<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/NCT03807154</url>
  </required_header>
  <id_info>
    <org_study_id>SOLUS</org_study_id>
    <nct_id>NCT03807154</nct_id>
  </id_info>
  <brief_title>Guided Online Self-help for Loneliness</brief_title>
  <official_title>SOLUS - A Randomized Controlled Two-site Trial Comparing Internet-based Cognitive Behavioral Therapy and Internet-based Interpersonal Psychotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Linkoeping University</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>
      The study seeks to investigate the efficacy of two internet-based self-help programmes&#xD;
      administered with support from a therapist. The two active conditions consist of an internet&#xD;
      cognitive behavioral therapy (ICBT) programme and a intervention of internet-based&#xD;
      interpersonal psychotherapy (IIPT), both of which have been developed for the present study.&#xD;
      The active conditions will be compared to a wait-list control group.&#xD;
&#xD;
      Participants will be recruited in Sweden with a nationwide recruitment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">February 1, 2022</completion_date>
  <primary_completion_date type="Actual">February 1, 2022</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>Three conditions: Internet-based Cognitive behavioral therapy, Internet-based Interpersonal psychotherapy, and a wait-list during the primary treatment phase. The wait-list will be allocated to the two active conditions once the primary treatment phase has finished.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)</measure>
    <time_frame>During week 2, 4, 6, and 8 of the intervention, 10 weeks after start of intervention, 4 months after completion of intervention, 12 months after start of intervention.</time_frame>
    <description>Measure of loneliness, total score ranging from 20-80 (representing the sum of each of the 20 individual items). Lower scores represent less loneliness and a more favourable outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change on Brunnsviken Brief Quality of Life Scale (BBQ)</measure>
    <time_frame>10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up</time_frame>
    <description>Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up</time_frame>
    <description>Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Social Interaction Anxiety Scale (SIAS)</measure>
    <time_frame>10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up</time_frame>
    <description>Measure of social interaction anxiety, closely correlated with social anxiety disorder. The score on each of the 20 items are summed up. Possible range for the total sum between 0 and 80. Higher scores indicate a higher degree of social interaction anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on Generalised Anxiety Disorder 7-item scale (GAD-7)</measure>
    <time_frame>10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up</time_frame>
    <description>Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Loneliness</condition>
  <arm_group>
    <arm_group_label>Internet-based cognitive behavioral therapy (ICBT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A nine-week long ICBT intervention with therapist support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Internet-based Interpersonal Therapy (IIPT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A nine-week long intervention based in interpersonal psychotherapy with therapist support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait-list control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ICBT</intervention_name>
    <description>A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.</description>
    <arm_group_label>Internet-based cognitive behavioral therapy (ICBT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IPT</intervention_name>
    <description>A nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week).</description>
    <arm_group_label>Internet-based Interpersonal Therapy (IIPT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Frequent and distressing experiences of loneliness&#xD;
&#xD;
          -  Can speak, write, and read the primary language of the country in which they reside&#xD;
             (Sweden or the United Kingdom).&#xD;
&#xD;
          -  Have access to an internet connection and a computer/smart phone/tablet&#xD;
&#xD;
          -  Are prepared to participate in the study, regardless of the type of treatment they are&#xD;
             randomly assigned to.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Changes in dosage of psychopharmaceutic medication in the last three months prior to&#xD;
             the start of the study or a planned change during the initial treatment period.&#xD;
&#xD;
          -  Other ongoing psychotherapeutic treatment&#xD;
&#xD;
          -  Suicidal plans&#xD;
&#xD;
          -  A previously diagnosed personality syndrome&#xD;
&#xD;
          -  Ongoing substance abuse&#xD;
&#xD;
          -  Other acute treatment need related to a psychiatric disorder requiring attention from&#xD;
             a mental health professional (e.g. eating disorders such as anorexia nervosa).&#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>Gerhard Andersson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Behavioral Sciences and Learning, Linköping University</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>58183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <removed_countries>
    <country>United Kingdom</country>
  </removed_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Gerhard Andersson</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Loneliness</keyword>
  <keyword>ICBT</keyword>
  <keyword>Internet-based psychotherapy</keyword>
  <keyword>Cognitive behavioral therapy</keyword>
  <keyword>Interpersonal psychotherapy</keyword>
  <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/NCT03807154
org study id: SOLUS
nct id: NCT03807154
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study seeks to investigate the efficacy of two internet-based self-help programmes
      administered with support from a therapist. The two active conditions consist of an internet
      cognitive behavioral therapy (ICBT) programme and a intervention of internet-based
      interpersonal psychotherapy (IIPT), both of which have been developed for the present study.
      The active conditions will be compared to a wait-list control group.

      Participants will be recruited in Sweden with a nationwide recruitment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three conditions: Internet-based Cognitive behavioral therapy, Internet-based Interpersonal psychotherapy, and a wait-list during the primary treatment phase. The wait-list will be allocated to the two active conditions once the primary treatment phase has finished.
primary purpose: Treatment
masking: None (Open Label)
measure: Change on UCLA Loneliness Scale, Version 3 (UCLA-LS-3)
time frame: During week 2, 4, 6, and 8 of the intervention, 10 weeks after start of intervention, 4 months after completion of intervention, 12 months after start of intervention.
description: Measure of loneliness, total score ranging from 20-80 (representing the sum of each of the 20 individual items). Lower scores represent less loneliness and a more favourable outcome.
measure: Change on Brunnsviken Brief Quality of Life Scale (BBQ)
time frame: 10 weeks after start of intervention, at 4 month follow-up, 12 month follow-up
description: Measure of quality of life, total score ranging from 0 to 96 with a higher score indicating a higher quality of life. The scores of each of the six primary questions regarding perceived quality of life within an area of life are multiplied with the score of an item measuring the perceived importance of the area in question.
measure: Change on Patient Health Questionnaire (PHQ-9)
time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
description: Measure of depressive symptoms. Possible range for the total sum: 0 to 27 (created by summing up the score from each item). Clinical cut-offs for mild, moderate, moderately severe and severe major depressive disorder are considered to be 5, 10, 15, and 20 points.
measure: Change on Social Interaction Anxiety Scale (SIAS)
time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
description: Measure of social interaction anxiety, closely correlated with social anxiety disorder. The score on each of the 20 items are summed up. Possible range for the total sum between 0 and 80. Higher scores indicate a higher degree of social interaction anxiety.
measure: Change on Generalised Anxiety Disorder 7-item scale (GAD-7)
time frame: 10 weeks after start of intervention, at 4 month follow-up, at 12 month follow-up
description: Measure of symptoms of generalised anxiety disorder (GAD). Seven items, the score is interpreted by summing up the score from each individual item. Higher scores indicate more severe problems with worry and generalised anxiety. The total sum ranges from 0 to 21 with cut-offs of 5, 10, and 15 representing mild, moderate and severe generalised anxiety.
arm group label: Internet-based cognitive behavioral therapy (ICBT)
arm group type: Experimental
description: A nine-week long ICBT intervention with therapist support.
arm group label: Internet-based Interpersonal Therapy (IIPT)
arm group type: Experimental
description: A nine-week long intervention based in interpersonal psychotherapy with therapist support.
arm group label: Wait-list
arm group type: No Intervention
description: Wait-list control group
intervention type: Behavioral
intervention name: ICBT
description: A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.
arm group label: Internet-based cognitive behavioral therapy (ICBT)
intervention type: Behavioral
intervention name: IPT
description: A nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week).
arm group label: Internet-based Interpersonal Therapy (IIPT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gerhard Andersson, PhD
role: Principal Investigator
affiliation: Linkoeping University
facility: 
country: Sweden
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Gerhard Andersson
investigator title: Professor
sharing ipd: No