<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/NCT03839966</url>
  </required_header>
  <id_info>
    <org_study_id>2018.25994</org_study_id>
    <nct_id>NCT03839966</nct_id>
  </id_info>
  <brief_title>Computerized Intervention for Loneliness</brief_title>
  <official_title>Computerized Intervention for Loneliness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Florida State University</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 assesses whether a month long computerized interpretation bias modification&#xD;
      intervention will reduce levels of loneliness compared to a control treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study hopes to assess whether a month long interpretation bias modification intervention&#xD;
      will reduce levels of loneliness compared to a control treatment. Participants will be&#xD;
      randomized into an active treatment condition or a control treatment that involves a healthy&#xD;
      living and relaxation protocol. The investigators hypothesize that participants in the IBM&#xD;
      condition will have lower levels of negative interpretation bias and loneliness than those in&#xD;
      the healthy habits condition at post treatment and follow up. The investigators further&#xD;
      hypothesize that the effects of IBM on loneliness will be accounted for by changes in&#xD;
      interpretation bias.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">April 30, 2020</completion_date>
  <primary_completion_date type="Actual">April 30, 2020</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Participants will be randomized to receive one of two treatments</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participants will not know if they are receiving the active or control treatment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>UCLA Loneliness Scale (ULS)</measure>
    <time_frame>Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)</time_frame>
    <description>A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Multidimensional Scale of Perceived Social Support</measure>
    <time_frame>Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self-report scale that measures perceived levels of social support. Scores range from 12 to 84 with higher scores indicating higher levels of perceived social support. The three subscales (friends, family and significant other) all have a range of 4 to 28 with higher scores indicating higher levels of perceived social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Phobia inventory</measure>
    <time_frame>Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)</measure>
    <time_frame>Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies Depression Scale (CES-D)</measure>
    <time_frame>Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Needs Questionnaire (INQ)</measure>
    <time_frame>Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interpretations Questionnaire- Social Subscale (IQ-S)</measure>
    <time_frame>Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)</time_frame>
    <description>Self report measure of interpretation bias of ambiguous social situations. Scales range from 0-44 with higher scores indicating a higher level of negative interpretation bias in social situations.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Loneliness</condition>
  <arm_group>
    <arm_group_label>Active Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Interpretation Bias Modification for Loneliness</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy Habits Psychoeducation and Relaxation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interpretation Bias Modification for Loneliness</intervention_name>
    <description>Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard &amp; Amir, 2008 and Beard, Weisberg, &amp; Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.</description>
    <arm_group_label>Active Treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Habits Psychoeducation and Relaxation</intervention_name>
    <description>Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.</description>
    <arm_group_label>Control Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Score of &gt;48 on the UCLA Loneliness Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent psychotherapy for social anxiety or depression&#xD;
&#xD;
          -  Unstable psychotropic medication status (i.e. a change within the last month)&#xD;
&#xD;
          -  History of psychotic or (hypo)manic symptoms&#xD;
&#xD;
          -  Alcohol or other substance abuse or dependence within the last three months&#xD;
&#xD;
          -  Previous participation in a similar IBM study&#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>Florida State University, Department of Psychology</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Jesse Cougle</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03839966
org study id: 2018.25994
nct id: NCT03839966
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study assesses whether a month long computerized interpretation bias modification
      intervention will reduce levels of loneliness compared to a control treatment.
This study hopes to assess whether a month long interpretation bias modification intervention
      will reduce levels of loneliness compared to a control treatment. Participants will be
      randomized into an active treatment condition or a control treatment that involves a healthy
      living and relaxation protocol. The investigators hypothesize that participants in the IBM
      condition will have lower levels of negative interpretation bias and loneliness than those in
      the healthy habits condition at post treatment and follow up. The investigators further
      hypothesize that the effects of IBM on loneliness will be accounted for by changes in
      interpretation bias.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomized to receive one of two treatments
primary purpose: Treatment
masking: Single (Participant)
masking description: Participants will not know if they are receiving the active or control treatment.
measure: UCLA Loneliness Scale (ULS)
time frame: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)
description: A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
measure: Multidimensional Scale of Perceived Social Support
time frame: Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)
description: Self-report scale that measures perceived levels of social support. Scores range from 12 to 84 with higher scores indicating higher levels of perceived social support. The three subscales (friends, family and significant other) all have a range of 4 to 28 with higher scores indicating higher levels of perceived social support.
measure: Social Phobia inventory
time frame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
description: Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
measure: State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
time frame: Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
description: Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
measure: Center for Epidemiological Studies Depression Scale (CES-D)
time frame: Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
description: Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.
measure: Interpersonal Needs Questionnaire (INQ)
time frame: Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
description: Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.
measure: Interpretations Questionnaire- Social Subscale (IQ-S)
time frame: Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
description: Self report measure of interpretation bias of ambiguous social situations. Scales range from 0-44 with higher scores indicating a higher level of negative interpretation bias in social situations.
arm group label: Active Treatment
arm group type: Experimental
description: Interpretation Bias Modification for Loneliness
arm group label: Control Treatment
arm group type: Active Comparator
description: Healthy Habits Psychoeducation and Relaxation.
intervention type: Behavioral
intervention name: Interpretation Bias Modification for Loneliness
description: Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard & Amir, 2008 and Beard, Weisberg, & Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.
arm group label: Active Treatment
intervention type: Behavioral
intervention name: Healthy Habits Psychoeducation and Relaxation
description: Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.
arm group label: Control Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Jesse Cougle
investigator title: Associate Professor
sharing ipd: No