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/NCT06035562</url>
    </required_header>
    <id_info>
      <org_study_id>HS26055 (H2023:201)</org_study_id>
      <nct_id>NCT06035562</nct_id>
    </id_info>
    <brief_title>Promoting Positive Emotional Functioning in Police and Military Populations</brief_title>
    <official_title>Promoting Positive Emotional Functioning in Police and Military Populations</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Manitoba</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study will examine whether actively serving and veteran members of the Canadian Armed&#xD;
        Forces (CAF) and Royal Canadian Mounted Police (RCMP) who complete a treatment targeting&#xD;
        anhedonia symptoms and amplifying positive emotional processing: 1) experience significant&#xD;
        symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased&#xD;
        experience of positive emotions; 3) report improvements to broad functioning and quality of&#xD;
        life; and 4) find the treatment to be highly tolerable.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in depression symptoms</measure>
      <time_frame>6 weeks</time_frame>
      <description>Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9). Scores on this scale range from 0-27, with higher scores indication more severe depression.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in anxiety symptoms</measure>
      <time_frame>6 weeks</time_frame>
      <description>Change in anxiety symptoms based on the Overall Anxiety Severity and Impairment Scale (OASIS). Scores on this scale range from 0-20, with higher scores indication more severe anxiety.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in PTSD symptoms</measure>
      <time_frame>6 weeks</time_frame>
      <description>Change in PTSD symptom severity based on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Scores on this scale range from 0-80 with higher scores indicating greater symptom severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in positive and negative affect</measure>
      <time_frame>6 weeks</time_frame>
      <description>Change in positive and negative affect based on the Positive and Negative Affect Schedule (PANAS). Scores on the two subscales of this assessment range from 0-50, with higher scores on the positive affect subscale representing higher levels of positive affect, and lower scores on the negative affect subscale representing lower levels of negative affect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life</measure>
      <time_frame>6 weeks</time_frame>
      <description>Change in quality of life as measure by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). Scores on this scale range from 0-70, and are converted to a percentage, with higher scores indicating greater life enjoyment and satisfaction.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychotherapy progress</measure>
      <time_frame>6 weeks</time_frame>
      <description>Psychotherapy progress as measured by the Outcome Questionnaire 45 (OQ-45). A total score of all subscales ranges from 0 to 180, with higher scores indicating more severe distress and functional impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment acceptability</measure>
      <time_frame>6 weeks</time_frame>
      <description>Acceptability of the treatment program based on responses to a Treatment Acceptability Questionnaire. Scores on this questionnaire range from 5-30 with higher scores indicating greater acceptability.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">65</enrollment>
    <condition>Anhedonia</condition>
    <arm_group>
      <arm_group_label>PVSET</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive a course of individual therapy through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre. Therapy will consist of a validated treatment protocol known as Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Therapy sessions will be facilitated by psychologists, licensed therapists (e.g., MSW, RPN), and/or graduate students in psychology under supervision at the OSIC. PVSET will consist of 6 sessions, each lasting one hour, and will be delivered either virtually or in-person at OSIC depending on patient preference.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PVSET</intervention_name>
      <description>6, one-hour sessions of individual therapy, consisting of Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.</description>
      <arm_group_label>PVSET</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Be an actively serving or veteran member of the CAF and RCMP;&#xD;
  &#xD;
            -  Have been referred to receive the treatment protocol at the OSIC at Deer Lodge Centre&#xD;
               by a doctor or psychologist;&#xD;
  &#xD;
            -  Have previously participated in at least one evidence-based psychological treatment&#xD;
               for depressive, anxiety, or trauma-and-stressor-related condition at OSIC but remain&#xD;
               clinically symptomatic;&#xD;
  &#xD;
            -  Be able to speak, read, and write in English;&#xD;
  &#xD;
            -  Have no current psychosis, untreated bipolar disorder, or current suicidal ideation&#xD;
               with plan and intent;&#xD;
  &#xD;
            -  Be on a stable medication regime and agree to not make changes for the duration of the&#xD;
               treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Deer Lodge Centre</name>
        <address>
          <city>Winnipeg</city>
          <state>Manitoba</state>
          <zip>R3J 0L3</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manitoba</investigator_affiliation>
      <investigator_full_name>Kevin Barber</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anhedonia</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/NCT06035562
  org study id: HS26055 (H2023:201)
  nct id: NCT06035562
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will examine whether actively serving and veteran members of the Canadian Armed
        Forces (CAF) and Royal Canadian Mounted Police (RCMP) who complete a treatment targeting
        anhedonia symptoms and amplifying positive emotional processing: 1) experience significant
        symptom reductions in anxiety, trauma, and depressive symptoms; 2) report increased
        experience of positive emotions; 3) report improvements to broad functioning and quality of
        life; and 4) find the treatment to be highly tolerable.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in depression symptoms
  time frame: 6 weeks
  description: Change in depression symptoms based on the Patient Health Questionnaire-9 (PHQ-9). Scores on this scale range from 0-27, with higher scores indication more severe depression.
  measure: Change in anxiety symptoms
  time frame: 6 weeks
  description: Change in anxiety symptoms based on the Overall Anxiety Severity and Impairment Scale (OASIS). Scores on this scale range from 0-20, with higher scores indication more severe anxiety.
  measure: Change in PTSD symptoms
  time frame: 6 weeks
  description: Change in PTSD symptom severity based on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5). Scores on this scale range from 0-80 with higher scores indicating greater symptom severity.
  measure: Change in positive and negative affect
  time frame: 6 weeks
  description: Change in positive and negative affect based on the Positive and Negative Affect Schedule (PANAS). Scores on the two subscales of this assessment range from 0-50, with higher scores on the positive affect subscale representing higher levels of positive affect, and lower scores on the negative affect subscale representing lower levels of negative affect.
  measure: Change in quality of life
  time frame: 6 weeks
  description: Change in quality of life as measure by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF). Scores on this scale range from 0-70, and are converted to a percentage, with higher scores indicating greater life enjoyment and satisfaction.
  measure: Psychotherapy progress
  time frame: 6 weeks
  description: Psychotherapy progress as measured by the Outcome Questionnaire 45 (OQ-45). A total score of all subscales ranges from 0 to 180, with higher scores indicating more severe distress and functional impairment.
  measure: Treatment acceptability
  time frame: 6 weeks
  description: Acceptability of the treatment program based on responses to a Treatment Acceptability Questionnaire. Scores on this questionnaire range from 5-30 with higher scores indicating greater acceptability.
  arm group label: PVSET
  arm group type: Experimental
  description: Participants will receive a course of individual therapy through the Operational Stress Injury Clinic (OSIC) at Deer Lodge Centre. Therapy will consist of a validated treatment protocol known as Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Therapy sessions will be facilitated by psychologists, licensed therapists (e.g., MSW, RPN), and/or graduate students in psychology under supervision at the OSIC. PVSET will consist of 6 sessions, each lasting one hour, and will be delivered either virtually or in-person at OSIC depending on patient preference.
  intervention type: Behavioral
  intervention name: PVSET
  description: 6, one-hour sessions of individual therapy, consisting of Positive Valence System Enhancement Treatment for Anxiety and Depression (PVSET), which will consist of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors.
  arm group label: PVSET
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Manitoba
  investigator full name: Kevin Barber
  investigator title: Principal Investigator
  mesh term: Anhedonia
  sharing ipd: No