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Internet Treatment for Health Anxiety (HA-X)

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Karolinska Institute

Status

Completed

Conditions

Hypochondriasis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

178 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

178 participants in 2 patient groups

internet-based CBT
Experimental group
Description:
Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided
Treatment:
Behavioral: CBT, exposure and response prevention
internet-based BSM
Active Comparator group
Description:
behavioral stress management delivered via the internet: 12 weeks, therapist-guided
Treatment:
Behavioral: BSM, stress management and applied relaxation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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