<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/NCT04415541</url>
  </required_header>
  <id_info>
    <org_study_id>2000028087</org_study_id>
    <nct_id>NCT04415541</nct_id>
  </id_info>
  <brief_title>Psychodynamic Psychotherapy for Psychosis</brief_title>
  <official_title>Psychodynamic Psychotherapy for Psychosis: An Empirical Pilot Study of Efficacy, Therapeutic Action, and Machine Learning Analysis of Within-Session Speech and Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Psychoanalytic Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale 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>
      The broad goals of our pilot study are to (1) determine whether psychodynamic psychotherapy&#xD;
      for psychosis (PPfP), relative to treatment as usual (TaU), can maintain or augment clinical&#xD;
      and functional benefits for patients who have achieved initial recovery in our coordinated&#xD;
      specialty care (CSC) early psychosis treatment program; (2) to conduct novel empirical study&#xD;
      of how various psychodynamic factors may inform candidate selection, mediate therapeutic&#xD;
      effects, and influence relational aspects of the therapy; and (3) to conduct a detailed study&#xD;
      of how features of therapist and patient speech and behavior influence therapeutic outcomes,&#xD;
      therapeutic alliance alliance, and relational process. This registration focuses on the first&#xD;
      goal.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    COVID&#xD;
  </why_stopped>
  <start_date type="Anticipated">May 2021</start_date>
  <completion_date type="Anticipated">August 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Symptom Severity</measure>
    <time_frame>From enrollment up to 5 years from enrollment.</time_frame>
    <description>The Positive and Negative Symptom Scale (PANSS) will be used. This is a 30 item scale. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Items are summed to obtain an overall score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Functioning - Social</measure>
    <time_frame>From enrollment up to 5 years from enrollment.</time_frame>
    <description>The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Functioning - Role</measure>
    <time_frame>From enrollment up to 5 years from enrollment.</time_frame>
    <description>The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity (Positive Symptoms)</measure>
    <time_frame>From enrollment up to 5 years from enrollment.</time_frame>
    <description>The positive symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain a positive symptom score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom Severity (Negative Symptoms)</measure>
    <time_frame>From enrollment up to 5 years from enrollment.</time_frame>
    <description>The negative symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain an overall score.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Psychotic Disorders</condition>
  <arm_group>
    <arm_group_label>Psychodynamic Psychotheray</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Following Coordinated Specialty Care, we will offer weekly psychodynamic psychotherapy and medication management sessions which will be conducted solely by the PI, Keith Gallagher, in the initial pilot period. Consent will be obtained to record audio and video of the sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Following Coordinated Specialty Care, patients will be referred to general mental health providers in the community, which would typically include less intensive and frequent psychotherapy by a social worker or psychologist as well as medication management by a psychiatrist who may not be a specialist in psychotic disorders.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychodynamic Psychotherapy</intervention_name>
    <description>Intensive psychotherapy that is psychodynamically oriented.</description>
    <arm_group_label>Psychodynamic Psychotheray</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Conventional treatment offered in the community.</description>
    <arm_group_label>Treatment as Usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  completed the 2-3 year Coordinated Specialty Care (CSC) program&#xD;
&#xD;
          -  judged by present provider to be in an intermediate or advanced phase of recovery&#xD;
&#xD;
          -  had first episode of psychosis within the 3 years prior to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  established diagnosis of primary affective disorder, psychosis secondary to substance&#xD;
             use or a medical illness&#xD;
&#xD;
          -  inability to communicate in English&#xD;
&#xD;
          -  eligibility for Department of Developmental Services&#xD;
&#xD;
          -  legally mandated to enter treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Gallagher, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic 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/NCT04415541
org study id: 2000028087
nct id: NCT04415541
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The broad goals of our pilot study are to (1) determine whether psychodynamic psychotherapy
      for psychosis (PPfP), relative to treatment as usual (TaU), can maintain or augment clinical
      and functional benefits for patients who have achieved initial recovery in our coordinated
      specialty care (CSC) early psychosis treatment program; (2) to conduct novel empirical study
      of how various psychodynamic factors may inform candidate selection, mediate therapeutic
      effects, and influence relational aspects of the therapy; and (3) to conduct a detailed study
      of how features of therapist and patient speech and behavior influence therapeutic outcomes,
      therapeutic alliance alliance, and relational process. This registration focuses on the first
      goal.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Symptom Severity
time frame: From enrollment up to 5 years from enrollment.
description: The Positive and Negative Symptom Scale (PANSS) will be used. This is a 30 item scale. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Items are summed to obtain an overall score.
measure: Overall Functioning - Social
time frame: From enrollment up to 5 years from enrollment.
description: The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
measure: Overall Functioning - Role
time frame: From enrollment up to 5 years from enrollment.
description: The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
measure: Symptom Severity (Positive Symptoms)
time frame: From enrollment up to 5 years from enrollment.
description: The positive symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain a positive symptom score.
measure: Symptom Severity (Negative Symptoms)
time frame: From enrollment up to 5 years from enrollment.
description: The negative symptoms subscale of the Positive and Negative Symptom Scale (PANSS) will be used. Each item is measured on a 7-point scale from 1 (absent) to 7 (extreme). Subscale items are summed to obtain an overall score.
arm group label: Psychodynamic Psychotheray
arm group type: Experimental
description: Following Coordinated Specialty Care, we will offer weekly psychodynamic psychotherapy and medication management sessions which will be conducted solely by the PI, Keith Gallagher, in the initial pilot period. Consent will be obtained to record audio and video of the sessions
arm group label: Treatment as Usual
arm group type: Active Comparator
description: Following Coordinated Specialty Care, patients will be referred to general mental health providers in the community, which would typically include less intensive and frequent psychotherapy by a social worker or psychologist as well as medication management by a psychiatrist who may not be a specialist in psychotic disorders.
intervention type: Behavioral
intervention name: Psychodynamic Psychotherapy
description: Intensive psychotherapy that is psychodynamically oriented.
arm group label: Psychodynamic Psychotheray
intervention type: Behavioral
intervention name: Usual Care
description: Conventional treatment offered in the community.
arm group label: Treatment as Usual
criteria: 
gender: All
minimum age: 16 Years
maximum age: 35 Years
healthy volunteers: No
last name: Keith Gallagher, MD
role: Principal Investigator
affiliation: Yale University
responsible party type: Sponsor
mesh term: Psychotic Disorders