<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/NCT03024593</url>
  </required_header>
  <id_info>
    <org_study_id>C1-L</org_study_id>
    <nct_id>NCT03024593</nct_id>
  </id_info>
  <brief_title>An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety</brief_title>
  <official_title>An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety in a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Cologne</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <brief_summary>
    <textblock>
      The purpose of the current study is to examine the effects of health-related internet use on&#xD;
      affect, health anxiety and symptom severity in individuals with pathological levels of health&#xD;
      anxiety. The present randomized controlled study compares an online medical searching&#xD;
      condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus.&#xD;
      After an induction of health anxiety using the Autobiographical Emotional Memory Task the&#xD;
      participants in the searching condition go online and search for subjectively relevant health&#xD;
      information (external focus of attention). Individuals in the waiting (i.e. non-searching)&#xD;
      condition are requested to do nothing and not to distract themselves (internal focus of&#xD;
      attention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The internet is a popular method for obtaining information. Increasingly, it is also used to&#xD;
      answer medical and health related questions, because compared to other methods (e.g. going to&#xD;
      the library or visiting a doctor) it has a number of advantages to offer like low costs,&#xD;
      availability, easy accessibility, anonymity, and great diversity of information types and&#xD;
      sources. 60 to 80 percent of internet users search online for medical information. In this&#xD;
      context the term &quot;cyberchondria&quot; was coined in the media to describe the potentially&#xD;
      detrimental effects of this behavior. The first studies in this field using self-report&#xD;
      retrospective data showed that individuals with elevated levels of health anxiety seem to&#xD;
      make increased use of the internet for this purpose and it seems to maintain health anxiety&#xD;
      in the long-term. However, up until today little is known about the consequences of this&#xD;
      behavior and the maintaining mechanism.&#xD;
&#xD;
      This randomized controlled experimental study investigates the effects of health-related&#xD;
      internet use on affect, symptom severity and health anxiety in individuals with pathological&#xD;
      health anxiety. Participants will first undergo a baseline assessment. After that health&#xD;
      anxiety is induced using the Autobiographical Emotional Memory Task and participants complete&#xD;
      another assessment. Then participants are randomly assigned to either an online medical&#xD;
      searching condition (experimental group, EG) or a non-searching condition (control group, CG)&#xD;
      to manipulate attentional focus. The EG is requested to search online for health information&#xD;
      (external focus of attention), the CG is requested to do nothing and not to distract&#xD;
      themselves (internal focus of attention). Then another assessment is completed and the&#xD;
      treatment groups are compared regarding the effects on affect, symptom severity and health&#xD;
      anxiety. Besides examining these effects a further aim of this study is to identify the&#xD;
      underlying mechanism. Two possibilities are supposed: a) An increase of the variables of&#xD;
      interest due to health-related information or b) a decrease due to externalization.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <primary_completion_date type="Anticipated">September 2018</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>
    <primary_purpose>Basic Science</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Change of health anxiety before and after 8 minutes of health-related internet searching or waiting</measure>
    <time_frame>right before and after 8 minutes of health-related internet searching or waiting</time_frame>
    <description>self-created item</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of positive and negative affect before and after 8 minutes of health-related internet searching or waiting</measure>
    <time_frame>right before and after 8 minutes of health-related internet searching or waiting</time_frame>
    <description>Positive Affect Negative Affect Schedule - State (PANAS-State)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of symptom severity before and after 8 minutes of health-related internet searching or waiting</measure>
    <time_frame>right before and after 8 minutes of health-related internet searching or waiting</time_frame>
    <description>Checklist for symptoms in daily life (CSD)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of health anxiety before and after 10 minutes of anxiety induction</measure>
    <time_frame>right before and after 10 minutes of anxiety induction</time_frame>
    <description>self-created item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of positive and negative affect before and after 10 minutes of anxiety induction</measure>
    <time_frame>right before and after 10 minutes of anxiety induction</time_frame>
    <description>Positive Affect Negative Affect Schedule - State (PANAS-State)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of symptom severity before and after 10 minutes of anxiety induction</measure>
    <time_frame>right before and after 10 minutes of anxiety induction</time_frame>
    <description>Checklist for symptoms in daily life (CSD)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hypochondriasis</condition>
  <arm_group>
    <arm_group_label>Searching condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To simulate participants' natural behavior they are requested to search online for personally relevant health or illness information in their usual manner. By doing so their attentional focus lies on the searching process and the information they obtain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting condition (i.e. non- searching, no distraction)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are requested to do nothing and not to distract themselves by reading or using their smartphone for instance. By doing so, it is expected that their attentional focus lies on their induced worries and symptoms.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Health- and illness-related internet use</intervention_name>
    <arm_group_label>Searching condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological health anxiety according to the criteria of Fink et al. (2004)&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
          -  Sufficient German language skills&#xD;
&#xD;
          -  Sufficient skills using a computer, a smartphone and the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suicidal tendency&#xD;
&#xD;
          -  Clinical diagnosis of alcohol or drug abuse, acute schizophrenia&#xD;
&#xD;
          -  Organic brain disorders&#xD;
&#xD;
          -  Impairment of intelligence&#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>Michael Witthoeft, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sandra K Hamann, Dipl.-Psych.</last_name>
    <phone>(+49) 6131 - 3939 214</phone>
    <email>sahamann@uni-mainz.de</email>
  </overall_contact>
  <link>
    <url>https://www.blogs.uni-mainz.de/fb02-kp-pt-epp/forschung/cyberchondrie/</url>
    <description>Related Info</description>
  </link>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Sandra K. Hamann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cyberchondria</keyword>
  <keyword>health-related internet use</keyword>
  <keyword>pathological health anxiety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypochondriasis</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/NCT03024593
org study id: C1-L
nct id: NCT03024593
lead sponsor: 
collaborator: 
The purpose of the current study is to examine the effects of health-related internet use on
      affect, health anxiety and symptom severity in individuals with pathological levels of health
      anxiety. The present randomized controlled study compares an online medical searching
      condition with a waiting (i.e. non-searching) condition to manipulate the attentional focus.
      After an induction of health anxiety using the Autobiographical Emotional Memory Task the
      participants in the searching condition go online and search for subjectively relevant health
      information (external focus of attention). Individuals in the waiting (i.e. non-searching)
      condition are requested to do nothing and not to distract themselves (internal focus of
      attention).
The internet is a popular method for obtaining information. Increasingly, it is also used to
      answer medical and health related questions, because compared to other methods (e.g. going to
      the library or visiting a doctor) it has a number of advantages to offer like low costs,
      availability, easy accessibility, anonymity, and great diversity of information types and
      sources. 60 to 80 percent of internet users search online for medical information. In this
      context the term "cyberchondria" was coined in the media to describe the potentially
      detrimental effects of this behavior. The first studies in this field using self-report
      retrospective data showed that individuals with elevated levels of health anxiety seem to
      make increased use of the internet for this purpose and it seems to maintain health anxiety
      in the long-term. However, up until today little is known about the consequences of this
      behavior and the maintaining mechanism.

      This randomized controlled experimental study investigates the effects of health-related
      internet use on affect, symptom severity and health anxiety in individuals with pathological
      health anxiety. Participants will first undergo a baseline assessment. After that health
      anxiety is induced using the Autobiographical Emotional Memory Task and participants complete
      another assessment. Then participants are randomly assigned to either an online medical
      searching condition (experimental group, EG) or a non-searching condition (control group, CG)
      to manipulate attentional focus. The EG is requested to search online for health information
      (external focus of attention), the CG is requested to do nothing and not to distract
      themselves (internal focus of attention). Then another assessment is completed and the
      treatment groups are compared regarding the effects on affect, symptom severity and health
      anxiety. Besides examining these effects a further aim of this study is to identify the
      underlying mechanism. Two possibilities are supposed: a) An increase of the variables of
      interest due to health-related information or b) a decrease due to externalization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
measure: Change of health anxiety before and after 8 minutes of health-related internet searching or waiting
time frame: right before and after 8 minutes of health-related internet searching or waiting
description: self-created item
measure: Change of positive and negative affect before and after 8 minutes of health-related internet searching or waiting
time frame: right before and after 8 minutes of health-related internet searching or waiting
description: Positive Affect Negative Affect Schedule - State (PANAS-State)
measure: Change of symptom severity before and after 8 minutes of health-related internet searching or waiting
time frame: right before and after 8 minutes of health-related internet searching or waiting
description: Checklist for symptoms in daily life (CSD)
measure: Change of health anxiety before and after 10 minutes of anxiety induction
time frame: right before and after 10 minutes of anxiety induction
description: self-created item
measure: Change of positive and negative affect before and after 10 minutes of anxiety induction
time frame: right before and after 10 minutes of anxiety induction
description: Positive Affect Negative Affect Schedule - State (PANAS-State)
measure: Change of symptom severity before and after 10 minutes of anxiety induction
time frame: right before and after 10 minutes of anxiety induction
description: Checklist for symptoms in daily life (CSD)
arm group label: Searching condition
arm group type: Experimental
description: To simulate participants' natural behavior they are requested to search online for personally relevant health or illness information in their usual manner. By doing so their attentional focus lies on the searching process and the information they obtain.
arm group label: Waiting condition (i.e. non- searching, no distraction)
arm group type: No Intervention
description: Participants are requested to do nothing and not to distract themselves by reading or using their smartphone for instance. By doing so, it is expected that their attentional focus lies on their induced worries and symptoms.
intervention type: Behavioral
intervention name: Health- and illness-related internet use
arm group label: Searching condition
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Witthoeft, Professor
role: Study Chair
affiliation: Department of Clinical Psychology, Psychotherapy and Experimental Psychopathology, Johannes Gutenberg University Mainz
last name: Sandra K Hamann, Dipl.-Psych.
phone: (+49) 6131 - 3939 214
email: sahamann@uni-mainz.de
url: https://www.blogs.uni-mainz.de/fb02-kp-pt-epp/forschung/cyberchondrie/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Sandra K. Hamann
investigator title: Principal Investigator
mesh term: Hypochondriasis