Internet Treatment for Health Anxiety

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hypochondriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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internet-based CBT

Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided

Group Type EXPERIMENTAL

CBT, exposure and response prevention

Intervention Type BEHAVIORAL

This intervention entails different exercises aimed exposure to health anxiety stimuli.

internet-based BSM

behavioral stress management delivered via the internet: 12 weeks, therapist-guided

Group Type ACTIVE_COMPARATOR

BSM, stress management and applied relaxation

Intervention Type BEHAVIORAL

BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.

Interventions

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CBT, exposure and response prevention

This intervention entails different exercises aimed exposure to health anxiety stimuli.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No