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/NCT06037785</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00007840</org_study_id>
      <secondary_id>1R21NR020967-01</secondary_id>
      <nct_id>NCT06037785</nct_id>
    </id_info>
    <brief_title>Self-Management Interventions After an ICD Shock</brief_title>
    <official_title>Biobehavioral Intervention to Reduce PTSD After ICD Shock</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>East Carolina University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>National Institute of Nursing Research (NINR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Washington</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>
        This study, &quot;Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock,&quot;&#xD;
        addresses a critical need in cardiology care by describing the feasibility and acceptability&#xD;
        of a timely, highly promising, electronically-delivered intervention for patients who have&#xD;
        recently received an ICD delivered shock. The study intervention and outcomes are designed to&#xD;
        reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the&#xD;
        development of severe distress and post-traumatic stress disorder (PTSD), and ultimately&#xD;
        promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial&#xD;
        (N=60, 30/group). The purpose is to determine feasibility and potential effects of a&#xD;
        self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered&#xD;
        during the critical 1 month period after an ICD shock when distress is high. The intervention&#xD;
        will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to&#xD;
        assess the sustainability of intervention effects and determine if the incidence of PTSD is&#xD;
        reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized&#xD;
        learning through 4 self-paced, web-based modules. The study interventions are delivered at a&#xD;
        crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed.&#xD;
        The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC&#xD;
        alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2)&#xD;
        describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total&#xD;
        daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and&#xD;
        self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess&#xD;
        feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to&#xD;
        describe differential responses to the SPSM intervention. This study fills a significant gap&#xD;
        in the care of patients with an ICD, through the systematic testing of a brief, novel and&#xD;
        cost-effective intervention that provides the knowledge and skills to improve quality of&#xD;
        life. Study findings will be used to design future larger RCTs to test intervention&#xD;
        effectiveness for more diverse samples and settings.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Double (Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ICD Shock anxiety</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total daily physical activity(steps/day)</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>PHQ-9, 0-27. Higher is higher depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PTSD Symptoms</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life-Physical and Mental</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>PROMIS Global v 2.0, 0-50. Higher is higher qol.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Efficacy Expectation</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Outcome expectation, 0-90. Higher is higher OE.</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>OE Scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Salivary cortisol</measure>
      <time_frame>Baseline, 1, 6 months</time_frame>
      <description>Cortisol in saliva, the range in humans varies. measured in pg/ml.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feasibility</measure>
      <time_frame>6 months</time_frame>
      <description>Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible &amp; enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Acceptability</measure>
      <time_frame>6 months</time_frame>
      <description>Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires &amp; data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety</measure>
      <time_frame>2 years</time_frame>
      <description>Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Implantable Defibrillator User</condition>
    <condition>Stress Reaction</condition>
    <condition>Ptsd</condition>
    <condition>Stress Management</condition>
    <condition>Social Cognitive Theory</condition>
    <arm_group>
      <arm_group_label>SPSM intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Heart rate self monitoring Online shock management modules</description>
    </arm_group>
    <arm_group>
      <arm_group_label>usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Self-Paced Self-Management (SPSM)</intervention_name>
      <description>(SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.</description>
      <arm_group_label>SPSM intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          1) ICD implant for primary or secondary prevention of sudden cardiac arrest (SCA), 2)&#xD;
          receipt of at least 1 ICD shock, appropriate or inappropriate, one week prior to&#xD;
          enrollment; 3) able to read, speak and write English; 4) access to online resources and&#xD;
          telephone for study duration.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1) current diagnosis of PTSD, schizophrenia or bipolar disorder; 2) Short BLESSED score &gt;6&#xD;
          indicating cognitive dysfunction [73]; 3) age &lt;18 years; 4) AUDIT-C score ≥4 for alcohol&#xD;
          use [74]; and 5) regular non-medical use of illicit drugs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cynthia M Dougherty, ARNP, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Cynthia M Dougherty, ARNP, PhD</last_name>
      <phone>206 221-7927</phone>
      <email>cindyd@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Cynthia M. Dougherty</investigator_full_name>
      <investigator_title>Adjunct Associate Professor: School of Medicine</investigator_title>
    </responsible_party>
    <keyword>implantable cardioverter defibrillator</keyword>
    <keyword>ptsd</keyword>
    <keyword>stress management</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>1 year after trial completion, available for up to 5 years after trial completion</ipd_time_frame>
      <ipd_access_criteria>Contact PI</ipd_access_criteria>
      <ipd_url>https://nursing.uw.edu/person/cynthia-dougherty/</ipd_url>
    </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/NCT06037785
  org study id: STUDY00007840
  secondary id: 1R21NR020967-01
  nct id: NCT06037785
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study, "Biobehavioral Intervention to Reduce PTSD Symptoms After an ICD Shock,"
        addresses a critical need in cardiology care by describing the feasibility and acceptability
        of a timely, highly promising, electronically-delivered intervention for patients who have
        recently received an ICD delivered shock. The study intervention and outcomes are designed to
        reduce anxiety, enhance return to activities of daily living (ADLs), and prevent the
        development of severe distress and post-traumatic stress disorder (PTSD), and ultimately
        promote quality of life. The study is a two-arm, embedded mixed methods, randomized trial
        (N=60, 30/group). The purpose is to determine feasibility and potential effects of a
        self-management intervention (SPSM) plus usual care (UC) compared to UC alone, delivered
        during the critical 1 month period after an ICD shock when distress is high. The intervention
        will be delivered over 1 month following an ICD shock; a 6-month follow-up will be used to
        assess the sustainability of intervention effects and determine if the incidence of PTSD is
        reduced. SPSM includes: 1) training in heart rate (HR) self-monitoring; and 2) individualized
        learning through 4 self-paced, web-based modules. The study interventions are delivered at a
        crucial time, closely after an ICD shock when stress is high, but PTSD has not yet developed.
        The specific aims are to: 1) examine the effects of the SPSM intervention plus UC vs. UC
        alone on the primary outcome of ICD shock anxiety at 1 and 6 months post-shock event, 2)
        describe the impact of SPSM plus UC compared to UC alone on the secondary outcomes of total
        daily physical activity, depression, PTSD symptoms, QOL, salivary cortisol levels, and
        self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess
        feasibility, acceptability, and safety of the SPSM intervention, SDOH will be used to
        describe differential responses to the SPSM intervention. This study fills a significant gap
        in the care of patients with an ICD, through the systematic testing of a brief, novel and
        cost-effective intervention that provides the knowledge and skills to improve quality of
        life. Study findings will be used to design future larger RCTs to test intervention
        effectiveness for more diverse samples and settings.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Care Provider, Outcomes Assessor)
  measure: ICD Shock anxiety
  time frame: Baseline, 1, 6 months
  description: Florida Shock Anxiety Scale: range 1-50, higher is higher anxiety.
  measure: Total daily physical activity(steps/day)
  time frame: Baseline, 1, 6 months
  description: Step Watch Activity Monitor, 0-unlimited number of steps. Higher is more steps.
  measure: Depression
  time frame: Baseline, 1, 6 months
  description: PHQ-9, 0-27. Higher is higher depression.
  measure: PTSD Symptoms
  time frame: Baseline, 1, 6 months
  description: Post-traumatic Stress Disorder Checklist PCL-5, 0-80. Higher is higher PTSD symtpoms
  measure: Quality of Life-Physical and Mental
  time frame: Baseline, 1, 6 months
  description: PROMIS Global v 2.0, 0-50. Higher is higher qol.
  measure: Self-Efficacy Expectation
  time frame: Baseline, 1, 6 months
  description: Self-Efficacy Expectations-SE scale, 0-60, Higher is more self-efficacy
  measure: Outcome expectation, 0-90. Higher is higher OE.
  time frame: Baseline, 1, 6 months
  description: OE Scale
  measure: Salivary cortisol
  time frame: Baseline, 1, 6 months
  description: Cortisol in saliva, the range in humans varies. measured in pg/ml.
  measure: Feasibility
  time frame: 6 months
  description: Feasibility will be measured using patient recruitment and contact rates (reach within 1-3 days of shock, number screened, eligible & enrolled, proportion eligible vs agree to participate). Each of these variables creates a number for the total study.
  measure: Acceptability
  time frame: 6 months
  description: Acceptability of interventions and materials measured in terms of patient burden (time to complete questionnaires & data collection, ease in understanding, implementing the intervention). These are qualitative open ended answers to questions and do not produce a number.
  measure: Safety
  time frame: 2 years
  description: Safety: major adverse cardiac events, including mortality (all cause and cardiac). This is measured as yes or no.
  arm group label: SPSM intervention
  arm group type: Experimental
  description: Heart rate self monitoring Online shock management modules
  arm group label: usual care
  arm group type: No Intervention
  description: standard observation and post-ICD shock care at each clinic that includes ICD interrogations monitored in-person or via home monitor
  intervention type: Behavioral
  intervention name: Self-Paced Self-Management (SPSM)
  description: (SPSM) consists of two components: 1) HR Self-monitoring, and 2) online Shock Management modules (N=4) with weekly telephone coaching, completed over 1 month.
  arm group label: SPSM intervention
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cynthia M Dougherty, ARNP, PhD
  role: Principal Investigator
  affiliation: University of Washington
  last name: Cynthia M Dougherty, ARNP, PhD
  phone: 206 221-7927
  email: cindyd@uw.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Cynthia M. Dougherty
  investigator title: Adjunct Associate Professor: School of Medicine
  mesh term: Fractures, Stress
  sharing ipd: Yes
  ipd description: To support efforts by other researchers in replicating this study, and clinicians and healthcare systems to implement the interventions, we will 1) share the detailed study protocol, patient provider intervention materials, measures, and tools; 2) share a de-identified dataset.
  ipd info type: Study Protocol
  ipd time frame: 1 year after trial completion, available for up to 5 years after trial completion
  ipd access criteria: Contact PI
  ipd url: https://nursing.uw.edu/person/cynthia-dougherty/