<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/NCT03755401</url>
  </required_header>
  <id_info>
    <org_study_id>1UL1TR002384-02</org_study_id>
    <nct_id>NCT03755401</nct_id>
  </id_info>
  <brief_title>Post-Traumatic Stress Disorder Focused Psychodynamic Psychotherapy</brief_title>
  <acronym>RCT of TFPP</acronym>
  <official_title>A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA New York Harbor Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>CTSC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>American Psychoanalytic Association Fund for Psychoanalytic Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Psychoanalytic Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Weill Medical College of Cornell 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 randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in&#xD;
      comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not&#xD;
      responded to standard treatment at the VA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Veterans with PTSD are a highly vulnerable population with tremendous disability and unmet&#xD;
      needs. Few VA patients with PTSD now actually receive evidence-based psychotherapy because&#xD;
      current exposure-based treatments have low uptake. The project goal is to expand the range of&#xD;
      PTSD psychotherapy treatments available at Veterans Administration Medical Centers. This&#xD;
      pilot trauma recovery proposal takes the next step in translating a brief efficacious&#xD;
      psychotherapy developed and tested for panic disorder, Panic Focused Psychodynamic&#xD;
      Psychotherapy (PFPP) for Veterans with PTSD at the VA New York Harbor Healthcare System (VA&#xD;
      NYHHCS). PFPP was developed, manualized, and studied in RCTs over the past two decades. We&#xD;
      hope that Trauma-Focused Psychodynamic Psychotherapy (TFPP), an adaptation of PFPP, with its&#xD;
      high response rates in panic disorder with/without agoraphobia, and non-exposure protocol,&#xD;
      will fill crucial gaps in Veteran care. A major challenge facing psychotherapy research is&#xD;
      translating and implementing efficacious therapies to the community. No psychodynamic&#xD;
      psychotherapy for anxiety or PTSD has achieved this in the US. This pilot RCT represents a&#xD;
      paradigm shift in its approach to trauma. TFPP will be the only PTSD treatment for Veterans&#xD;
      to incorporate Veterans' input into refinement of the treatment as this project progresses.&#xD;
      TFPP targets aspects of traumatic experience and approaches Veterans' lives more broadly than&#xD;
      the symptom-focused treatments the VA currently offers our traumatized Veterans.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</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>
    <intervention_model_description>Randomized controlled trial of psychosocial interventions</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in PTSD symptoms as per DSM-5 as measured by CAPS-5</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety symptoms as measured by HARS.</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Hamilton Anxiety Rating Scale (HARS). Low score indicates fewer state anxiety symptoms, high score indicates greater state anxiety symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in reflective capacity as measured by RF score.</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Reflective Function Scale (RF). Low score indicates poor ability to reflect on relationships and self, high score, indicates better capacity to reflect on others and self.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression symptoms as measured by HDRS.</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Hamilton Depression Rating Scale (HDRS). Low score indicates few depressive symptoms, high score indicates high level of depressive burden (depression)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental and physical symptoms as measured by VR-12.</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Veterans RAND 12-Item Health Survey (VR-12). The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in work and social adjustment as measured by WSAS.</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Work and Social Adjustment Scale (WSAS). Low score indicates good social and work adjustment, high score indicates impairment socially and at work.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in degree of limitation in ability to work as measured by WLQ</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Work Limitations Questionnaire (WLQ). Low score indicates few limitations at work, high score indicates many limitations at work</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Childhood abuse history and trauma with CTQ</measure>
    <time_frame>baseline</time_frame>
    <description>Childhood Trauma Questionnaire (CTQ). Several different domains: Emotional Abuse: None=5-8; Low=9-12; Moderate=13-15; Severe=16+ Physical Abuse: None=5-7; Low=8-9; Moderate=10-12; Severe=13+ Sexual Abuse: None=5; Low=6-7; Moderate=8-12; Severe=13+ Emotional Neglect: None=5-9; Low=10-14; Moderate=15-17; Severe=18+ Physical Neglect: None=5-7; Low=8-9; Moderate=10-12; Severe=13+</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in adult separation anxiety symptoms as measured by the SCI-SAS</measure>
    <time_frame>baseline, 16 weeks (termination), 3 month follow-up</time_frame>
    <description>Separation anxiety-child and adult measure rating scale (SCI-SAS). Separate scores generated for childhood separation anxiety and adult separation anxiety. Low scores indicate few separation anxiety symptoms, high scores indicate large separation anxiety burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of life events on LEC.</measure>
    <time_frame>baseline</time_frame>
    <description>Life Events Checklist (LEC). No composite score-tracks traumatic life events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">75</enrollment>
  <condition>PTSD</condition>
  <arm_group>
    <arm_group_label>TFPP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU in this study is treatment for PTSD as currently delivered at the VA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TFPP</intervention_name>
    <description>Trauma-Focused Psychodynamic Psychotherapy</description>
    <arm_group_label>TFPP</arm_group_label>
    <other_name>psychodynamic psychotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>TAU</intervention_name>
    <description>treatment as usual at the VA for PTSD</description>
    <arm_group_label>TAU</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Reporting moderate PTSD, as defined by a CAPS score of &gt;40&#xD;
&#xD;
          -  Have at least one of the following history with CPT and/or PE:&#xD;
&#xD;
               -  offered and declined&#xD;
&#xD;
               -  dropped out of treatment&#xD;
&#xD;
               -  been determined unsuitable by their treatment team&#xD;
&#xD;
               -  received treatment but continue to experience symptoms meeting entrance criteria.&#xD;
&#xD;
          -  Require stabilization on psychiatric medication for 2 month period prior to entry into&#xD;
             study to avoid confounding treatments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of SCID-5 assessed psychotic disorder, bipolar disorder, or substance use&#xD;
             that would interfere with trial demands&#xD;
&#xD;
          -  Severe suicidality that would require immediate crisis management&#xD;
&#xD;
          -  Organic mental syndromes, delirium, or unstable medical conditions that would&#xD;
             interfere with trial demands&#xD;
&#xD;
          -  Inability to meet trial demands.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barbara Milrod, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lauren Wash</last_name>
    <phone>(212) 686-7500</phone>
    <phone_ext>3003</phone_ext>
    <email>Lauren.Wash@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cory K Chen, Ph.D.</last_name>
    <phone>(212) 686-7500</phone>
    <phone_ext>4002</phone_ext>
    <email>Cory.Chen@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>VA New York Harbor Healthcare System - Manhattan Campus</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Wash</last_name>
      <phone>212-686-7500</phone>
      <phone_ext>3003</phone_ext>
      <email>Lauren.Wash@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Cory K Chen, Ph.D.</last_name>
      <phone>212-686-7500</phone>
      <phone_ext>4002</phone_ext>
      <email>Cory.Chen@va.gov</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Busch FN, Milrod BL. Trauma-Focused Psychodynamic Psychotherapy. Psychiatr Clin North Am. 2018 Jun;41(2):277-287. doi: 10.1016/j.psc.2018.01.005.</citation>
    <PMID>29739526</PMID>
  </reference>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 7, 2022</last_update_submitted>
  <last_update_submitted_qc>November 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>psychotherapy</keyword>
  <keyword>psychodynamic psychotherapy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03755401
org study id: 1UL1TR002384-02
nct id: NCT03755401
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in
      comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not
      responded to standard treatment at the VA.
Veterans with PTSD are a highly vulnerable population with tremendous disability and unmet
      needs. Few VA patients with PTSD now actually receive evidence-based psychotherapy because
      current exposure-based treatments have low uptake. The project goal is to expand the range of
      PTSD psychotherapy treatments available at Veterans Administration Medical Centers. This
      pilot trauma recovery proposal takes the next step in translating a brief efficacious
      psychotherapy developed and tested for panic disorder, Panic Focused Psychodynamic
      Psychotherapy (PFPP) for Veterans with PTSD at the VA New York Harbor Healthcare System (VA
      NYHHCS). PFPP was developed, manualized, and studied in RCTs over the past two decades. We
      hope that Trauma-Focused Psychodynamic Psychotherapy (TFPP), an adaptation of PFPP, with its
      high response rates in panic disorder with/without agoraphobia, and non-exposure protocol,
      will fill crucial gaps in Veteran care. A major challenge facing psychotherapy research is
      translating and implementing efficacious therapies to the community. No psychodynamic
      psychotherapy for anxiety or PTSD has achieved this in the US. This pilot RCT represents a
      paradigm shift in its approach to trauma. TFPP will be the only PTSD treatment for Veterans
      to incorporate Veterans' input into refinement of the treatment as this project progresses.
      TFPP targets aspects of traumatic experience and approaches Veterans' lives more broadly than
      the symptom-focused treatments the VA currently offers our traumatized Veterans.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial of psychosocial interventions
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm
measure: Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.
measure: Change in anxiety symptoms as measured by HARS.
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Hamilton Anxiety Rating Scale (HARS). Low score indicates fewer state anxiety symptoms, high score indicates greater state anxiety symptoms
measure: Change in reflective capacity as measured by RF score.
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Reflective Function Scale (RF). Low score indicates poor ability to reflect on relationships and self, high score, indicates better capacity to reflect on others and self.
measure: Change in depression symptoms as measured by HDRS.
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Hamilton Depression Rating Scale (HDRS). Low score indicates few depressive symptoms, high score indicates high level of depressive burden (depression)
measure: Change in mental and physical symptoms as measured by VR-12.
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Veterans RAND 12-Item Health Survey (VR-12). The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
measure: Change in work and social adjustment as measured by WSAS.
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Work and Social Adjustment Scale (WSAS). Low score indicates good social and work adjustment, high score indicates impairment socially and at work.
measure: Change in degree of limitation in ability to work as measured by WLQ
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Work Limitations Questionnaire (WLQ). Low score indicates few limitations at work, high score indicates many limitations at work
measure: Childhood abuse history and trauma with CTQ
time frame: baseline
description: Childhood Trauma Questionnaire (CTQ). Several different domains: Emotional Abuse: None=5-8; Low=9-12; Moderate=13-15; Severe=16+ Physical Abuse: None=5-7; Low=8-9; Moderate=10-12; Severe=13+ Sexual Abuse: None=5; Low=6-7; Moderate=8-12; Severe=13+ Emotional Neglect: None=5-9; Low=10-14; Moderate=15-17; Severe=18+ Physical Neglect: None=5-7; Low=8-9; Moderate=10-12; Severe=13+
measure: Change in adult separation anxiety symptoms as measured by the SCI-SAS
time frame: baseline, 16 weeks (termination), 3 month follow-up
description: Separation anxiety-child and adult measure rating scale (SCI-SAS). Separate scores generated for childhood separation anxiety and adult separation anxiety. Low scores indicate few separation anxiety symptoms, high scores indicate large separation anxiety burden.
measure: Assessment of life events on LEC.
time frame: baseline
description: Life Events Checklist (LEC). No composite score-tracks traumatic life events
arm group label: TFPP
arm group type: Experimental
description: TFPP is a manualized 16-24 session psychodynamic psychotherapy targeted on trauma symptoms of PTSD
arm group label: TAU
arm group type: Active Comparator
description: TAU in this study is treatment for PTSD as currently delivered at the VA
intervention type: Other
intervention name: TFPP
description: Trauma-Focused Psychodynamic Psychotherapy
arm group label: TFPP
other name: psychodynamic psychotherapy
intervention type: Other
intervention name: TAU
description: treatment as usual at the VA for PTSD
arm group label: TAU
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Barbara Milrod, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: Lauren Wash
phone: (212) 686-7500
phone ext: 3003
email: Lauren.Wash@va.gov
last name: Cory K Chen, Ph.D.
phone: (212) 686-7500
phone ext: 4002
email: Cory.Chen@va.gov
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
citation: Busch FN, Milrod BL. Trauma-Focused Psychodynamic Psychotherapy. Psychiatr Clin North Am. 2018 Jun;41(2):277-287. doi: 10.1016/j.psc.2018.01.005.
PMID: 29739526
responsible party type: Sponsor
sharing ipd: No