<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/NCT03260985</url>
  </required_header>
  <id_info>
    <org_study_id>41868</org_study_id>
    <nct_id>NCT03260985</nct_id>
  </id_info>
  <brief_title>Precision Psychiatry Continuity Clinic Project</brief_title>
  <acronym>PPC</acronym>
  <official_title>Precision Psychiatry Continuity Clinic Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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 is a demonstration project focused on translating neuroscience insights into clinical&#xD;
      practice. The researchers will evaluate how neuroscience assessments may be applied in the&#xD;
      clinical setting to help inform care decisions. The aim of the study is to undertake a&#xD;
      pragmatic pilot trial to assess whether the inclusion of structured feedback from&#xD;
      neuroscience assessments has an effect on improving patient outcomes. The study will&#xD;
      investigate how neuroscience assessments can be integrated into and improve clinical care.&#xD;
      The impact of sharing information and conclusions from these assessments with psychiatric&#xD;
      providers will be explored. Outcomes will include symptoms, social/occupational function and&#xD;
      qualify of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 25, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>12 weeks</time_frame>
    <description>A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Generalized Anxiety Disorder Questionnaire (GAD-7)</measure>
    <time_frame>12 weeks</time_frame>
    <description>A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sheehan Disability Scale (SDS) of Social/Occupational Functioning</measure>
    <time_frame>12 weeks</time_frame>
    <description>Level of functioning in social, occupational, and home life domains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Burden of side effects from psychiatric medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Depressive Disorders</condition>
  <condition>Depressive Symptoms</condition>
  <condition>Anxiety Disorders and Symptoms</condition>
  <condition>Psychological Distress</condition>
  <condition>Mood Disorders</condition>
  <arm_group>
    <arm_group_label>Feedback Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. Participants randomized to the Feedback Group will have the results of this assessment shared with their psychiatric treatment team before they begin treatment. This data will be used at the full discretion of the treatment team to inform personalized treatment options. All treatment decisions remain up to the treatment providers and patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Feedback Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. However, participants randomized to the Delayed Feedback Group will not have the results of this assessment shared with their treatment team until the end of their participation in this study (12 weeks).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Feedback Report</intervention_name>
    <description>A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.</description>
    <arm_group_label>Feedback Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  Fluent and literate in English, and able to understand task instructions&#xD;
&#xD;
          -  fMRI scanning eligibility, including no evidence of any form of metal embedded in the&#xD;
             body (e.g., metal wires, nuts, bolts, screws, plates, sutures)&#xD;
&#xD;
          -  Must be referred for treatment at the Stanford Department of Psychiatry Continuity&#xD;
             Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of suicidal ideations representing imminent risk&#xD;
&#xD;
          -  General medical condition, disease or neurological disorder that interferes with the&#xD;
             assessments&#xD;
&#xD;
          -  Traumatic brain injury (history of physical brain injury or blow to the head resulting&#xD;
             in loss of consciousness greater than five minutes) and which could interfere with&#xD;
             doing the assessments&#xD;
&#xD;
          -  Severe impediment to vision, hearing and/or hand movement, likely to interfere with&#xD;
             ability to complete the assessments, or are unable and/or unlikely to follow the study&#xD;
             protocols&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Presence of acute psychosis, schizophrenia spectrum, or other psychotic disorders&#xD;
&#xD;
          -  Concurrent participation in intervention or treatment studies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Leanne Williams, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Center for Cognitive and Neurobiological Imaging (CNI)</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Leanne Williams</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03260985
org study id: 41868
nct id: NCT03260985
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a demonstration project focused on translating neuroscience insights into clinical
      practice. The researchers will evaluate how neuroscience assessments may be applied in the
      clinical setting to help inform care decisions. The aim of the study is to undertake a
      pragmatic pilot trial to assess whether the inclusion of structured feedback from
      neuroscience assessments has an effect on improving patient outcomes. The study will
      investigate how neuroscience assessments can be integrated into and improve clinical care.
      The impact of sharing information and conclusions from these assessments with psychiatric
      providers will be explored. Outcomes will include symptoms, social/occupational function and
      qualify of life.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Health Questionnaire (PHQ-9)
time frame: 12 weeks
description: A 9-item questionnaire of self-reported symptoms of major depression commonly used in research and routine clinical care
measure: Generalized Anxiety Disorder Questionnaire (GAD-7)
time frame: 12 weeks
description: A 7-item questionnaire of self-reported symptoms of generalized anxiety commonly used in research and routine clinical care
measure: Sheehan Disability Scale (SDS) of Social/Occupational Functioning
time frame: 12 weeks
description: Level of functioning in social, occupational, and home life domains
measure: Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER)
time frame: 12 weeks
description: Burden of side effects from psychiatric medication
arm group label: Feedback Group
arm group type: Experimental
description: All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. Participants randomized to the Feedback Group will have the results of this assessment shared with their psychiatric treatment team before they begin treatment. This data will be used at the full discretion of the treatment team to inform personalized treatment options. All treatment decisions remain up to the treatment providers and patient.
arm group label: Delayed Feedback Group
arm group type: No Intervention
description: All participants in the study will undergo a comprehensive neuroscience assessment including clinical questionnaires, a structured diagnostic interview, neuropsychological assessment, genetic testing, and structural and functional MRI. However, participants randomized to the Delayed Feedback Group will not have the results of this assessment shared with their treatment team until the end of their participation in this study (12 weeks).
intervention type: Other
intervention name: Feedback Report
description: A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
arm group label: Feedback Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Leanne Williams, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Leanne Williams
investigator title: Professor
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Anxiety Disorders
mesh term: Mood Disorders