Internet Treatment for Health Anxiety (HA-X)

March 2, 2016 updated by: Erik Hedman, Karolinska Institutet

Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm
      • Stockholm,, Stockholm, Sweden, 17177
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV
  • At least 18 years old
  • Able to read and write in Swedish

Exclusion Criteria:

  • Other primary axis-I disorder
  • Ongoing substance abuse or addiction
  • current or previous episode of psychosis or bipolar disorder
  • higher score than 30 on the Montgomery åsberg depression rating scale-self report
  • higher than 3 on the suicide item of the MADRS-S
  • non-stable antidepressant medication during last 2 months if on this kind of medication
  • ongoing concurrent psychological treatment for severe health anxiety
  • having received previous high quality CBT during the recent 3 years
  • ongoing serious somatic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: internet-based CBT
Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided
Behavioral: CBT, exposure and response prevention
This intervention entails different exercises aimed exposure to health anxiety stimuli.
Active Comparator: internet-based BSM
behavioral stress management delivered via the internet: 12 weeks, therapist-guided
Behavioral: BSM, stress management and applied relaxation
BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health Anxiety Inventory (HAI)
Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Change in HAI at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illness attitude scale (IAS)
Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Change in IAS at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Whiteley Index (WI)
Time Frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
Change in WI at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
Montgomery Åsberg depression rating scale-self report (MADRS-S)
Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Change in MADRS-S at post-treatment and follow-ups compared to baseline.
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Beck Anxiety Inventory (BAI)
Time Frame: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
Change in BAI at post-treatment and follow-ups compared to baseline.
baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
Anxiety Sensitivity Index (ASI)
Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Change in ASI at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Insomnia severity index (ISI)
Time Frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
Change in ISI at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
Sheehan disability scale (SDS)
Time Frame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
Change in SDS at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
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
Change in TIC-P at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
Euroqol-5D (EQ-5D)
Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Obsessive compulsive inventory revised (OCI-R)
Time Frame: baseline
Only for assessing the sample on this symptom domain at pre-treatment.
baseline
Yale-brown obsessive compulsive scale (YBOCS)
Time Frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
only for assessing the sample on this domain at pre-treatment
Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
AUDIT (alcohol use)
Time Frame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up
Change in AUDIT at post-treatment and follow-ups compared to baseline.
baseline, 12 weeks, 6 month follow-up, 12 month follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychological mediators
Time Frame: week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12
Assessment of whether these mediators will precede change in outcome during the treatment
week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Erik Hedman, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 27, 2012

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HA-X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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