Internet Treatment for Health Anxiety (HA-X)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01673035
First received: August 22, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Hypochondriasis
Behavioral: CBT, exposure and response prevention
Behavioral: BSM, stress management and applied relaxation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Health Anxiety Inventory (HAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in HAI at post-treatment and follow-ups compared to baseline


Secondary Outcome Measures:
  • Illness attitude scale (IAS) [ Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in IAS at post-treatment and follow-ups compared to baseline

  • Whiteley Index (WI) [ Time Frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in WI at post-treatment and follow-ups compared to baseline

  • Montgomery Åsberg depression rating scale-self report (MADRS-S) [ Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in MADRS-S at post-treatment and follow-ups compared to baseline.

  • Beck Anxiety Inventory (BAI) [ Time Frame: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in BAI at post-treatment and follow-ups compared to baseline.

  • Anxiety Sensitivity Index (ASI) [ Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in ASI at post-treatment and follow-ups compared to baseline

  • Insomnia severity index (ISI) [ Time Frame: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in ISI at post-treatment and follow-ups compared to baseline

  • Sheehan disability scale (SDS) [ Time Frame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in SDS at post-treatment and follow-ups compared to baseline

  • 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 ] [ Designated as safety issue: No ]
    Change in TIC-P at post-treatment and follow-ups compared to baseline

  • Euroqol-5D (EQ-5D) [ Time Frame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up ] [ Designated as safety issue: No ]
    Change in EQ-5D)I at post-treatment and follow-ups compared to baseline

  • Obsessive compulsive inventory revised (OCI-R) [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Only for assessing the sample on this symptom domain at pre-treatment.

  • Yale-brown obsessive compulsive scale (YBOCS) [ Time Frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52 ] [ Designated as safety issue: No ]
    only for assessing the sample on this domain at pre-treatment

  • AUDIT (alcohol use) [ Time Frame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in AUDIT at post-treatment and follow-ups compared to baseline.


Other Outcome Measures:
  • psychological mediators [ Time Frame: week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12 ] [ Designated as safety issue: No ]
    Assessment of whether these mediators will precede change in outcome during the treatment


Estimated Enrollment: 220
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673035

Locations
Sweden
Karolinska Institutet
Stockholm,, Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Erik Hedman, phd Karolinska Institutet
  More Information

No publications provided

Responsible Party: Erik Hedman, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01673035     History of Changes
Other Study ID Numbers: HA-X
Study First Received: August 22, 2012
Last Updated: February 7, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Hypochondriasis
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014