<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/NCT01702168</url>
  </required_header>
  <id_info>
    <org_study_id>1K23MH096029-01A1</org_study_id>
    <nct_id>NCT01702168</nct_id>
  </id_info>
  <brief_title>Implementation of CPT for PTSD in Diverse Communities</brief_title>
  <official_title>Implementation of Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) in Diverse Communities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To identify, assess, and address organizational context and provider-level barriers and&#xD;
      facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods&#xD;
      approach in a diverse community mental health center (CMHC), Massachusetts General Hospital&#xD;
      Chelsea Health Clinic (MGH Chelsea).&#xD;
&#xD;
      Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate,&#xD;
      heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider&#xD;
      motivation to learn EBT.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EBPAS-50</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Evidence Based Practice Attitudes Scale (EBPAS-50) is a brief, validated measure of clinician attitudes towards evidence based treatments (EBTs) containing four subscales: 1) Appeal measures whether the provider would adopt a new practice if it is intuitively appealing, or is being used by colleagues who are happy with it; 2)Requirement measures whether provider would adopt a practice if it is required by an agency, supervisor, or state; 3)Openness measures whether the provider is generally open to trying new interventions and would be willing to try or use new types of therapy, and 4)Divergence measures whether the provider perceives research-based interventions as not clinically useful or less important than clinical experience.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ORC</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Organizational Readiness for Change (ORC) measures organizational climate. The ORC is defined as the organizational and staff factors related to adoption of new technologies. ORC is conceptualized as a set of factors that are necessary for sustained change. These factors include motivation, resources, staff attributes, and organizational climate. Readiness for change has been associated with successful dissemination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>OSC</measure>
    <time_frame>up to 5 years</time_frame>
    <description>The Organizational Social Context (OSC) measures the following domains: structure, culture, psychological and organizational climate, and work attitudes. The OSC measurement system is a validated measure guided by a model of social context that composes both organizational(structure and culture) and individual (work attitudes and behavior) level constructs, including individual and shared perceptions (psychological and organizational climate) that are believed to mediate the impact of the organization on the individual. The OSC measurement system includes 105 items that form 16 first order factors and seven second order factors confirmed in national samples of social and mental health service organizations. These factors are grouped by the domains of structure, culture, psychological and organizational climate, and work attitudes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Stress Disorders, Post-Traumatic</condition>
  <arm_group>
    <arm_group_label>CBT Training</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Provider training: Cognitive Processing Therapy (CPT)</intervention_name>
    <arm_group_label>CBT Training</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will be working with community mental health workers and stakeholders at a community&#xD;
        clinic, MGH Chelsea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be over 18 years of age&#xD;
&#xD;
          -  Speak English&#xD;
&#xD;
          -  Be employed at least part time at MGH&#xD;
&#xD;
          -  Willing to have focus group/interview audiotaped and transcribed for data analysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to meet the above inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Massachusetts General Hospital Chelsea Health Center</name>
      <address>
        <city>Chelsea</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>March 6, 2019</last_update_submitted>
  <last_update_submitted_qc>March 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Luana Marques</investigator_full_name>
    <investigator_title>Assistant in Psychology</investigator_title>
  </responsible_party>
  <keyword>PTSD</keyword>
  <keyword>EBT</keyword>
  <keyword>EST</keyword>
  <keyword>Community</keyword>
  <keyword>Latino</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>
  <!-- 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/NCT01702168
org study id: 1K23MH096029-01A1
nct id: NCT01702168
lead sponsor: 
collaborator: 
has dmc: Yes
Aim: To identify, assess, and address organizational context and provider-level barriers and
      facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods
      approach in a diverse community mental health center (CMHC), Massachusetts General Hospital
      Chelsea Health Clinic (MGH Chelsea).

      Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate,
      heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider
      motivation to learn EBT.
observational model: Cohort
time perspective: Prospective
measure: EBPAS-50
time frame: up to 5 years
description: Evidence Based Practice Attitudes Scale (EBPAS-50) is a brief, validated measure of clinician attitudes towards evidence based treatments (EBTs) containing four subscales: 1) Appeal measures whether the provider would adopt a new practice if it is intuitively appealing, or is being used by colleagues who are happy with it; 2)Requirement measures whether provider would adopt a practice if it is required by an agency, supervisor, or state; 3)Openness measures whether the provider is generally open to trying new interventions and would be willing to try or use new types of therapy, and 4)Divergence measures whether the provider perceives research-based interventions as not clinically useful or less important than clinical experience.
measure: ORC
time frame: up to 5 years
description: Organizational Readiness for Change (ORC) measures organizational climate. The ORC is defined as the organizational and staff factors related to adoption of new technologies. ORC is conceptualized as a set of factors that are necessary for sustained change. These factors include motivation, resources, staff attributes, and organizational climate. Readiness for change has been associated with successful dissemination.
measure: OSC
time frame: up to 5 years
description: The Organizational Social Context (OSC) measures the following domains: structure, culture, psychological and organizational climate, and work attitudes. The OSC measurement system is a validated measure guided by a model of social context that composes both organizational(structure and culture) and individual (work attitudes and behavior) level constructs, including individual and shared perceptions (psychological and organizational climate) that are believed to mediate the impact of the organization on the individual. The OSC measurement system includes 105 items that form 16 first order factors and seven second order factors confirmed in national samples of social and mental health service organizations. These factors are grouped by the domains of structure, culture, psychological and organizational climate, and work attitudes.
arm group label: CBT Training
intervention type: Other
intervention name: Provider training: Cognitive Processing Therapy (CPT)
arm group label: CBT Training
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Luana Marques
investigator title: Assistant in Psychology
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic