Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

Study Overview
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Brief Summary
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Background Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety. Aim of the study The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety. Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.

Official Title
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Self-help Based Cognitive Behavior Therapy for Health Anxiety Delivered Via the Internet or in Book Form - the Effect of Administration Strategy and Therapist Contact: a Randomized Controlled Trial

Conditions
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Severe Health Anxiety, Somatic Symptom Disorder, Illness Anxiety Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)
* Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
* Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A primary diagnosis of severe health anxiety (somatic symptom disorder or illness anxiety disorder) according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) 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 Severe major depressive disorder Higher than 5 on the suicidality scale of the Mini International diagnostic Interview Non-stable antidepressant medication (changed during the last 2 months) or not agreeing to keep dosage constant throughout the study Ongoing concurrent psychological treatment for severe health anxiety Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy during the recent year 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: Therapist-guided Internet-based Cognitive Behavior Therapy<br>Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help | Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)<br>* This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.<br>|
| Experimental: Unguided Internet-based Cognitive Behavior Therapy<br>Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only | Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)<br>* This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are not guided by a therapist. Treatment is delivered via the Internet.<br>|
| Experimental: Cognitive Behavior Therapy-based bibliotherapy<br>Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only | Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)<br>* This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are not guided by a therapist. Treatment is delivered in book form.<br>|
| No Intervention: Waiting-list condition<br>No intervention: 12 weeks | |

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 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 | 
| Sheehan Disability Scale (SDS) | Change in SDS at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 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 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 | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | Only for assessing the sample on this symptom domain | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| Alcohol Use Disorders Identification Test (AUDIT) | Change in AUDIT 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 | 
| Self-rated health 5 (SRH-5) | Change in SRH-5 at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| The Swedish Scales of Personalities | Change in The Swedish Scales of Personalities at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| Quality of Life Inventory (QOLI) | Change in QOLI at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe health anxiety, somatic symptom disorder, illness anxiety disorder, cognitive behavior therapy, bibliotherapy, internet, exposure