<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/NCT01673035</url>
  </required_header>
  <id_info>
    <org_study_id>HA-X</org_study_id>
    <nct_id>NCT01673035</nct_id>
  </id_info>
  <brief_title>Internet Treatment for Health Anxiety</brief_title>
  <acronym>HA-X</acronym>
  <official_title>Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background&#xD;
&#xD;
      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with&#xD;
      functional disability. Cognitive behavior therapy (CBT) and behavioral stress management&#xD;
      (BSM) have been showed to be effective in the treatment of severe health anxiety. The&#xD;
      mechanisms of the treatments are however poorly understood. In addition, effective&#xD;
      psychological treatments are accessible to only a few. One prior RCT has shown that&#xD;
      internet-based CBT could be effective in comparison to waiting list controls. More studies on&#xD;
      internet-based CBT is essential to establish evidence. In addition, few studies with&#xD;
      sufficient power have investigated the effect of CBT in comparison to other active&#xD;
      treatments.&#xD;
&#xD;
      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to&#xD;
      behavioral stress management (n=110) for adult participants with severe health anxiety. BSM&#xD;
      is considered a comparison treatment for two reasons: it has been shown to be effective and&#xD;
      it lacks exposure and response prevention, which is suggested to be an important mechanism in&#xD;
      CBT.&#xD;
&#xD;
      Participants in both treatments are expected to be significantly improved on measures of&#xD;
      health anxiety. Participants receiving CBT are expected to be significantly more improved&#xD;
      compared to participants receiving BSM.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background&#xD;
&#xD;
      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with&#xD;
      functional disability. Cognitive behavior therapy (CBT) and behavioral stress management&#xD;
      (BSM) have been showed to be effective in the treatment of severe health anxiety. The&#xD;
      mechanisms of the treatments are however poorly understood. In addition, effective&#xD;
      psychological treatments are accessible to only a few. One prior RCT has shown that&#xD;
      internet-based CBT could be effective in comparison to waiting list controls. More studies on&#xD;
      internet-based CBT is essential to establish evidence. In addition, few studies with&#xD;
      sufficient power have investigated the effect of CBT in comparison to other active&#xD;
      treatments.&#xD;
&#xD;
      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to&#xD;
      behavioral stress management (n=110) for adult participants with severe health anxiety. BSM&#xD;
      is considered a comparison treatment for two reasons: it has been shown to be effective and&#xD;
      it lacks exposure and response prevention, which is suggested to be an important mechanism in&#xD;
      CBT.&#xD;
&#xD;
      The investigators expect participants in both treatments to be significantly improved on&#xD;
      measures of health anxiety. Participants receiving CBT are expected to be significantly more&#xD;
      improved compared to participants receiving BSM.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      Randomized controlled trial. Participants are randomized in a 1:1 ratio.&#xD;
&#xD;
      Assessments:&#xD;
&#xD;
      The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are&#xD;
      conducted at baseline, post-treatment, 3- and 12 month follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Health Anxiety Inventory (HAI)</measure>
    <time_frame>baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up</time_frame>
    <description>Change in HAI at post-treatment and follow-ups compared to baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Illness attitude scale (IAS)</measure>
    <time_frame>baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in IAS at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Whiteley Index (WI)</measure>
    <time_frame>baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up</time_frame>
    <description>Change in WI at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Montgomery Åsberg depression rating scale-self report (MADRS-S)</measure>
    <time_frame>baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in MADRS-S at post-treatment and follow-ups compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory (BAI)</measure>
    <time_frame>baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up</time_frame>
    <description>Change in BAI at post-treatment and follow-ups compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety Sensitivity Index (ASI)</measure>
    <time_frame>baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in ASI at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insomnia severity index (ISI)</measure>
    <time_frame>baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in ISI at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sheehan disability scale (SDS)</measure>
    <time_frame>baseline, post-treatment (12) 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in SDS at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)</measure>
    <time_frame>baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in TIC-P at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Euroqol-5D (EQ-5D)</measure>
    <time_frame>baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up</time_frame>
    <description>Change in EQ-5D)I at post-treatment and follow-ups compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive compulsive inventory revised (OCI-R)</measure>
    <time_frame>baseline</time_frame>
    <description>Only for assessing the sample on this symptom domain at pre-treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yale-brown obsessive compulsive scale (YBOCS)</measure>
    <time_frame>Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52</time_frame>
    <description>only for assessing the sample on this domain at pre-treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUDIT (alcohol use)</measure>
    <time_frame>baseline, 12 weeks, 6 month follow-up, 12 month follow-up</time_frame>
    <description>Change in AUDIT at post-treatment and follow-ups compared to baseline.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>psychological mediators</measure>
    <time_frame>week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12</time_frame>
    <description>Assessment of whether these mediators will precede change in outcome during the treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">178</enrollment>
  <condition>Hypochondriasis</condition>
  <arm_group>
    <arm_group_label>internet-based CBT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided</description>
  </arm_group>
  <arm_group>
    <arm_group_label>internet-based BSM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>behavioral stress management delivered via the internet: 12 weeks, therapist-guided</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CBT, exposure and response prevention</intervention_name>
    <description>This intervention entails different exercises aimed exposure to health anxiety stimuli.</description>
    <arm_group_label>internet-based CBT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BSM, stress management and applied relaxation</intervention_name>
    <description>BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.</description>
    <arm_group_label>internet-based BSM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Able to read and write in Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other primary axis-I disorder&#xD;
&#xD;
          -  Ongoing substance abuse or addiction&#xD;
&#xD;
          -  current or previous episode of psychosis or bipolar disorder&#xD;
&#xD;
          -  higher score than 30 on the Montgomery åsberg depression rating scale-self report&#xD;
&#xD;
          -  higher than 3 on the suicide item of the MADRS-S&#xD;
&#xD;
          -  non-stable antidepressant medication during last 2 months if on this kind of&#xD;
             medication&#xD;
&#xD;
          -  ongoing concurrent psychological treatment for severe health anxiety&#xD;
&#xD;
          -  having received previous high quality CBT during the recent 3 years&#xD;
&#xD;
          -  ongoing serious somatic disorder&#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>Erik Hedman, phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Stockholm,</city>
        <state>Stockholm</state>
        <zip>17177</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>March 2, 2016</last_update_submitted>
  <last_update_submitted_qc>March 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Erik Hedman</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT01673035
org study id: HA-X
nct id: NCT01673035
lead sponsor: 
has dmc: No
Background

      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with
      functional disability. Cognitive behavior therapy (CBT) and behavioral stress management
      (BSM) have been showed to be effective in the treatment of severe health anxiety. The
      mechanisms of the treatments are however poorly understood. In addition, effective
      psychological treatments are accessible to only a few. One prior RCT has shown that
      internet-based CBT could be effective in comparison to waiting list controls. More studies on
      internet-based CBT is essential to establish evidence. In addition, few studies with
      sufficient power have investigated the effect of CBT in comparison to other active
      treatments.

      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to
      behavioral stress management (n=110) for adult participants with severe health anxiety. BSM
      is considered a comparison treatment for two reasons: it has been shown to be effective and
      it lacks exposure and response prevention, which is suggested to be an important mechanism in
      CBT.

      Participants in both treatments are expected to be significantly improved on measures of
      health anxiety. Participants receiving CBT are expected to be significantly more improved
      compared to participants receiving BSM.
Background

      Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with
      functional disability. Cognitive behavior therapy (CBT) and behavioral stress management
      (BSM) have been showed to be effective in the treatment of severe health anxiety. The
      mechanisms of the treatments are however poorly understood. In addition, effective
      psychological treatments are accessible to only a few. One prior RCT has shown that
      internet-based CBT could be effective in comparison to waiting list controls. More studies on
      internet-based CBT is essential to establish evidence. In addition, few studies with
      sufficient power have investigated the effect of CBT in comparison to other active
      treatments.

      Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to
      behavioral stress management (n=110) for adult participants with severe health anxiety. BSM
      is considered a comparison treatment for two reasons: it has been shown to be effective and
      it lacks exposure and response prevention, which is suggested to be an important mechanism in
      CBT.

      The investigators expect participants in both treatments to be significantly improved on
      measures of health anxiety. Participants receiving CBT are expected to be significantly more
      improved compared to participants receiving BSM.

      Design:

      Randomized controlled trial. Participants are randomized in a 1:1 ratio.

      Assessments:

      The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are
      conducted at baseline, post-treatment, 3- and 12 month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Health Anxiety Inventory (HAI)
time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
description: Change in HAI at post-treatment and follow-ups compared to baseline
measure: Illness attitude scale (IAS)
time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
description: Change in IAS at post-treatment and follow-ups compared to baseline
measure: Whiteley Index (WI)
time frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
description: Change in WI at post-treatment and follow-ups compared to baseline
measure: Montgomery Åsberg depression rating scale-self report (MADRS-S)
time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
description: Change in MADRS-S at post-treatment and follow-ups compared to baseline.
measure: Beck Anxiety Inventory (BAI)
time frame: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
description: Change in BAI at post-treatment and follow-ups compared to baseline.
measure: Anxiety Sensitivity Index (ASI)
time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
description: Change in ASI at post-treatment and follow-ups compared to baseline
measure: Insomnia severity index (ISI)
time frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
description: Change in ISI at post-treatment and follow-ups compared to baseline
measure: Sheehan disability scale (SDS)
time frame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
description: Change in SDS at post-treatment and follow-ups compared to baseline
measure: Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
time frame: baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
description: Change in TIC-P at post-treatment and follow-ups compared to baseline
measure: Euroqol-5D (EQ-5D)
time frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
description: Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
measure: Obsessive compulsive inventory revised (OCI-R)
time frame: baseline
description: Only for assessing the sample on this symptom domain at pre-treatment.
measure: Yale-brown obsessive compulsive scale (YBOCS)
time frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
description: only for assessing the sample on this domain at pre-treatment
measure: AUDIT (alcohol use)
time frame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up
description: Change in AUDIT at post-treatment and follow-ups compared to baseline.
measure: psychological mediators
time frame: week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12
description: Assessment of whether these mediators will precede change in outcome during the treatment
arm group label: internet-based CBT
arm group type: Experimental
description: Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided
arm group label: internet-based BSM
arm group type: Active Comparator
description: behavioral stress management delivered via the internet: 12 weeks, therapist-guided
intervention type: Behavioral
intervention name: CBT, exposure and response prevention
description: This intervention entails different exercises aimed exposure to health anxiety stimuli.
arm group label: internet-based CBT
intervention type: Behavioral
intervention name: BSM, stress management and applied relaxation
description: BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.
arm group label: internet-based BSM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erik Hedman, phd
role: Principal Investigator
affiliation: Karolinska Institutet
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Erik Hedman
investigator title: Principal investigator
mesh term: Hypochondriasis