<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/NCT01694030</url>
  </required_header>
  <id_info>
    <org_study_id>University of Southampton: LO6</org_study_id>
    <nct_id>NCT01694030</nct_id>
  </id_info>
  <brief_title>Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study</brief_title>
  <official_title>Effects of Repeated Attachment Security Priming on Depressed Mood: a Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southampton</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southampton</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore whether asking participants to visualise a secure&#xD;
      attachment figure or a neutral event leads to differences in self-reported felt security or&#xD;
      depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep&#xD;
      a secure prime activated over 3 days via text message visualisation tasks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depressed Mood 1</measure>
    <time_frame>Depressed mood will be measured on day 7 of the study (immediately after lab primes)</time_frame>
    <description>Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, &amp; Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Felt Security 1</measure>
    <time_frame>Felt security will be measured on day 7 of the study (after initial lab primes)</time_frame>
    <description>To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, &amp; Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressed Mood 2</measure>
    <time_frame>Depressed mood will be measured on day 7 of the study (after 3 days of text primes)</time_frame>
    <description>Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, &amp; Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressed Mood 3</measure>
    <time_frame>Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).</time_frame>
    <description>Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, &amp; Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Felt Security 2</measure>
    <time_frame>Felt security will be measured on day 10 of the study (after 3 days of text primes)</time_frame>
    <description>Participants will complete a 16-item measure of Felt Security (Luke, Carnelley, &amp; Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Felt Security 3</measure>
    <time_frame>Felt security will be measured on day 11 of the study (24 hours after last text prime)</time_frame>
    <description>To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, &amp; Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Unipolar Depression</condition>
  <arm_group>
    <arm_group_label>Neutral Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the neutral (control) condition of the attachment security priming experiment will be asked to spend time visualising neutral events (e.g., supermarket shopping)for 3-10 minutes at a time.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Secure condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the attachment security priming condition will be asked to complete visualisation tasks where they think about a secure attachment figure for between 3 - 10 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Attachment security priming</intervention_name>
    <arm_group_label>Neutral Condition</arm_group_label>
    <arm_group_label>Secure condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Anxiety and depressive symptoms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -Bipolar disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Professor Baldwin</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southampton</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lorna Otway</last_name>
    <phone>447764985326</phone>
    <email>Lorna.Otway@soton.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>College Keep</name>
      <address>
        <city>Southampton</city>
        <state>Hants</state>
        <zip>SO14 3DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>David Baldwin</last_name>
      <email>D.S.Baldwin@soton.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Lorna Otway</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 24, 2012</last_update_submitted>
  <last_update_submitted_qc>September 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Attachment security priming</keyword>
  <keyword>depressed mood</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</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/NCT01694030
org study id: University of Southampton: LO6
nct id: NCT01694030
lead sponsor: 
has dmc: No
The purpose of this study is to explore whether asking participants to visualise a secure
      attachment figure or a neutral event leads to differences in self-reported felt security or
      depressed mood. Furthermore, the investigators aim to explore whether it is possible to keep
      a secure prime activated over 3 days via text message visualisation tasks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: Depressed Mood 1
time frame: Depressed mood will be measured on day 7 of the study (immediately after lab primes)
description: Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
measure: Felt Security 1
time frame: Felt security will be measured on day 7 of the study (after initial lab primes)
description: To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
measure: Depressed Mood 2
time frame: Depressed mood will be measured on day 7 of the study (after 3 days of text primes)
description: Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
measure: Depressed Mood 3
time frame: Depressed mood will be measured on day 11 of the study (24 hours after the last text prime).
description: Depressed mood will be measured using the depression and anxiety items from the Profile of Mood States (POMS: McNair, Lorr, & Droppleman, 1992), which equates to 24 items out of the original 65 on the POMS. Respondents use a 5-point Likert-type scale (0=Not at all, 4=Extremely) to rate the extent to which they have experienced various mood states over the past week. This questionnaire takes 5 minutes to complete.
measure: Felt Security 2
time frame: Felt security will be measured on day 10 of the study (after 3 days of text primes)
description: Participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
measure: Felt Security 3
time frame: Felt security will be measured on day 11 of the study (24 hours after last text prime)
description: To find out whether the experimental manipulation was successful, participants will complete a 16-item measure of Felt Security (Luke, Carnelley, & Sedikides, 2012). This scale consists of ten words relating to feelings of security, comfort and safety (e.g., loved, protected). Participants rate the extent to which the person or scenario in the visualisation task made them feel secure, by rating each item using a 6-point Likert-type scale (1=not at all, 6=very much). This measure takes 3 minutes to complete.
arm group label: Neutral Condition
arm group type: Experimental
description: Participants in the neutral (control) condition of the attachment security priming experiment will be asked to spend time visualising neutral events (e.g., supermarket shopping)for 3-10 minutes at a time.
arm group label: Secure condition
arm group type: Experimental
description: Participants in the attachment security priming condition will be asked to complete visualisation tasks where they think about a secure attachment figure for between 3 - 10 minutes.
intervention type: Other
intervention name: Attachment security priming
arm group label: Neutral Condition
arm group label: Secure condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Professor Baldwin
role: Principal Investigator
affiliation: University of Southampton
last name: Lorna Otway
phone: 447764985326
email: Lorna.Otway@soton.ac.uk
facility: 
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder