<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/NCT03821259</url>
  </required_header>
  <id_info>
    <org_study_id>CAHSS1802/04</org_study_id>
    <nct_id>NCT03821259</nct_id>
  </id_info>
  <brief_title>Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life</brief_title>
  <official_title>Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Edinburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NHS Tayside</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Edinburgh</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>
      Older adults are becoming a growing proportion of people utilising mental health services.&#xD;
      However, the needs of this population are poorly understood despite the evidence that mental&#xD;
      health conditions are manifested differently in old age. One of those conditions is Post&#xD;
      Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse&#xD;
      outcomes in old age, including health problems, difficulties in daily functioning, less&#xD;
      satisfaction with life and multiple psychiatric co-morbidities, such as depression and&#xD;
      anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported&#xD;
      or misperceived as a physical illness or part of an ageing process.&#xD;
&#xD;
      Traumatic life experiences do not necessarily lead to PTSD. Psychological resources,&#xD;
      including emotional stability and social support, allow individuals to find appropriate&#xD;
      coping strategies and maintain well-being in old age. Group identification, defined as a&#xD;
      sense of belonging to a specific group, influences the response to social support and may be&#xD;
      important in predicting distress in old age. On the other hand, socioeconomic deprivation is&#xD;
      likely to increase this distress as exposure to traumatic events is more prevalent in&#xD;
      disadvantaged populations.&#xD;
&#xD;
      The present study will investigate the impact of those factors on PTSD symptoms in later&#xD;
      life. The researcher will recruit 85 older adults from the Older People Psychological&#xD;
      Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or&#xD;
      depression. Participants will be asked to provide basic demographic information, which will&#xD;
      be used to describe the participant characteristics and to estimate the degree of&#xD;
      socioeconomic deprivation. Participants will also complete five measures to screen for&#xD;
      cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation&#xD;
      and group identification.&#xD;
&#xD;
      The findings will help improve the diagnostic process and development of psychological&#xD;
      treatments for PTSD in older adults by expanding our knowledge of this condition in later&#xD;
      life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim of the study:&#xD;
&#xD;
      To investigate the importance and relative contribution of interpersonal and intra-individual&#xD;
      factors, including lifetime trauma exposure, emotion regulation, social group belonging and&#xD;
      socioeconomic deprivation in predicting PTSD symptoms in older adults.&#xD;
&#xD;
      Primary research questions:&#xD;
&#xD;
        1. Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older&#xD;
           adults?&#xD;
&#xD;
        2. Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms&#xD;
           in older adults?&#xD;
&#xD;
        3. Will a lower number of group identifications predict higher levels of PTSD symptoms in&#xD;
           older adults?&#xD;
&#xD;
        4. Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms&#xD;
           in older adults?&#xD;
&#xD;
      Secondary research questions:&#xD;
&#xD;
        1. What is the relative contribution of lifetime trauma exposure in predicting levels of&#xD;
           PTSD symptoms in older adults?&#xD;
&#xD;
        2. What is the relative contribution of difficulties in emotion regulation in predicting&#xD;
           levels of PTSD symptoms in older adults?&#xD;
&#xD;
        3. What is the relative contribution of group identifications in predicting levels of PTSD&#xD;
           symptoms in older adults?&#xD;
&#xD;
        4. What is the relative contribution of socioeconomic deprivation in predicting levels of&#xD;
           PTSD symptoms in older adults?&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The study will employ a cross-sectional, within-groups design. An opportunistic clinical&#xD;
      sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD,&#xD;
      anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will&#xD;
      be recruited. Participants will be asked to provide basic demographic information and to&#xD;
      complete five measures, screening for cognitive impermanent and measuring PTSD symptoms,&#xD;
      lifetime trauma exposure, emotion regulation and group identification. Correlation and&#xD;
      multiple regression analyses will be used to answer the research hypotheses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Actual">May 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Trauma History Questionnaire (THQ; Green, 1996)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Difficulties in Emotion Regulation Scale (DERS; Gratz &amp; Roemer, 2004)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska &amp; Keane, 1994)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Group Identification Scale (GIS; Sani et al., 2012)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. &quot;I have a sense of belonging to [my group]&quot;. Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)</measure>
    <time_frame>through study completion, an average of 6 months</time_frame>
    <description>The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Older adults with mental health history</arm_group_label>
    <description>Eligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Psychological measures</intervention_name>
    <description>Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.</description>
    <arm_group_label>Older adults with mental health history</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        An opportunistic clinical sample of older adults, aged 65 and over, in receipt of&#xD;
        psychological treatment for PTSD, anxiety or depression in the Older People Psychological&#xD;
        Therapies Service in NHS Tayside will be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 65 years and over&#xD;
&#xD;
          -  In receipt of psychological treatment for PTSD, anxiety or depression&#xD;
&#xD;
          -  Fluent English speaker&#xD;
&#xD;
          -  Ability to give consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment (MoCA ≤20)&#xD;
&#xD;
          -  Under investigation for or a confirmed diagnosis of dementia&#xD;
&#xD;
          -  Currently experiencing an episode of a serious mental illness, e.g. psychosis&#xD;
&#xD;
          -  Ongoing substance misuse&#xD;
&#xD;
          -  Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaudia Suchorab, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>NHS Tayside/University of Edinburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tayside Older People Psychological Therapies service</name>
      <address>
        <city>Dundee</city>
        <zip>DD2 3PT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <results_first_submitted>October 7, 2019</results_first_submitted>
  <results_first_submitted_qc>June 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">June 23, 2020</results_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03821259/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>The study recruited an opportunistic sample of suitable participants who were identified and initially approached about the study by a psychologist involved in their care. Consequently no participants were excluded following their enrolment in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Older Adults With Mental Health History</title>
          <description>Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Older Adults With Mental Health History</title>
          <description>Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="88"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72.17" spread="4.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>The Civilian Version of the PTSD Checklist (PCL-C)</title>
          <description>The Civilian Version of the PTSD Checklist (PCL-C; Blanchard, Jones-Alexander, Buckley, &amp; Forneris, 1996; Weathers, Litz, Herman, Huska, &amp; Keane, 1993) measures PTSD symptoms in the civilian population. Participants answered 17 items by rating levels of distress caused by each symptom in the past month on a 5-point scale (1 = not at all to 5 = extremely). Total scores range from 17 to 85. Higher scores indicate greater symptom severity.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="88"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.14" spread="14.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Trauma History Questionnaire (THQ; Green, 1996)</title>
        <description>This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.</description>
        <time_frame>through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Older Adults With Mental Health History</title>
            <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
          </group>
        </group_list>
        <measure>
          <title>The Trauma History Questionnaire (THQ; Green, 1996)</title>
          <description>This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total number of traumatic events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.93" spread="3.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Crime-related events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.76" spread="0.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>General trauma and disasters</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="2.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unwanted sexual experiences and physical violence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.97" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Difficulties in Emotion Regulation Scale (DERS; Gratz &amp; Roemer, 2004)</title>
        <description>This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.</description>
        <time_frame>through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Older Adults With Mental Health History</title>
            <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
          </group>
        </group_list>
        <measure>
          <title>The Difficulties in Emotion Regulation Scale (DERS; Gratz &amp; Roemer, 2004)</title>
          <description>This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DERS total score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.63" spread="24.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acceptance of emotional responses</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.20" spread="6.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Engagement in goal-directed behaviours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.59" spread="4.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Impulse control</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.26" spread="5.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.56" spread="4.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Access to emotion regulation strategies</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.51" spread="7.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional clarity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.51" spread="4.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska &amp; Keane, 1994)</title>
        <description>This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.</description>
        <time_frame>through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Older Adults With Mental Health History</title>
            <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
          </group>
        </group_list>
        <measure>
          <title>The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska &amp; Keane, 1994)</title>
          <description>This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.14" spread="14.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Group Identification Scale (GIS; Sani et al., 2012)</title>
        <description>This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. &quot;I have a sense of belonging to [my group]&quot;. Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.</description>
        <time_frame>through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Older Adults With Mental Health History</title>
            <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
          </group>
        </group_list>
        <measure>
          <title>The Group Identification Scale (GIS; Sani et al., 2012)</title>
          <description>This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. &quot;I have a sense of belonging to [my group]&quot;. Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.</description>
          <units>Number of groups participants identified</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.73" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)</title>
        <description>The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).</description>
        <time_frame>through study completion, an average of 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Older Adults With Mental Health History</title>
            <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
          </group>
        </group_list>
        <measure>
          <title>The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)</title>
          <description>The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Older Adults With Mental Health History</title>
          <description>Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="88"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Klaudia Suchorab</name_or_title>
      <organization>University of Edinburgh/NHS Tayside</organization>
      <phone>+44 1738 621151</phone>
      <email>klaudia.suchorab@nhs.net</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03821259
org study id: CAHSS1802/04
nct id: NCT03821259
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Older adults are becoming a growing proportion of people utilising mental health services.
      However, the needs of this population are poorly understood despite the evidence that mental
      health conditions are manifested differently in old age. One of those conditions is Post
      Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse
      outcomes in old age, including health problems, difficulties in daily functioning, less
      satisfaction with life and multiple psychiatric co-morbidities, such as depression and
      anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported
      or misperceived as a physical illness or part of an ageing process.

      Traumatic life experiences do not necessarily lead to PTSD. Psychological resources,
      including emotional stability and social support, allow individuals to find appropriate
      coping strategies and maintain well-being in old age. Group identification, defined as a
      sense of belonging to a specific group, influences the response to social support and may be
      important in predicting distress in old age. On the other hand, socioeconomic deprivation is
      likely to increase this distress as exposure to traumatic events is more prevalent in
      disadvantaged populations.

      The present study will investigate the impact of those factors on PTSD symptoms in later
      life. The researcher will recruit 85 older adults from the Older People Psychological
      Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or
      depression. Participants will be asked to provide basic demographic information, which will
      be used to describe the participant characteristics and to estimate the degree of
      socioeconomic deprivation. Participants will also complete five measures to screen for
      cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation
      and group identification.

      The findings will help improve the diagnostic process and development of psychological
      treatments for PTSD in older adults by expanding our knowledge of this condition in later
      life.
Aim of the study:

      To investigate the importance and relative contribution of interpersonal and intra-individual
      factors, including lifetime trauma exposure, emotion regulation, social group belonging and
      socioeconomic deprivation in predicting PTSD symptoms in older adults.

      Primary research questions:

        1. Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older
           adults?

        2. Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms
           in older adults?

        3. Will a lower number of group identifications predict higher levels of PTSD symptoms in
           older adults?

        4. Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms
           in older adults?

      Secondary research questions:

        1. What is the relative contribution of lifetime trauma exposure in predicting levels of
           PTSD symptoms in older adults?

        2. What is the relative contribution of difficulties in emotion regulation in predicting
           levels of PTSD symptoms in older adults?

        3. What is the relative contribution of group identifications in predicting levels of PTSD
           symptoms in older adults?

        4. What is the relative contribution of socioeconomic deprivation in predicting levels of
           PTSD symptoms in older adults?

      Design:

      The study will employ a cross-sectional, within-groups design. An opportunistic clinical
      sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD,
      anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will
      be recruited. Participants will be asked to provide basic demographic information and to
      complete five measures, screening for cognitive impermanent and measuring PTSD symptoms,
      lifetime trauma exposure, emotion regulation and group identification. Correlation and
      multiple regression analyses will be used to answer the research hypotheses.
observational model: Case-Only
time perspective: Cross-Sectional
measure: The Trauma History Questionnaire (THQ; Green, 1996)
time frame: through study completion, an average of 6 months
description: This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.
measure: The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
time frame: through study completion, an average of 6 months
description: This questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.
measure: The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)
time frame: through study completion, an average of 6 months
description: This questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.
measure: The Group Identification Scale (GIS; Sani et al., 2012)
time frame: through study completion, an average of 6 months
description: This questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to [my group]". Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.
measure: The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)
time frame: through study completion, an average of 6 months
description: The SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).
arm group label: Older adults with mental health history
description: Eligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service.
intervention type: Other
intervention name: Psychological measures
description: Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
arm group label: Older adults with mental health history
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Klaudia Suchorab, MSc
role: Principal Investigator
affiliation: NHS Tayside/University of Edinburgh
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 