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/NCT05993468</url>
    </required_header>
    <id_info>
      <org_study_id>Trauma Outpatient Unit</org_study_id>
      <nct_id>NCT05993468</nct_id>
    </id_info>
    <brief_title>A Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention</brief_title>
    <official_title>A Mixed-Methods Pilot Study of a Trauma-Sensitive Mindfulness and Compassion Intervention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Modum Bad</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Modum Bad</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 mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress&#xD;
        disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms,&#xD;
        self-critique, and self-compassion following participation in a 16-week trauma-sensitive&#xD;
        mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also&#xD;
        explored explicitly.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Seventeen clients most female with severe childhood abuse and PTSD and CPTSD participated in&#xD;
        the TMC intervention. A mixed-methods design was used. All clients completed questionnaires&#xD;
        before (pre) and after (post) the intervention to gain information on symptom change,&#xD;
        self-critique, and self-compassion. Second, a qualitative interview addressing clients'&#xD;
        experiences of participation, including an explicit focus on adverse experiences, was&#xD;
        conducted.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2019</start_date>
    <completion_date type="Actual">March 1, 2023</completion_date>
    <primary_completion_date type="Actual">January 1, 2020</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>PTSD Checklist for Diagnostic Statistical Manual (DSM) -5</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>The Posttraumatic checklist (PCL-5) is a measure of perceived PTSD symptom severity in the past month. It was used to assess the likelihood of a PTSD diagnosis given 20 symptom descriptions (items) reflecting the DSM-5 criteria. Clients rated the extent to which they were troubled by PTSD symptoms on a 5-point Likert-type scale (0 for &quot;Not at all&quot; to 4 for &quot;Extremely&quot;).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The International Trauma Questionnaire (ITQ)</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>A 17-item self-report measure of ICD-11 PTSD and CPTSD were used to assess the CPTSD symptoms. Clients rated the extent to which they were troubled by CPTSD symptoms in the previous one month period on a 5-point Likert-type scale (0 for &quot;Not at all to 4 for &quot;Extremely&quot;), reflecting the three clusters of disturbances in self-organization (DSO) in CPTSD (affective dysregulation, negative self-concept, and disturbances in relationships).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trauma-Related Altered States of Consciousness (TRASC):</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>A 10-item self-report measure was used to survey a spectrum of dissociative experiences. Clients rated the extent to which they were troubled by TRASC symptoms on a 5-point Likert-type scale (0 for &quot;Not at all&quot; to 4 for &quot;Extremely&quot;). A total score was calculated across the items 1, 3, 5, 6, and 10 . Two items assessed depersonalization and derealization as in the Dissociative-PTSD subtype and the other items assessed the phenomenology of TRASC more broadly in reference to the subjective dimensions of time, thought, body, and emotion as per the 4-D model of trauma-related dissociation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder-7 (GAD-7)</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>This symptom assessment tool measures anxiety with seven items in GAD-7 on a 4-point scale that assesses the impact on daily life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 (PHQ 9)</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>This symptom assessment tool measures depression with nine items in PHQ-9 on a 4-point scale that assesses the impact on daily life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-Compassion Scale (SCS)</measure>
      <time_frame>Change from pre-treatment to immediately after the intervention</time_frame>
      <description>The 26-item SCS consists of three positive subscales, namely Self-Kindness (5 items), Common Humanity (4 items), and Mindfulness (4 items) and three negative subscales, namely Self-Judgment (5 items), Isolation (4 items), and Over-Identification (4 items). Respondents rate their agreement with items on a 5-point Likert-type scale from &quot;Almost always&quot; (5) to &quot;Almost never&quot; (1).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">17</enrollment>
    <condition>Complex Post-Traumatic Stress Disorder</condition>
    <arm_group>
      <arm_group_label>TMC - group 1</arm_group_label>
      <description>TMC - group 1 was a closed group treated at a specialized outpatient facility for adult clients with CPTSD and complex dissociative disorders. Group 1 was led by two clinical psychologists</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TMC - group 2</arm_group_label>
      <description>TMC - group 2 was connected to specialized mental health services, but the intervention itself was carried out at a community centre. The community centre has collaborated with the District Psychiatric Centre (DPS) for many years, hosting an TMC group open to anyone attending the community centre in addition to clients connected to the DPS. This open concept was continued through the study intervention, but only clients connected to the DPS were included in the study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TMC Treatment Approach</intervention_name>
      <description>The TMC approach consists of 16 weekly group sessions, each lasting 2 hours. The first 10 sessions focus mainly on building mindfulness capacities, and the last 6 sessions on developing compassion toward self and others. Between sessions, participants are encouraged to do exercises with the support of audio files. The approach was developed with a transdiagnostic perspective, including clients with a variety of trauma-related symptoms.</description>
      <arm_group_label>TMC - group 1</arm_group_label>
      <arm_group_label>TMC - group 2</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The inclusion criteria in each group were in accordance with the institution's clinical&#xD;
          practice&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  report traumatic experiences and trauma related symptoms&#xD;
  &#xD;
            -  be between 18 and 65 years of age&#xD;
  &#xD;
            -  give informed consent to participate in the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  acute suicidality&#xD;
  &#xD;
            -  serious psychotic symptoms&#xD;
  &#xD;
            -  substance abuse interfering with treatment&#xD;
  &#xD;
            -  crisis interfering with treatment&#xD;
  &#xD;
            -  violent behavior&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Modum Bad</name>
        <address>
          <city>Vikersund</city>
          <zip>3371</zip>
          <country>Norway</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Norway</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Modum Bad</investigator_affiliation>
      <investigator_full_name>KAVrabel</investigator_full_name>
      <investigator_title>Research director</investigator_title>
    </responsible_party>
    <keyword>mindfullness</keyword>
    <keyword>treatment</keyword>
    <keyword>compassion</keyword>
    <keyword>trauma</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>Yes</sharing_ipd>
      <ipd_description>The ethical approval granted by the Regional Committees for Medical and Health Research Ethics in Norway (REK and NSD) and in accordance with the information given to the participants in the informed consent form regarding the use of data, does not allow the authors to submit the data to a public repository. In line with the ethics approval, the data are to be kept at a secure server only accessible by the authors of this study. Access to the data can be granted following ethical approval of suggested project plan for the use of data from Modum Bad. The data will then be anonymized and further stored at a secure system. Such requests are to be sent to research leader, KariAnne Vrabel, Modum Bad, email: karianne.vrabel@modum-bad.no.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>It is already available at a secure server at modum bad. Hopefully, it will be published within next fall, 2023</ipd_time_frame>
      <ipd_access_criteria>Placing the results of studies in a broader context: (for example, meta-analysis) Using the data as a convenience sample to address issues different from our research objectives Collaborating directly with other researchers where data need to be transferred to an alternative location for planned analyses connection of individual outcomes</ipd_access_criteria>
    </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/NCT05993468
  org study id: Trauma Outpatient Unit
  nct id: NCT05993468
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This mixed-methods pilot study aim to assess the changes in symptoms of post-traumatic stress
        disorder (PTSD), complex post-traumatic stress disorder (CPTSD), dissociative symptoms,
        self-critique, and self-compassion following participation in a 16-week trauma-sensitive
        mindfulness and compassion (TMC) intervention. Adverse experiences of participation are also
        explored explicitly.
  Seventeen clients most female with severe childhood abuse and PTSD and CPTSD participated in
        the TMC intervention. A mixed-methods design was used. All clients completed questionnaires
        before (pre) and after (post) the intervention to gain information on symptom change,
        self-critique, and self-compassion. Second, a qualitative interview addressing clients'
        experiences of participation, including an explicit focus on adverse experiences, was
        conducted.
  observational model: Cohort
  time perspective: Prospective
  measure: PTSD Checklist for Diagnostic Statistical Manual (DSM) -5
  time frame: Change from pre-treatment to immediately after the intervention
  description: The Posttraumatic checklist (PCL-5) is a measure of perceived PTSD symptom severity in the past month. It was used to assess the likelihood of a PTSD diagnosis given 20 symptom descriptions (items) reflecting the DSM-5 criteria. Clients rated the extent to which they were troubled by PTSD symptoms on a 5-point Likert-type scale (0 for "Not at all" to 4 for "Extremely").
  measure: The International Trauma Questionnaire (ITQ)
  time frame: Change from pre-treatment to immediately after the intervention
  description: A 17-item self-report measure of ICD-11 PTSD and CPTSD were used to assess the CPTSD symptoms. Clients rated the extent to which they were troubled by CPTSD symptoms in the previous one month period on a 5-point Likert-type scale (0 for "Not at all to 4 for "Extremely"), reflecting the three clusters of disturbances in self-organization (DSO) in CPTSD (affective dysregulation, negative self-concept, and disturbances in relationships).
  measure: Trauma-Related Altered States of Consciousness (TRASC):
  time frame: Change from pre-treatment to immediately after the intervention
  description: A 10-item self-report measure was used to survey a spectrum of dissociative experiences. Clients rated the extent to which they were troubled by TRASC symptoms on a 5-point Likert-type scale (0 for "Not at all" to 4 for "Extremely"). A total score was calculated across the items 1, 3, 5, 6, and 10 . Two items assessed depersonalization and derealization as in the Dissociative-PTSD subtype and the other items assessed the phenomenology of TRASC more broadly in reference to the subjective dimensions of time, thought, body, and emotion as per the 4-D model of trauma-related dissociation
  measure: General Anxiety Disorder-7 (GAD-7)
  time frame: Change from pre-treatment to immediately after the intervention
  description: This symptom assessment tool measures anxiety with seven items in GAD-7 on a 4-point scale that assesses the impact on daily life.
  measure: Patient Health Questionnaire-9 (PHQ 9)
  time frame: Change from pre-treatment to immediately after the intervention
  description: This symptom assessment tool measures depression with nine items in PHQ-9 on a 4-point scale that assesses the impact on daily life.
  measure: Self-Compassion Scale (SCS)
  time frame: Change from pre-treatment to immediately after the intervention
  description: The 26-item SCS consists of three positive subscales, namely Self-Kindness (5 items), Common Humanity (4 items), and Mindfulness (4 items) and three negative subscales, namely Self-Judgment (5 items), Isolation (4 items), and Over-Identification (4 items). Respondents rate their agreement with items on a 5-point Likert-type scale from "Almost always" (5) to "Almost never" (1).
  arm group label: TMC - group 1
  description: TMC - group 1 was a closed group treated at a specialized outpatient facility for adult clients with CPTSD and complex dissociative disorders. Group 1 was led by two clinical psychologists
  arm group label: TMC - group 2
  description: TMC - group 2 was connected to specialized mental health services, but the intervention itself was carried out at a community centre. The community centre has collaborated with the District Psychiatric Centre (DPS) for many years, hosting an TMC group open to anyone attending the community centre in addition to clients connected to the DPS. This open concept was continued through the study intervention, but only clients connected to the DPS were included in the study.
  intervention type: Other
  intervention name: TMC Treatment Approach
  description: The TMC approach consists of 16 weekly group sessions, each lasting 2 hours. The first 10 sessions focus mainly on building mindfulness capacities, and the last 6 sessions on developing compassion toward self and others. Between sessions, participants are encouraged to do exercises with the support of audio files. The approach was developed with a transdiagnostic perspective, including clients with a variety of trauma-related symptoms.
  arm group label: TMC - group 1
  arm group label: TMC - group 2
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: Norway
  responsible party type: Principal Investigator
  investigator affiliation: Modum Bad
  investigator full name: KAVrabel
  investigator title: Research director
  mesh term: Stress Disorders, Traumatic
  mesh term: Stress Disorders, Post-Traumatic
  sharing ipd: Yes
  ipd description: The ethical approval granted by the Regional Committees for Medical and Health Research Ethics in Norway (REK and NSD) and in accordance with the information given to the participants in the informed consent form regarding the use of data, does not allow the authors to submit the data to a public repository. In line with the ethics approval, the data are to be kept at a secure server only accessible by the authors of this study. Access to the data can be granted following ethical approval of suggested project plan for the use of data from Modum Bad. The data will then be anonymized and further stored at a secure system. Such requests are to be sent to research leader, KariAnne Vrabel, Modum Bad, email: karianne.vrabel@modum-bad.no.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: It is already available at a secure server at modum bad. Hopefully, it will be published within next fall, 2023
  ipd access criteria: Placing the results of studies in a broader context: (for example, meta-analysis) Using the data as a convenience sample to address issues different from our research objectives Collaborating directly with other researchers where data need to be transferred to an alternative location for planned analyses connection of individual outcomes