<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/NCT03019705</url>
  </required_header>
  <id_info>
    <org_study_id>C2-aA</org_study_id>
    <nct_id>NCT03019705</nct_id>
  </id_info>
  <brief_title>An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety Using Ambulatory Assessment</brief_title>
  <official_title>An Examination of the Effects of Health-related Internet Use in Individuals With Pathological Health Anxiety Using Ambulatory Assessment</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 explorative study is to examine the effects of health-related&#xD;
      internet use in individuals with pathological health anxiety using ambulatory assessment. In&#xD;
      a naturalistic setting participants answer over a seven-day period questionnaires about their&#xD;
      health-related internet use and its effects on affect, health anxiety and symptom severity in&#xD;
      their usual daily lives.&#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 questions, because compared to other methods (e.g. going to the&#xD;
      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 observational study aims to investigate the effects of health-related internet use in&#xD;
      individuals with pathological health anxiety in a naturalistic setting using ambulatory&#xD;
      assessment. The variables of interest are monitored using time- and event-based sampling&#xD;
      methods. Therefore, over a seven-day period participants answer seven times a day&#xD;
      questionnaires on a mobile phone in their usual daily lives and additionally track the&#xD;
      variables of interest in the moment the target behavior (health-related internet use) occurs.&#xD;
      To our knowledge, this is the first study to investigate these relations using ambulatory&#xD;
      assessment and therefore additionally aims to investigate the feasibility of this study&#xD;
      design in this specific field of research.&#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>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of health anxiety before and after health-related internet use</measure>
    <time_frame>Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days</time_frame>
    <description>Self-created item. The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of positive and negative affect before and after health-related internet use</measure>
    <time_frame>Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days</time_frame>
    <description>Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German.&#xD;
The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of symptom severity before and after health-related internet</measure>
    <time_frame>Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days</time_frame>
    <description>Self-created item. The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of health anxiety before and after health-related internet use</measure>
    <time_frame>Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period</time_frame>
    <description>Self-created item. Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of positive and negative affect before and after health-related internet use</measure>
    <time_frame>Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period</time_frame>
    <description>Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German.&#xD;
Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this questionnaire.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of symptom severity before and after health-related internet</measure>
    <time_frame>Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period</time_frame>
    <description>Self-created item. Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frequency of occurence of health-related internet use</measure>
    <time_frame>during seven days</time_frame>
    <description>start of health-related internet use is recorded by the push of a special button on the mobile phone</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Health Anxiety</condition>
  <arm_group>
    <arm_group_label>Participants</arm_group_label>
    <description>Individuals with pathological health anxiety</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <arm_group_label>Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        individuals with pathological health anxiety&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <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 mobile phone 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 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 10, 2017</last_update_submitted>
  <last_update_submitted_qc>January 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 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>
  <keyword>ambulatory assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT03019705
org study id: C2-aA
nct id: NCT03019705
lead sponsor: 
collaborator: 
The purpose of the current explorative study is to examine the effects of health-related
      internet use in individuals with pathological health anxiety using ambulatory assessment. In
      a naturalistic setting participants answer over a seven-day period questionnaires about their
      health-related internet use and its effects on affect, health anxiety and symptom severity in
      their usual daily lives.
The internet is a popular method for obtaining information. Increasingly, it is also used to
      answer medical and health 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 observational study aims to investigate the effects of health-related internet use in
      individuals with pathological health anxiety in a naturalistic setting using ambulatory
      assessment. The variables of interest are monitored using time- and event-based sampling
      methods. Therefore, over a seven-day period participants answer seven times a day
      questionnaires on a mobile phone in their usual daily lives and additionally track the
      variables of interest in the moment the target behavior (health-related internet use) occurs.
      To our knowledge, this is the first study to investigate these relations using ambulatory
      assessment and therefore additionally aims to investigate the feasibility of this study
      design in this specific field of research.
observational model: Case-Only
time perspective: Prospective
measure: Change of health anxiety before and after health-related internet use
time frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
description: Self-created item. The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.
measure: Change of positive and negative affect before and after health-related internet use
time frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
description: Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German.
The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.
measure: Change of symptom severity before and after health-related internet
time frame: Time-based sampling: every day at 9am, 11am, 1pm, 3pm, 5pm, 7pm and 9pm during seven days
description: Self-created item. The occurence of health-related internet use is indicated by answering a question (yes/no) for a specific time period (e.g. between 9am and 11am), then the difference score for levels of health anxiety between these two time points is calculated.
measure: Change of health anxiety before and after health-related internet use
time frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
description: Self-created item. Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.
measure: Change of positive and negative affect before and after health-related internet use
time frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
description: Short-form of the Positive Affect Negative Affect Schedule -State (PANAS-State) by Thompson (2007), translated into German.
Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this questionnaire.
measure: Change of symptom severity before and after health-related internet
time frame: Event-based sampling: before and after every health-related internet use that is conducted during a seven-day-period
description: Self-created item. Start and end of health-related internet use is indicated by the push of a special button on the mobile phone and triggers the presentation of this item.
measure: frequency of occurence of health-related internet use
time frame: during seven days
description: start of health-related internet use is recorded by the push of a special button on the mobile phone
arm group label: Participants
description: Individuals with pathological health anxiety
intervention type: Other
intervention name: Observation
arm group label: Participants
study pop: 
sampling method: Non-Probability Sample
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: Anxiety Disorders