<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/NCT03026127</url>
  </required_header>
  <id_info>
    <org_study_id>1603017115</org_study_id>
    <secondary_id>5R33MH110542</secondary_id>
    <secondary_id>1R61MH110542</secondary_id>
    <nct_id>NCT03026127</nct_id>
  </id_info>
  <brief_title>A Novel Cognitive Reappraisal Intervention for Suicide Prevention</brief_title>
  <acronym>CRISP</acronym>
  <official_title>A Novel Cognitive Reappraisal Intervention for Suicide Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rutgers University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell University</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>
      The goal of this trial is to refine and test a novel emotion-regulation based psychosocial&#xD;
      intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years&#xD;
      old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal&#xD;
      ideation or suicide attempt).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Investigators developed a novel psychosocial intervention called &quot;Cognitive Reappraisal&#xD;
      Intervention for Suicide Prevention (CRISP),&quot; which aims to improve cognitive reappraisal&#xD;
      ability (i.e. the ability to modify the appraisal of a situation to alter its emotional&#xD;
      significance) (target), and reduce suicide risk (outcome). The conceptual framework views&#xD;
      suicidal ideation and behavior as failed attempts to regulate negative emotions and by&#xD;
      improving cognitive reappraisal, an effective emotion regulation strategy, the investigators&#xD;
      expect to reduce suicide risk. This theory is supported by studies showing that unsuccessful&#xD;
      attempts to regulate negative emotions and decreased cognitive reappraisal are associated&#xD;
      with increased suicidal ideation and behavior.&#xD;
&#xD;
      The R61 phase is a proof-of-principle phase and its goals are to optimize CRISP and test its&#xD;
      engagement with cognitive reappraisal. Certified social workers will administer 12 weekly&#xD;
      sessions of CRISP to 40 middle-aged and older adults (50-90 years old) after a&#xD;
      suicide-related hospitalization. Research assistants, unaware of the study aims, will conduct&#xD;
      assessments at study entry (hospital admission), discharge, 6 and 12 weeks post-discharge.&#xD;
      Target engagement will be assessed with EEG assessments during a standard pictured-based&#xD;
      stimuli and our novel cognitive reappraisal paradigm.&#xD;
&#xD;
      The R33 phase aims to provide further evidence of target engagement of the optimized CRISP in&#xD;
      a larger sample, evaluate the relationship of cognitive reappraisal with suicide risk as&#xD;
      measured with Columbia Suicide Severity Rating Scale (C-SSRS) and estimate implementation&#xD;
      parameters for a large-scale clinical trial. A different sample of 90 middle-aged and older&#xD;
      adults (using the same inclusion/exclusion criteria as for the R61 phase) will be randomized&#xD;
      to CRISP or to Supportive Therapy (ST, a control treatment not designed to improve emotion&#xD;
      regulation). Assessments will be conducted on admission, at discharge, and at 6, 12 and 24&#xD;
      weeks post-discharge. Primary aims are: 1) CRISP participants will show improvement in&#xD;
      cognitive reappraisal ability from discharge to end of treatment; and 2) improvement in&#xD;
      cognitive reappraisal ability will be associated with suicide risk over 24 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 28, 2017</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotion Regulation, as measured by the Electroencephalogram (EEG), Autobiographical Affective Regulation Task (AART), and a standard picture-based emotion regulation task.</measure>
    <time_frame>Baseline, 6, 12, and 24 weeks</time_frame>
    <description>A composite measure of the above tasks with the EEG will be analyzed to assess the patient's cognitive reappraisal ability.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change in Suicide Severity, as measured by the Columbia Suicide Severity Rating Scale (CSSR-S)</measure>
    <time_frame>Baseline, Weeks 1-24</time_frame>
    <description>The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-10, with lower numbers indicating less severity and higher numbers more severity.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Suicide Prevention</condition>
  <arm_group>
    <arm_group_label>CRISP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supportive Therapy (ST)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Reappraisal Intervention for Suicide Prevention</intervention_name>
    <description>Cognitive Reappraisal Intervention for Suicide Prevention, or CRISP, is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.</description>
    <arm_group_label>CRISP</arm_group_label>
    <other_name>CRISP</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supportive Therapy</intervention_name>
    <description>ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors</description>
    <arm_group_label>Supportive Therapy (ST)</arm_group_label>
    <other_name>ST</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  50 years and older&#xD;
&#xD;
          -  Diagnosis (based on SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any&#xD;
             DSM-5 depression or anxiety diagnosis, including major depressive disorder, bipolar&#xD;
             depression, depressive disorder Not Elsewhere Classified, anxiety disorder Not&#xD;
             Elsewhere Classified, adjustment disorder with anxiety and depressed mood (but without&#xD;
             any of the diagnoses shown under Exclusion Criteria)&#xD;
&#xD;
          -  Recent hospitalization for suicidal ideation or suicide attempt. At hospital&#xD;
             admission, Columbia Suicide Severity Rating Scale greater or equal to 3, &quot;Active&#xD;
             Suicidal Ideation with any methods or a suicide attempt.&quot;&#xD;
&#xD;
          -  Patients with any degree of suicidal ideation at discharge (Columbia Suicide Severity&#xD;
             Rating greater or equal to 0) will be included.&#xD;
&#xD;
          -  Patients who are on psychotropics and on after-care community psychotherapy will also&#xD;
             be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or current diagnosis of Psychotic Disorders; Current Diagnosis of Bipolar I or&#xD;
             Bipolar II, with current episode hypomanic, manic or mixed; Diagnosis of Dementia.&#xD;
&#xD;
          -  Cognitive Impairment: Mini Mental State Exam (MMSE) &lt; 24.&#xD;
&#xD;
          -  Acute or severe medical illness (i.e. delirium; decompensated cardiac, liver, or&#xD;
             kidney failure; major surgery; stroke or myocardial infarction during the three months&#xD;
             prior to entry.&#xD;
&#xD;
          -  Aphasia, sensory problems, and/or inability to speak English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dimitris Kiosses, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dimitris Kiosses, PhD</last_name>
    <phone>9149974381</phone>
    <email>dkiosses@med.cornell.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laurie Evans, MS</last_name>
    <phone>9146829100</phone>
    <phone_ext>1012570</phone_ext>
    <email>lad9011@med.cornell.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dimitris Kiosses, PhD</last_name>
      <phone>914-997-4381</phone>
      <email>dkiosses@med.cornell.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laurie Evans, MS</last_name>
      <phone>914-682-9100</phone>
      <phone_ext>1012570</phone_ext>
      <email>lad9011@med.cornell.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 24, 2023</last_update_submitted>
  <last_update_submitted_qc>May 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Suicide</keyword>
  <keyword>Middle-aged and Older Adults</keyword>
  <keyword>Cognitive Reappraisal</keyword>
  <keyword>Emotion Regulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide Prevention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.</ipd_description>
    <ipd_time_frame>Data will be available as per NIH's data sharing policy.</ipd_time_frame>
    <ipd_access_criteria>Access criteria is determined by NIH and can be requested by applying online.</ipd_access_criteria>
    <ipd_url>https://nda.nih.gov/</ipd_url>
  </patient_data>
  <!-- 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/NCT03026127
org study id: 1603017115
secondary id: 5R33MH110542
secondary id: 1R61MH110542
nct id: NCT03026127
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The goal of this trial is to refine and test a novel emotion-regulation based psychosocial
      intervention designed to reduce suicide risk in middle-aged and older adults (50-90 years
      old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal
      ideation or suicide attempt).
The Investigators developed a novel psychosocial intervention called "Cognitive Reappraisal
      Intervention for Suicide Prevention (CRISP)," which aims to improve cognitive reappraisal
      ability (i.e. the ability to modify the appraisal of a situation to alter its emotional
      significance) (target), and reduce suicide risk (outcome). The conceptual framework views
      suicidal ideation and behavior as failed attempts to regulate negative emotions and by
      improving cognitive reappraisal, an effective emotion regulation strategy, the investigators
      expect to reduce suicide risk. This theory is supported by studies showing that unsuccessful
      attempts to regulate negative emotions and decreased cognitive reappraisal are associated
      with increased suicidal ideation and behavior.

      The R61 phase is a proof-of-principle phase and its goals are to optimize CRISP and test its
      engagement with cognitive reappraisal. Certified social workers will administer 12 weekly
      sessions of CRISP to 40 middle-aged and older adults (50-90 years old) after a
      suicide-related hospitalization. Research assistants, unaware of the study aims, will conduct
      assessments at study entry (hospital admission), discharge, 6 and 12 weeks post-discharge.
      Target engagement will be assessed with EEG assessments during a standard pictured-based
      stimuli and our novel cognitive reappraisal paradigm.

      The R33 phase aims to provide further evidence of target engagement of the optimized CRISP in
      a larger sample, evaluate the relationship of cognitive reappraisal with suicide risk as
      measured with Columbia Suicide Severity Rating Scale (C-SSRS) and estimate implementation
      parameters for a large-scale clinical trial. A different sample of 90 middle-aged and older
      adults (using the same inclusion/exclusion criteria as for the R61 phase) will be randomized
      to CRISP or to Supportive Therapy (ST, a control treatment not designed to improve emotion
      regulation). Assessments will be conducted on admission, at discharge, and at 6, 12 and 24
      weeks post-discharge. Primary aims are: 1) CRISP participants will show improvement in
      cognitive reappraisal ability from discharge to end of treatment; and 2) improvement in
      cognitive reappraisal ability will be associated with suicide risk over 24 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Emotion Regulation, as measured by the Electroencephalogram (EEG), Autobiographical Affective Regulation Task (AART), and a standard picture-based emotion regulation task.
time frame: Baseline, 6, 12, and 24 weeks
description: A composite measure of the above tasks with the EEG will be analyzed to assess the patient's cognitive reappraisal ability.
measure: Change in Suicide Severity, as measured by the Columbia Suicide Severity Rating Scale (CSSR-S)
time frame: Baseline, Weeks 1-24
description: The CSSR-S assesses risk for suicide, specifically severity of thoughts, intensity of thoughts, behavior and lethality. Questions are scored in categories, 1-10, with lower numbers indicating less severity and higher numbers more severity.
arm group label: CRISP
arm group type: Experimental
description: Cognitive Reappraisal Intervention for Suicide Prevention (CRISP) is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.
arm group label: Supportive Therapy (ST)
arm group type: Active Comparator
description: Supportive Therapy focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
intervention type: Behavioral
intervention name: Cognitive Reappraisal Intervention for Suicide Prevention
description: Cognitive Reappraisal Intervention for Suicide Prevention, or CRISP, is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.
arm group label: CRISP
other name: CRISP
intervention type: Behavioral
intervention name: Supportive Therapy
description: ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors
arm group label: Supportive Therapy (ST)
other name: ST
criteria: 
gender: All
minimum age: 50 Years
maximum age: 90 Years
healthy volunteers: No
last name: Dimitris Kiosses, PhD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Dimitris Kiosses, PhD
phone: 9149974381
email: dkiosses@med.cornell.edu
last name: Laurie Evans, MS
phone: 9146829100
phone ext: 1012570
email: lad9011@med.cornell.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicide Prevention
sharing ipd: Yes
ipd description: De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
ipd time frame: Data will be available as per NIH's data sharing policy.
ipd access criteria: Access criteria is determined by NIH and can be requested by applying online.
ipd url: https://nda.nih.gov/