms&#xD;
&#xD;
          -  Active suicidal ideation with plan and intent&#xD;
&#xD;
          -  Hearing loss that would prevent a person from participating in telephone/class&#xD;
             sessions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gretchen Brenes, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>May 8, 2020</last_update_submitted>
  <last_update_submitted_qc>May 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/38/NCT02968238/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02968238
org study id: IRB00041530
secondary id: CER-1511-33007
nct id: NCT02968238
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Anxiety disorders are the most prevalent psychiatric disorders. Among older adults, anxiety
      is more common that depression, yet research on the nature and treatment of anxiety has
      lagged far behind that of depression. The investigators' work has demonstrated that CBT is
      superior to enhanced usual care as well as supportive therapy in improving worry, depressive
      symptoms, and sleep, and these improvements are maintained for up to 1 year upon completing
      treatment. Research demonstrates that yoga reduces anxiety symptoms and the investigators'
      own work demonstrates that yoga improves sleep. However, no one has conducted a comparative
      effectiveness trial of CBT and yoga for treating worry in older adults. In fact, there are
      very few comparative effectiveness trials for treating late-life anxiety. Thus, clinicians
      are unable to provide an informed recommendation of one treatment over the other. The
      investigators propose a two-stage randomized preference trial comparing 1)
      cognitive-behavioral therapy with 2) yoga for the treatment of worry in a sample of older
      adults. Participants will be randomized to either the preference group (participants choose
      the treatment) or to the random group (participants are randomized to 1 of the 2 treatments).
      This study design allows for the calculation of traditional treatment effects (differences in
      outcomes between participants randomized to either CBT or yoga), selection effects
      (differences in outcomes between participants who choose CBT and those who choose yoga), and
      preference effects (differences in outcomes between participants who choose their treatment
      and those who are randomized to treatment).
The primary aim of this study is to compare the effects of CBT and yoga on worry in older
      adults (as assessed by the PSWQ-A measured at post-intervention, Week 11). Secondary aims are
      to compare the effects of these treatments on anxiety and sleep (as assessed by the PROMIS
      anxiety scale and the ISI, respectively, measured at post-intervention, Week 11). Exploratory
      aims are to determine participant preference for CBT vs. yoga; examine participant preference
      effects on worry, anxiety, sleep, adherence to treatment, and attrition rates; and examine
      selection effects on worry, anxiety, sleep, adherence to treatment, and attrition rates. All
      analyses will be repeated for measures assessed at Week 37.

      The treatment effect for the primary aim will be estimated by comparing mean PSWQ-A scores
      between CBT and yoga groups in the random group (N=250, 125 per group) using constrained
      mixed-model repeated measures analysis of covariance with an unstructured covariance matrix
      to account for the fact that the multiple measurements (at baseline-Week 0,
      mid-intervention-Week 6, post-intervention-Week 11) from participants are not independent.
      The model will contain terms for baseline psychotropic medication use, gender and race (both
      related to depression), and intervention effects that are specific to each follow-up time.
      Because this arm of the trial has been randomized, we will constrain the pre-randomization
      intervention-specific outcome means to be the same. A contrast will be used to test the
      primary hypothesis at the post-intervention (Week 11) time point using a two-sided 0.05
      significance level. In the primary analysis, all randomized participants will be included in
      their original study group for analysis regardless of the final mode of intervention or the
      extent of compliance with the study protocol; that is, the primary analysis will follow an
      "intent to treat" philosophy.

      As part of the secondary aims, the estimation of selection and preference effects will be
      performed with mixed models based on the complete sample using data collected in both
      preference and randomized arms of the trial. Therefore, these analyses will be based on a
      sample size of 500 individuals. The adjusted means and variance-covariance matrix needed to
      compute these effects and their standard error will be estimated from the fitted model. The
      standard error associated with the preference and selection effects will be derived using the
      delta-method and/or a bootstrapping approach, as needed.

      Consistency of intervention effects will be explored within the following baseline subgroups:
      1) depressive symptoms from PROMIS measure (none or mild vs. moderate or severe), 2) use of
      psychotropic meds (any vs none), 3) age (60-79 vs 80+), 4) gender (female/male), and 5) race
      (White vs. other races).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Care Provider)
measure: Penn State Worry Questionnaire-Abbreviated
time frame: Week 11
description: worry symptoms
measure: PROMIS Anxiety
time frame: Week 11, Week 37
description: anxiety symptoms
measure: Insomnia Sleep Index
time frame: Week 11, Week 37
description: sleep problems
measure: Penn State Worry Questionnaire-Abbreviated
time frame: Week 6, Week 37
description: worry symptoms
measure: PROMIS 29
time frame: Week 11, Week 37
description: 29-item self-report measure with 4 items each for the following: physical function, anxiety, depression, fatigue, sleep, social function, pain interference; 1 item for average pain intensity
measure: PROMIS Depression
time frame: Week 11, Week 37
description: depressive symptoms
measure: PROMIS Physical Function with Mobility Aid
time frame: Week 11, Week 37
description: Self-report measure of current capability for physical activities
measure: GAD-7
time frame: Week 11, Week 37
description: Self-report symptoms of Generalized Anxiety Disorder
measure: Cornell Medical Services Index
time frame: Week 11, Week 37
description: measure of medical care utilization
measure: Client Satisfaction Questionnaire
time frame: Week 11
description: self-report measure of satisfaction with treatment
measure: Working Alliance Inventory, Client and Therapist
time frame: Week 11, Week 37
description: assesses therapist-patient working alliance; measures are completed by the participant and the therapist
measure: Adherence to the intervention as assessed by the number of sessions attended
time frame: Week 11
description: adherence to treatment
measure: Attrition from the intervention as assessed by the number of participants who do not complete study assessments at Week 11 and Week 37
time frame: Week 11, Week 37
description: attrition from study
measure: FES-I
time frame: Week 11, Week 37
description: falls self-efficacy
measure: Falls
time frame: Week 11, Week 37
description: self-report incidence of falls
measure: Penn State Worry Questionnaire-Abbreviated
time frame: Week 37
description: worry symptoms
arm group label: CBT preference arm
arm group type: Active Comparator
description: CBT preference arm consists of participants who are randomized to the preference condition and choose to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.
arm group label: Yoga preference arm
arm group type: Active Comparator
description: Yoga preference arm consists of participants who are randomized to the preference condition and choose to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).
arm group label: CBT randomized arm
arm group type: Active Comparator
description: CBT randomized arm consists of participants who are randomized to the random condition and are randomized to receive cognitive-behavioral therapy (CBT). CBT consists of 10 weeks of weekly treatment.
arm group label: Yoga randomized arm
arm group type: Active Comparator
description: Yoga randomized arm consists of participants who are randomized to the random condition and are randomized to receive yoga. Yoga consists of 10 weeks of bi-weekly treatment (total = 20 treatments).
intervention type: Behavioral
intervention name: Cognitive-behavioral therapy
description: 10 weekly sessions of cognitive-behavioral therapy
arm group label: CBT preference arm
arm group label: CBT randomized arm
other name: CBT
intervention type: Behavioral
intervention name: Yoga
description: 10 weeks of biweekly yoga sessions (N = 20)
arm group label: Yoga preference arm
arm group label: Yoga randomized arm
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gretchen Brenes, PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 