<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/NCT03807193</url>
  </required_header>
  <id_info>
    <org_study_id>worry factorial</org_study_id>
    <nct_id>NCT03807193</nct_id>
  </id_info>
  <brief_title>Self-selected or Predetermined Internet-based Treatment for Generalized Anxiety Disorder With Different Types of Support</brief_title>
  <official_title>Self-selected or Predetermined Internet-based Cognitive Behavior Therapy for Generalized Anxiety Disorder With Weekly Support or Support on Demand: A Factorial Treatment Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
      This study evaluates two types of internet-based treatments for generalized anxiety disorder&#xD;
      and two types of support. The treatments are a predetermined program for generalized anxiety&#xD;
      disorder and a self-selected treatment. The different types of support are either a weekly&#xD;
      contact trough a secure message system or support on demand.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Generalized anxiety disorder (GAD) is characterize by and excessive and uncontrollable worry&#xD;
      that is present more days than not. The disorder is best described as a chronic condition&#xD;
      with periods with more or less symptoms. The disorder is highly disabling with low quality of&#xD;
      life for the individual and is associated with and high costs for society. Previous studies&#xD;
      on internet-based cognitive behavior therapy for GAD has shown positive effects but there are&#xD;
      still room for improvement.&#xD;
&#xD;
      The aim of this study is to evaluate two different internet-based treatments as well as two&#xD;
      types of support through the use of a factorial design. The participants will be recruited&#xD;
      trough advertising. After registration on the study's website the potential participants will&#xD;
      be asked to answer screening questionnaires and demographic data for an initial screening.&#xD;
      Those meeting inclusion criteria will be contacted for a diagnostic interview based&#xD;
      Mini-International Neuropsychiatric Interview (M.I.N.I.). If meeting the study's inclusion&#xD;
      criteria and not the exclusion criteria the participant will be included in the study and&#xD;
      randomized to one of the four arms. The four arms are: Predetermined treatment program with&#xD;
      weekly support, Predetermined treatment program with support on demand, Self-selected&#xD;
      treatment with weekly support, Self-selected treatment with support on demand.&#xD;
&#xD;
      The predetermined treatment program is designed for treatment of worry and generalized&#xD;
      anxiety disorder. It is based on newer forms of cognitive behavior therapy and includes&#xD;
      mindfulness and acceptance. In the self-selected treatment the participants will select&#xD;
      treatment interventions with the help of a manual and encouraged to choose interventions that&#xD;
      they feel address their specific problems. The interventions that will be available are all&#xD;
      based on standard cognitive behavior therapy techniques. The weekly support will be scheduled&#xD;
      and delivered by clinical psychology students under supervision. This contact will be based&#xD;
      on reports from the participants on the weeks work with the program and exercises. The&#xD;
      support on demand will be also be delivered by clinical psychology students under&#xD;
      supervision. This support takes place if and when the participant ask for support. Treatment&#xD;
      will be 8 weeks long and both treatments will be delivered through the same platform. Contact&#xD;
      with the participants will be trough written messages on a secure platform.&#xD;
&#xD;
      After the eight weeks of treatment the participants will be asked to answer the same measures&#xD;
      as before the treatment as well as questions regarding how they experience the treatment.&#xD;
      Follow up data will be collected at later points.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 10, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>A factorial design with four cells:&#xD;
Cell one: Predetermined treatment program with weekly support Cell two: Predetermined treatment program with support on demand Cell three: Self-selected treatment program with weekly support Cell four: Self-selected treatment program with support on demand</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Penn State Worry Questionnaire (PSWQ)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment</time_frame>
    <description>Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Beck Anxiety Inventory (BAI)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment</time_frame>
    <description>Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression II Inventory (BDI-II)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and Action Questionnaire II (AAQ-II)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brunnsviken Brief Quality of life scale (BBQ)</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General self-efficacy scale</measure>
    <time_frame>Baseline, 8 weeks, 24 months and 36 months after treatment</time_frame>
    <description>Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Generalized Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Fixed treatment, weekly support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives a predetermined treatment program and have weekly support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fixed treatment, support on demand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives a predetermined treatment program and have access to support on demand.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selected treatment, weekly support</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select their own treatment material and have weekly support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Selected treatment, support on demand</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Select their own treatment material and have access to support on demand.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-selected treatment</intervention_name>
    <description>The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.</description>
    <arm_group_label>Selected treatment, support on demand</arm_group_label>
    <arm_group_label>Selected treatment, weekly support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Predetermined treatment</intervention_name>
    <description>The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.</description>
    <arm_group_label>Fixed treatment, support on demand</arm_group_label>
    <arm_group_label>Fixed treatment, weekly support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weekly support</intervention_name>
    <description>The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.</description>
    <arm_group_label>Fixed treatment, weekly support</arm_group_label>
    <arm_group_label>Selected treatment, weekly support</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Support on demand</intervention_name>
    <description>The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.</description>
    <arm_group_label>Fixed treatment, support on demand</arm_group_label>
    <arm_group_label>Selected treatment, support on demand</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  fulfilling criteria for generalized anxiety syndrome&#xD;
&#xD;
          -  45 points or more on PSWQ&#xD;
&#xD;
          -  Able to read and write in Swedish&#xD;
&#xD;
          -  Have daily access to a computer and internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Alcohol or substance abuse&#xD;
&#xD;
          -  Acute suicidal&#xD;
&#xD;
          -  Ongoing psychological treatment&#xD;
&#xD;
          -  Ongoing medication for anxiety or depression that is planned to be adjusted during the&#xD;
             time of the treatment given in the study&#xD;
&#xD;
          -  Complex psychiatric illness that highly disabling&#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, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Linkoeping University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Linköpings universitet</name>
      <address>
        <city>Linköping</city>
        <state>Östergötland</state>
        <zip>58183</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 8, 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>February 18, 2021</last_update_submitted>
  <last_update_submitted_qc>February 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</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>Worry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03807193
org study id: worry factorial
nct id: NCT03807193
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates two types of internet-based treatments for generalized anxiety disorder
      and two types of support. The treatments are a predetermined program for generalized anxiety
      disorder and a self-selected treatment. The different types of support are either a weekly
      contact trough a secure message system or support on demand.
Generalized anxiety disorder (GAD) is characterize by and excessive and uncontrollable worry
      that is present more days than not. The disorder is best described as a chronic condition
      with periods with more or less symptoms. The disorder is highly disabling with low quality of
      life for the individual and is associated with and high costs for society. Previous studies
      on internet-based cognitive behavior therapy for GAD has shown positive effects but there are
      still room for improvement.

      The aim of this study is to evaluate two different internet-based treatments as well as two
      types of support through the use of a factorial design. The participants will be recruited
      trough advertising. After registration on the study's website the potential participants will
      be asked to answer screening questionnaires and demographic data for an initial screening.
      Those meeting inclusion criteria will be contacted for a diagnostic interview based
      Mini-International Neuropsychiatric Interview (M.I.N.I.). If meeting the study's inclusion
      criteria and not the exclusion criteria the participant will be included in the study and
      randomized to one of the four arms. The four arms are: Predetermined treatment program with
      weekly support, Predetermined treatment program with support on demand, Self-selected
      treatment with weekly support, Self-selected treatment with support on demand.

      The predetermined treatment program is designed for treatment of worry and generalized
      anxiety disorder. It is based on newer forms of cognitive behavior therapy and includes
      mindfulness and acceptance. In the self-selected treatment the participants will select
      treatment interventions with the help of a manual and encouraged to choose interventions that
      they feel address their specific problems. The interventions that will be available are all
      based on standard cognitive behavior therapy techniques. The weekly support will be scheduled
      and delivered by clinical psychology students under supervision. This contact will be based
      on reports from the participants on the weeks work with the program and exercises. The
      support on demand will be also be delivered by clinical psychology students under
      supervision. This support takes place if and when the participant ask for support. Treatment
      will be 8 weeks long and both treatments will be delivered through the same platform. Contact
      with the participants will be trough written messages on a secure platform.

      After the eight weeks of treatment the participants will be asked to answer the same measures
      as before the treatment as well as questions regarding how they experience the treatment.
      Follow up data will be collected at later points.
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: A factorial design with four cells:
Cell one: Predetermined treatment program with weekly support Cell two: Predetermined treatment program with support on demand Cell three: Self-selected treatment program with weekly support Cell four: Self-selected treatment program with support on demand
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in Penn State Worry Questionnaire (PSWQ)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Measures symptoms severity of worry. 16 items, with score range 16-80. Higher score indicates worse symptoms
measure: Change from baseline in Generalized Anxiety Disorder Questionnaire IV (GAD-Q-IV)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Designed to capture the criteria for generalized anxiety disorder according to diagnostic and statistical manual of mental disorders (DSM), 9 items with score range 0-12. Higher scores indicate greater symptom severity
measure: Change from baseline in Generalized Anxiety Disorder-7 (GAD-7)
time frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
description: Screening measure for worry and anxiety symptoms. 7 items, score range 0-21. Higher scores indicate greater symptom severity
measure: Change from baseline in Beck Anxiety Inventory (BAI)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Measure of anxiety symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
measure: Change from baseline in Patient Health Questionnaire (PHQ-9)
time frame: baseline and weekly during 8 weeks treatment. 24 months and 36 months after treatment
description: Screening measure for depressive symptoms. 9 items with score range 0-27. Higher scores indicate greater symptom severity
measure: Beck Depression II Inventory (BDI-II)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Measure of severity of depressive symptoms. 21 items with score range 0-63. Higher scores indicate greater symptom severity
measure: Acceptance and Action Questionnaire II (AAQ-II)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Measure of psychological flexibility. 7 items with score range 7-49 with higher scores indicate lower psychological flexibility
measure: Brunnsviken Brief Quality of life scale (BBQ)
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: 12 items, measures the quality of life. 12 items with score 0-96. Higher score indicate higher quality of life
measure: General self-efficacy scale
time frame: Baseline, 8 weeks, 24 months and 36 months after treatment
description: Measure of percieved self-efficay. 10 items rated on a four-point Likert scale. Score range 10-40 with a higher score indicating a higher percieved self-efficacy.
arm group label: Fixed treatment, weekly support
arm group type: Experimental
description: Receives a predetermined treatment program and have weekly support.
arm group label: Fixed treatment, support on demand
arm group type: Experimental
description: Receives a predetermined treatment program and have access to support on demand.
arm group label: Selected treatment, weekly support
arm group type: Experimental
description: Select their own treatment material and have weekly support.
arm group label: Selected treatment, support on demand
arm group type: Experimental
description: Select their own treatment material and have access to support on demand.
intervention type: Behavioral
intervention name: Self-selected treatment
description: The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.
arm group label: Selected treatment, support on demand
arm group label: Selected treatment, weekly support
intervention type: Behavioral
intervention name: Predetermined treatment
description: The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.
arm group label: Fixed treatment, support on demand
arm group label: Fixed treatment, weekly support
intervention type: Behavioral
intervention name: Weekly support
description: The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.
arm group label: Fixed treatment, weekly support
arm group label: Selected treatment, weekly support
intervention type: Behavioral
intervention name: Support on demand
description: The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.
arm group label: Fixed treatment, support on demand
arm group label: Selected treatment, support on demand
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gerhard Andersson, Professor
role: Principal Investigator
affiliation: Linkoeping University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Gerhard Andersson
investigator title: Professor
mesh term: Anxiety Disorders
sharing ipd: Undecided