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/NCT06000475</url>
    </required_header>
    <id_info>
      <org_study_id>D4627-P</org_study_id>
      <secondary_id>1I21RX004627</secondary_id>
      <nct_id>NCT06000475</nct_id>
    </id_info>
    <brief_title>Enhancing Memory in CPT for PTSD</brief_title>
    <official_title>Enhancing Memory in Cognitive Processing Therapy for Older Adults With PTSD</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>VA Office of Research and Development</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>VA Office of Research and Development</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base&#xD;
        for their efficacy, but nonresponse rates are high, particularly among older Veterans.&#xD;
        Accumulating evidence indicates that memory deficits and poor learning of therapy contents&#xD;
        adversely affect psychotherapy treatment response in PTSD. However, limited research has&#xD;
        examined methods for increasing learning of therapy contents in psychotherapy for PTSD. The&#xD;
        proposed study aims to examine the feasibility of integrating an intervention to increase&#xD;
        learning and memory of psychotherapy content into the provision of a widely used&#xD;
        psychotherapy, cognitive processing therapy (CPT), for older adults with PTSD. The ultimate&#xD;
        goal of this line of research is to develop novel rehabilitation interventions to increase&#xD;
        functioning for individuals with PTSD.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Posttraumatic stress disorder (PTSD) is prevalent among Veterans and is a substantial public&#xD;
        health burden. Several psychotherapies, including cognitive processing therapy (CPT), have a&#xD;
        strong evidence base for their efficacy in PTSD. However, many individuals show limited&#xD;
        benefit from such treatments, particularly older Veterans. One factor likely affecting&#xD;
        treatment response is poor encoding, storage, and retrieval of the skills and treatment&#xD;
        points that are learned in psychotherapy. Individuals with PTSD display deficits in learning&#xD;
        and memory, and aging is independently associated with declines in memory and executive&#xD;
        functioning. Thus, older adults with PTSD may be at heightened risk of cognitive dysfunction&#xD;
        that could impact their ability to benefit from frontline PTSD treatments. To this end,&#xD;
        pre-treatment memory functioning has been shown to consistently predict treatment response in&#xD;
        psychotherapy for PTSD. Inefficient learning and memory for psychotherapy content may be one&#xD;
        mechanism explaining this relationship, as poor learning of therapy content is linked with&#xD;
        worse treatment adherence and outcomes. The primary aim of this proposal is to examine the&#xD;
        feasibility and acceptability of integrating a novel Memory Support intervention into the&#xD;
        provision of CPT for older adults with PTSD. The Memory Support intervention was developed&#xD;
        such that specific strategies to enhance encoding and retrieval of therapy content and skills&#xD;
        can be integrated into manualized psychotherapy. However, no prior studies have integrated&#xD;
        this intervention into treatments for PTSD. The proposed project will be guided by a&#xD;
        user-centered design framework for treatment development and be conducted in three phases. In&#xD;
        the first phase, the investigators will develop a modified CPT treatment manual that&#xD;
        systematically integrates Memory Support, with clinician (n=3) and Veteran (n=3) feedback to&#xD;
        provide guidance on process and techniques. In the next phase, the investigators will conduct&#xD;
        iterative refinement of the modified treatment through a case series in older Veterans (n=3)&#xD;
        with an experienced CPT therapist. Finally, the investigators will conduct a small&#xD;
        feasibility randomized controlled trial (n=20) in which the investigators will examine&#xD;
        accrual, retention, completion, acceptability, and variability in symptom and functional&#xD;
        outcomes, as well as all procedures for a larger trial. The proposed project offers&#xD;
        substantial conceptual innovations by bridging foundational work from rehabilitation&#xD;
        neuropsychology and psychotherapy mechanisms research and will provide valuable pilot data to&#xD;
        inform a novel intervention for older Veterans with PTSD that can be tested in future&#xD;
        large-scale studies. Such approaches may be especially relevant for Veterans with&#xD;
        neurocognitive deficits (e.g., memory), potentially suggesting a target for a personalized&#xD;
        approach to mental health care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 1, 2024</start_date>
    <completion_date type="Anticipated">September 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 30, 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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <masking_description>Blinded to treatment status during feasibility trial</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>PTSD Checklist-5 (PCL-5)</measure>
      <time_frame>Through study completion, weeks 12-16 of treatment</time_frame>
      <description>Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).</description>
    </primary_outcome>
    <other_outcome>
      <measure>Client Satisfaction Questionnaire (CSQ)</measure>
      <time_frame>Through study completion, weeks 12-16 of treatment</time_frame>
      <description>8-item patient satisfaction scale; the range of the scale is from 8 to 32, where low scores are indicative of low satisfaction and high scores are indicative of high satisfaction.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Stress Disorders, Post-Traumatic</condition>
    <arm_group>
      <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard CPT as described in the treatment manual</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognitive Processing Therapy (CPT) + Memory Support</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Processing Therapy</intervention_name>
      <description>CPT as described in the treatment manual</description>
      <arm_group_label>Cognitive Processing Therapy (CPT)</arm_group_label>
      <arm_group_label>Cognitive Processing Therapy (CPT) + Memory Support</arm_group_label>
      <other_name>CPT</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Processing Therapy (CPT) + Memory Support</intervention_name>
      <description>CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.</description>
      <arm_group_label>Cognitive Processing Therapy (CPT) + Memory Support</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Veterans with DSM-5 diagnoses of PTSD via the Clinician Administered PTSD Scale&#xD;
               (CAPS-5)&#xD;
  &#xD;
            -  Age &gt;59&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  daily benzodiazepine use (due to memory impairing effects)&#xD;
  &#xD;
            -  bipolar or psychotic disorders&#xD;
  &#xD;
            -  current suicidal ideation with plan or intent&#xD;
  &#xD;
            -  current moderate or severe substance use disorder not in remission for &gt;1 mo.&#xD;
  &#xD;
            -  severe traumatic brain injury&#xD;
  &#xD;
            -  a Montreal Cognitive Assessment (MoCA) indicative of dementia&#xD;
  &#xD;
            -  or other disorders that would severely limit study participation&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>James C. Scott, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>James C Scott, PhD</last_name>
      <phone>(215) 823-5800</phone>
      <phone_ext>7138</phone_ext>
      <email>James.Scott2de50a@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Richard A Moore</last_name>
      <phone>(215) 823-5800</phone>
      <phone_ext>7916</phone_ext>
      <email>richard.moore7@va.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19104-4551</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kyong-Mi Chang, MD</last_name>
        <phone>215-823-5893</phone>
        <email>Kyong-Mi.Chang@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Richard A Moore</last_name>
        <phone>(215) 823-5800</phone>
        <phone_ext>7916</phone_ext>
        <email>richard.moore7@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>James C. Scott, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Stress Disorders, Post-Traumatic</keyword>
    <keyword>Psychotherapy</keyword>
    <keyword>Memory</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stress Disorders, Traumatic</mesh_term>
      <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06000475
  org study id: D4627-P
  secondary id: 1I21RX004627
  nct id: NCT06000475
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Several psychotherapies for posttraumatic stress disorder (PTSD) have a strong evidence base
        for their efficacy, but nonresponse rates are high, particularly among older Veterans.
        Accumulating evidence indicates that memory deficits and poor learning of therapy contents
        adversely affect psychotherapy treatment response in PTSD. However, limited research has
        examined methods for increasing learning of therapy contents in psychotherapy for PTSD. The
        proposed study aims to examine the feasibility of integrating an intervention to increase
        learning and memory of psychotherapy content into the provision of a widely used
        psychotherapy, cognitive processing therapy (CPT), for older adults with PTSD. The ultimate
        goal of this line of research is to develop novel rehabilitation interventions to increase
        functioning for individuals with PTSD.
  Posttraumatic stress disorder (PTSD) is prevalent among Veterans and is a substantial public
        health burden. Several psychotherapies, including cognitive processing therapy (CPT), have a
        strong evidence base for their efficacy in PTSD. However, many individuals show limited
        benefit from such treatments, particularly older Veterans. One factor likely affecting
        treatment response is poor encoding, storage, and retrieval of the skills and treatment
        points that are learned in psychotherapy. Individuals with PTSD display deficits in learning
        and memory, and aging is independently associated with declines in memory and executive
        functioning. Thus, older adults with PTSD may be at heightened risk of cognitive dysfunction
        that could impact their ability to benefit from frontline PTSD treatments. To this end,
        pre-treatment memory functioning has been shown to consistently predict treatment response in
        psychotherapy for PTSD. Inefficient learning and memory for psychotherapy content may be one
        mechanism explaining this relationship, as poor learning of therapy content is linked with
        worse treatment adherence and outcomes. The primary aim of this proposal is to examine the
        feasibility and acceptability of integrating a novel Memory Support intervention into the
        provision of CPT for older adults with PTSD. The Memory Support intervention was developed
        such that specific strategies to enhance encoding and retrieval of therapy content and skills
        can be integrated into manualized psychotherapy. However, no prior studies have integrated
        this intervention into treatments for PTSD. The proposed project will be guided by a
        user-centered design framework for treatment development and be conducted in three phases. In
        the first phase, the investigators will develop a modified CPT treatment manual that
        systematically integrates Memory Support, with clinician (n=3) and Veteran (n=3) feedback to
        provide guidance on process and techniques. In the next phase, the investigators will conduct
        iterative refinement of the modified treatment through a case series in older Veterans (n=3)
        with an experienced CPT therapist. Finally, the investigators will conduct a small
        feasibility randomized controlled trial (n=20) in which the investigators will examine
        accrual, retention, completion, acceptability, and variability in symptom and functional
        outcomes, as well as all procedures for a larger trial. The proposed project offers
        substantial conceptual innovations by bridging foundational work from rehabilitation
        neuropsychology and psychotherapy mechanisms research and will provide valuable pilot data to
        inform a novel intervention for older Veterans with PTSD that can be tested in future
        large-scale studies. Such approaches may be especially relevant for Veterans with
        neurocognitive deficits (e.g., memory), potentially suggesting a target for a personalized
        approach to mental health care.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  masking description: Blinded to treatment status during feasibility trial
  measure: PTSD Checklist-5 (PCL-5)
  time frame: Through study completion, weeks 12-16 of treatment
  description: Questionnaire for symptoms of PTSD; the range of the scale is from 0 (no symptoms) to 80 (maximal symptoms).
  measure: Client Satisfaction Questionnaire (CSQ)
  time frame: Through study completion, weeks 12-16 of treatment
  description: 8-item patient satisfaction scale; the range of the scale is from 8 to 32, where low scores are indicative of low satisfaction and high scores are indicative of high satisfaction.
  arm group label: Cognitive Processing Therapy (CPT)
  arm group type: Active Comparator
  description: Standard CPT as described in the treatment manual
  arm group label: Cognitive Processing Therapy (CPT) + Memory Support
  arm group type: Experimental
  description: CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
  intervention type: Behavioral
  intervention name: Cognitive Processing Therapy
  description: CPT as described in the treatment manual
  arm group label: Cognitive Processing Therapy (CPT)
  arm group label: Cognitive Processing Therapy (CPT) + Memory Support
  other name: CPT
  intervention type: Behavioral
  intervention name: Cognitive Processing Therapy (CPT) + Memory Support
  description: CPT+Memory support will also incorporate frequent and intentional use of strategies to enhance learning and memory of this content.
  arm group label: Cognitive Processing Therapy (CPT) + Memory Support
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  last name: James C. Scott, PhD
  role: Principal Investigator
  affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
  last name: James C Scott, PhD
  phone: (215) 823-5800
  phone ext: 7138
  email: James.Scott2de50a@va.gov
  last name: Richard A Moore
  phone: (215) 823-5800
  phone ext: 7916
  email: richard.moore7@va.gov
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: No