xml: <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/NCT05980130</url>
    </required_header>
    <id_info>
      <org_study_id>23.0150</org_study_id>
      <nct_id>NCT05980130</nct_id>
    </id_info>
    <brief_title>Can Rumination-Focused Cognitive Behavioral Therapy Reduce the Risk of Cardio-vascular Disease?</brief_title>
    <acronym>RFCBT-I</acronym>
    <official_title>RFCBT I - Proof of Concept Study/Single Subject Design</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Louisville</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Louisville</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>
        Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease.&#xD;
        However, a less known factor that increases the risk of heart disease is depression. In&#xD;
        addition, heart disease can also make depression worse. Almost half of American adults have&#xD;
        some form of heart disease. Patients with low income are at an even greater risk. The&#xD;
        circular relation between depression and heart disease raises the question of whether or not&#xD;
        there are factors that lead to both. Attacking a factor that affects both depression and&#xD;
        heart disease could help prevent them both. One such factor is rumination which is when&#xD;
        someone tends to have repeated negative thoughts that loop without end. This loop in turn&#xD;
        tears and wears down the body over time, making the person be at risk for heart disease and&#xD;
        depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets&#xD;
        rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT&#xD;
        helps to reduce or stop the loop that leads to depression, this project will further look at&#xD;
        the effect of RFCBT on measures of heart health persons with low income.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives Objective #1: Determine whether RFCBT will impact blood pressure as a biomarker of&#xD;
        cardiovascular health. The investigators hypothesize that RFCBT will lead to an improvement&#xD;
        in blood pressure.&#xD;
  &#xD;
        Objective #2: Determine whether RFCBT will impact stress biomarkers of cardiovascular health.&#xD;
        The investigators hypothesize that RF-CBT will lead to an improvement of salivary cortisol.&#xD;
  &#xD;
        Objective #3: Determine whether RFCBT will impact inflammatory biomarkers of cardiovascular&#xD;
        health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary&#xD;
        C-Reactive Protein (h-CRP), interleukin (IL-6), and tumor necrosis factor-alpha (TNF-α).&#xD;
  &#xD;
        Objective #4: Determine the acceptability of RFCBT for individuals with low income. While the&#xD;
        investigators cannot predict the themes that will be generated, the information will have&#xD;
        implications for the use of RFCBT with individuals with low income.&#xD;
  &#xD;
        Study Design/Methodology The investigators will use a multiple baseline design - a type of&#xD;
        Single Case Experimental Design (SCED) and collect survey, interview, and biological (blood&#xD;
        pressure &amp; saliva) data. Because of the study design, all participants will receive&#xD;
        Rumination-Focused Cognitive Behavioral Training (RFCBT); the study is not blinded, and no&#xD;
        non-intervention control group is necessary. As participants will be selected non-randomly,&#xD;
        they will be randomly assigned to a group or in other words after how many weeks of baseline&#xD;
        phase they will perceive RFCBT using the random number generator in the statistics package R.&#xD;
        That is, 1/3rd of the participants will participate in 5 baseline waves of data collection,&#xD;
        each one week apart, before starting RFCBT, another 1/3rd of participants will participate in&#xD;
        6 baseline waves before starting RFCBT, and the final 1/3rd of participants will participate&#xD;
        in 6 baseline waves before starting RFCBT. Thus, all participants will participate in 5 to 7&#xD;
        weekly baseline waves. Next, each participant will participate with their trainer in up to 18&#xD;
        50-minute meetings of RFCBT. In this time, each participant will participate in 6 to 9 waves&#xD;
        of training data collection (one wave of data collection every 2 RFCBT meetings). After&#xD;
        completion of the training, each participant will be followed for another 10 weeks during&#xD;
        which they participate in 5 waves of follow-up data collection (one wave of data collection&#xD;
        every 2 weeks). Thus, each participant participates in 28 to 36 weeks in the study and takes&#xD;
        part in 16 to 21 waves of data collection.&#xD;
  &#xD;
        The investigators plan to recruit 27 adults with low income who have an elevated Response&#xD;
        Style Questionnaire (RSQ)-Brooding score (&gt;= 11), Patient Health Questionnaire (PHQ)-9 score&#xD;
        (10-20), and blood pressure (systolic blood pressure [SBP]/ diastolic blood pressure [DBP]:&#xD;
        &gt;= 120 and/or 80) - that Have A Heart Clinic personnel administers regularly - and speak&#xD;
        fluent English. There are no other exclusion criteria including any medical or psychological&#xD;
        treatment. Patients who fulfill the above listed inclusion criteria are referred by Have A&#xD;
        Heart Clinic personnel to the research team.&#xD;
  &#xD;
        At each wave of data collection, the investigators will administer all the surveys listed in&#xD;
        this report. All questions will be administered at each wave except for the questions about&#xD;
        demographic information which will be asked during Baseline-1 only.&#xD;
  &#xD;
        To measure blood pressure, the investigators will use an oscillometric measurement device. To&#xD;
        do so, a blood pressure cuff will be placed about an inch above the elbow crease. For&#xD;
        reliability purposes, blood pressure will be measured three-times with about 1 minute time&#xD;
        between the measures.&#xD;
  &#xD;
        To measure cortisol, h-CRP, IL-6, and TNF-α levels in saliva, participants will also be asked&#xD;
        to provide saliva samples. Participants will be asked to avoid eating food or drinking&#xD;
        caffeine for 3 hours prior to the saliva data collection in order to prepare for the saliva&#xD;
        testing.&#xD;
  &#xD;
        Once after the participants finish the RFCBT, they will be invited to take part in a&#xD;
        semi-structured interview to explore their experiences in and acceptability of the training.&#xD;
        The investigators intend to do these interviews with all participants who begin RFCBT (i.e.,&#xD;
        defined as completing at least one 50-minute meeting with their trainer), including those who&#xD;
        drop out of the training, in-person, by phone, or a secure video platform.&#xD;
  &#xD;
        The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In&#xD;
        general, a participant and their trainer will identify when the participant ruminates in an&#xD;
        unhelpful manner, what triggers the rumination, what function the rumination fulfills for the&#xD;
        participant, and how the participant already does to stop ruminating. Building on this&#xD;
        knowledge both together will change the environment to reduce the likelihood of the&#xD;
        participant to ruminate, use consciously strategies to stop rumination when it occurs, and&#xD;
        replace rumination by more helpful strategies. In the proposed single subject study, the&#xD;
        participant and the trainer will meet in person or using a UofL approved video platform up to&#xD;
        18 times for 50-minutes.&#xD;
  &#xD;
        Plan for Analysis of Results Following the best practice guidelines of the What Works&#xD;
        Clearinghouse Standards for SCEDs, the investigators will examine consistency, intervention&#xD;
        effect, immediacy, and auto-correlations for rumination, depressive symptoms, blood pressure,&#xD;
        cortisol, h-CRP, IL-6, and TNF-α. The investigators will use Bayesian unknown changepoint&#xD;
        models to estimate the parameters and model the treatment effect. A mixed effects model will&#xD;
        be used to model the hierarchical structure of the data. The dependent variables are&#xD;
        rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The&#xD;
        independent variable is phase. Bayesian estimation will be used to address the small sample&#xD;
        nature of the data. For these statistical analyses the investigators will use R and &quot;Just&#xD;
        Another Gibbs Sampler&quot; (JAGS). The investigators will conduct semi-structured interviews and&#xD;
        analyze data using thematic analysis to generate themes associated with the data. The&#xD;
        statistical program Dedoose will be utilized to facilitate this process.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2026</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single subject design</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>This is a Single subject design study. Thus, as all participants receive the intervention, there is no masking possible.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>Baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>1 week after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>2 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>3 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>4 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>5 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>6 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>7 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>9 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>11 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>13 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>15 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>17 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>19 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>21 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>23 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>25 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>27 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>29 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>31 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response Style Questionnaire</measure>
      <time_frame>33 weeks after baseline 1</time_frame>
      <description>sadness rumination, Score range: 5-20, higher score = more rumination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>Baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>1 week after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>2 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>3 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>4 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>5 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>6 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>7 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>9 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>11 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>13 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>15 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>17 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>19 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>21 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>23 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>25 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>27 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>29 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>31 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire-9</measure>
      <time_frame>33 weeks after baseline 1</time_frame>
      <description>depressive symptoms, Score range: 0-27, higher score = more depressive symptoms</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>Baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>1 week after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>2 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>3 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>4 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>5 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>6 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>7 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>9 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>11 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>13 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>15 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>17 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>19 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>21 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>23 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>25 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>27 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>29 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>31 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>systolic blood pressure measures</measure>
      <time_frame>33 weeks after baseline 1</time_frame>
      <description>systolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>Baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>1 week after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>2 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>3 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>4 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>5 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>6 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>7 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>9 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>11 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>13 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>15 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>17 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>19 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>21 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>23 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>25 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>27 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>29 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>31 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <primary_outcome>
      <measure>diastolic blood pressure measures</measure>
      <time_frame>33 weeks after baseline 1</time_frame>
      <description>diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">9</enrollment>
    <condition>Rumination</condition>
    <condition>Depressive Symptoms</condition>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>RFCBT</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Rumination-Focused Cognitive Behavior Therapy</intervention_name>
      <description>The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their therapist will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the therapist will meet in person or using a UofL approved video platform up to 18 times for 50-minutes.</description>
      <arm_group_label>RFCBT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  RSQ-Brooding score: &gt;= 11&#xD;
  &#xD;
            -  PHQ-9 score: 10-20&#xD;
  &#xD;
            -  SBP: &gt;= 120 and/or DBP: &gt;= 80)&#xD;
  &#xD;
            -  fluent in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  None besides the described inclusion criteria&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Patrick Possel, Dr.rer.soc.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Louisville</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Patrick Possel, Dr.rer.soc.</last_name>
      <phone>502-852-0623</phone>
      <email>patrick.possel@louisville.edu</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Louisville</investigator_affiliation>
      <investigator_full_name>Patrick Possel</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>rumination</keyword>
    <keyword>depressive symptoms</keyword>
    <keyword>blood pressure</keyword>
    <keyword>rumination-focused cognitive behavioral therapy</keyword>
    <keyword>Proof of Concept Study</keyword>
    <keyword>Single subject design</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rumination Syndrome</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Feeding and Eating Disorders of Childhood</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980130
  org study id: 23.0150
  nct id: NCT05980130
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Many people know that a poor diet, exercise, smoking, and alcohol use cause heart disease.
        However, a less known factor that increases the risk of heart disease is depression. In
        addition, heart disease can also make depression worse. Almost half of American adults have
        some form of heart disease. Patients with low income are at an even greater risk. The
        circular relation between depression and heart disease raises the question of whether or not
        there are factors that lead to both. Attacking a factor that affects both depression and
        heart disease could help prevent them both. One such factor is rumination which is when
        someone tends to have repeated negative thoughts that loop without end. This loop in turn
        tears and wears down the body over time, making the person be at risk for heart disease and
        depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets
        rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT
        helps to reduce or stop the loop that leads to depression, this project will further look at
        the effect of RFCBT on measures of heart health persons with low income.
  Objectives Objective #1: Determine whether RFCBT will impact blood pressure as a biomarker of
        cardiovascular health. The investigators hypothesize that RFCBT will lead to an improvement
        in blood pressure.
  
        Objective #2: Determine whether RFCBT will impact stress biomarkers of cardiovascular health.
        The investigators hypothesize that RF-CBT will lead to an improvement of salivary cortisol.
  
        Objective #3: Determine whether RFCBT will impact inflammatory biomarkers of cardiovascular
        health. The investigators hypothesize that RF-CBT will lead to an improvement of salivary
        C-Reactive Protein (h-CRP), interleukin (IL-6), and tumor necrosis factor-alpha (TNF-α).
  
        Objective #4: Determine the acceptability of RFCBT for individuals with low income. While the
        investigators cannot predict the themes that will be generated, the information will have
        implications for the use of RFCBT with individuals with low income.
  
        Study Design/Methodology The investigators will use a multiple baseline design - a type of
        Single Case Experimental Design (SCED) and collect survey, interview, and biological (blood
        pressure & saliva) data. Because of the study design, all participants will receive
        Rumination-Focused Cognitive Behavioral Training (RFCBT); the study is not blinded, and no
        non-intervention control group is necessary. As participants will be selected non-randomly,
        they will be randomly assigned to a group or in other words after how many weeks of baseline
        phase they will perceive RFCBT using the random number generator in the statistics package R.
        That is, 1/3rd of the participants will participate in 5 baseline waves of data collection,
        each one week apart, before starting RFCBT, another 1/3rd of participants will participate in
        6 baseline waves before starting RFCBT, and the final 1/3rd of participants will participate
        in 6 baseline waves before starting RFCBT. Thus, all participants will participate in 5 to 7
        weekly baseline waves. Next, each participant will participate with their trainer in up to 18
        50-minute meetings of RFCBT. In this time, each participant will participate in 6 to 9 waves
        of training data collection (one wave of data collection every 2 RFCBT meetings). After
        completion of the training, each participant will be followed for another 10 weeks during
        which they participate in 5 waves of follow-up data collection (one wave of data collection
        every 2 weeks). Thus, each participant participates in 28 to 36 weeks in the study and takes
        part in 16 to 21 waves of data collection.
  
        The investigators plan to recruit 27 adults with low income who have an elevated Response
        Style Questionnaire (RSQ)-Brooding score (>= 11), Patient Health Questionnaire (PHQ)-9 score
        (10-20), and blood pressure (systolic blood pressure [SBP]/ diastolic blood pressure [DBP]:
        >= 120 and/or 80) - that Have A Heart Clinic personnel administers regularly - and speak
        fluent English. There are no other exclusion criteria including any medical or psychological
        treatment. Patients who fulfill the above listed inclusion criteria are referred by Have A
        Heart Clinic personnel to the research team.
  
        At each wave of data collection, the investigators will administer all the surveys listed in
        this report. All questions will be administered at each wave except for the questions about
        demographic information which will be asked during Baseline-1 only.
  
        To measure blood pressure, the investigators will use an oscillometric measurement device. To
        do so, a blood pressure cuff will be placed about an inch above the elbow crease. For
        reliability purposes, blood pressure will be measured three-times with about 1 minute time
        between the measures.
  
        To measure cortisol, h-CRP, IL-6, and TNF-α levels in saliva, participants will also be asked
        to provide saliva samples. Participants will be asked to avoid eating food or drinking
        caffeine for 3 hours prior to the saliva data collection in order to prepare for the saliva
        testing.
  
        Once after the participants finish the RFCBT, they will be invited to take part in a
        semi-structured interview to explore their experiences in and acceptability of the training.
        The investigators intend to do these interviews with all participants who begin RFCBT (i.e.,
        defined as completing at least one 50-minute meeting with their trainer), including those who
        drop out of the training, in-person, by phone, or a secure video platform.
  
        The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In
        general, a participant and their trainer will identify when the participant ruminates in an
        unhelpful manner, what triggers the rumination, what function the rumination fulfills for the
        participant, and how the participant already does to stop ruminating. Building on this
        knowledge both together will change the environment to reduce the likelihood of the
        participant to ruminate, use consciously strategies to stop rumination when it occurs, and
        replace rumination by more helpful strategies. In the proposed single subject study, the
        participant and the trainer will meet in person or using a UofL approved video platform up to
        18 times for 50-minutes.
  
        Plan for Analysis of Results Following the best practice guidelines of the What Works
        Clearinghouse Standards for SCEDs, the investigators will examine consistency, intervention
        effect, immediacy, and auto-correlations for rumination, depressive symptoms, blood pressure,
        cortisol, h-CRP, IL-6, and TNF-α. The investigators will use Bayesian unknown changepoint
        models to estimate the parameters and model the treatment effect. A mixed effects model will
        be used to model the hierarchical structure of the data. The dependent variables are
        rumination, depressive symptoms, blood pressure, cortisol, h-CRP, IL-6, and TNF-α. The
        independent variable is phase. Bayesian estimation will be used to address the small sample
        nature of the data. For these statistical analyses the investigators will use R and "Just
        Another Gibbs Sampler" (JAGS). The investigators will conduct semi-structured interviews and
        analyze data using thematic analysis to generate themes associated with the data. The
        statistical program Dedoose will be utilized to facilitate this process.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single subject design
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: This is a Single subject design study. Thus, as all participants receive the intervention, there is no masking possible.
  measure: Response Style Questionnaire
  time frame: Baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 1 week after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 2 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 3 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 4 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 5 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 6 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 7 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 9 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 11 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 13 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 15 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 17 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 19 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 21 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 23 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 25 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 27 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 29 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 31 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Response Style Questionnaire
  time frame: 33 weeks after baseline 1
  description: sadness rumination, Score range: 5-20, higher score = more rumination
  measure: Patient Health Questionnaire-9
  time frame: Baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 1 week after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 2 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 3 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 4 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 5 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 6 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 7 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 9 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 11 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 13 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 15 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 17 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 19 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 21 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 23 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 25 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 27 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 29 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 31 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: Patient Health Questionnaire-9
  time frame: 33 weeks after baseline 1
  description: depressive symptoms, Score range: 0-27, higher score = more depressive symptoms
  measure: systolic blood pressure measures
  time frame: Baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 1 week after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 2 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 3 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 4 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 5 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 6 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 7 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 9 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 11 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 13 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 15 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 17 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 19 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 21 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 23 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 25 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 27 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 29 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 31 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: systolic blood pressure measures
  time frame: 33 weeks after baseline 1
  description: systolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: Baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 1 week after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 2 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 3 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 4 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 5 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 6 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 7 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 9 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 11 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 13 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 15 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 17 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 19 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 21 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 23 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 25 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 27 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 29 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 31 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  measure: diastolic blood pressure measures
  time frame: 33 weeks after baseline 1
  description: diastolic blood pressure; score range: 0-200+, higher score = higher blood pressure
  arm group label: RFCBT
  arm group type: Experimental
  description: This is a single subject design study. Thus, all participants receive Rumination-Focused Cognitive Behavior Therapy
  intervention type: Behavioral
  intervention name: Rumination-Focused Cognitive Behavior Therapy
  description: The RFCBT exclusively addresses one possible mechanism underlying depression, rumination. In general, a participant and their therapist will identify when the participant ruminates in an unhelpful manner, what triggers the rumination, what function the rumination fulfills for the participant, and how the participant already does to stop ruminating. Building on this knowledge both together will change the environment to reduce the likelihood of the participant to ruminate, use consciously strategies to stop rumination when it occurs, and replace rumination by more helpful strategies. In the proposed single subject study, the participant and the therapist will meet in person or using a UofL approved video platform up to 18 times for 50-minutes.
  arm group label: RFCBT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Patrick Possel, Dr.rer.soc.
  role: Principal Investigator
  affiliation: University of Louisville
  last name: Patrick Possel, Dr.rer.soc.
  phone: 502-852-0623
  email: patrick.possel@louisville.edu
  responsible party type: Principal Investigator
  investigator affiliation: University of Louisville
  investigator full name: Patrick Possel
  investigator title: Professor
  mesh term: Rumination Syndrome
  mesh term: Depression
  mesh term: Feeding and Eating Disorders of Childhood
  sharing ipd: No