Internet Treatment for Health Anxiety

Study Overview
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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.

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.

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

Conditions
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Hypochondriasis

Intervention / Treatment
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* Behavioral: CBT, exposure and response prevention
* Behavioral: BSM, stress management and applied relaxation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Anxiety Inventory (HAI) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | Only for assessing the sample on this symptom domain at pre-treatment. | baseline | 
| Yale-brown obsessive compulsive scale (YBOCS) | 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) | Change in AUDIT at post-treatment and follow-ups compared to baseline. | baseline, 12 weeks, 6 month follow-up, 12 month follow-up |