Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

Study Overview
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Brief Summary
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Background Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035). Aim of the study The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.

Official Title
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Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy

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

Intervention / Treatment
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* Behavioral: CBT, exposure and response prevention (Face-to-face)
* Behavioral: CBT, exposure and response prevention (Internet-based)


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) Registered citizen of Stockholm county At least 18 years old Exclusion Criteria: Other primary axis-I disorder Substance abuse or addiction during the last 6 months Current or previous episode of psychosis or bipolar disorder Severe major depressive disorder Suicide risk Personality disorder making the treatment procedure very difficult Non-stable psychiatric pharmacotherapy (dosage changed during the last 2 months) and the drug is likely to affect outcome measures Ongoing concurrent psychological treatment for severe health anxiety Having received previous high quality Cognitive Therapy or Cognitive Behavioural Therapy during the recent year Ongoing serious somatic disorder, precluding CBT

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional CBT<br>Cognitive Behavioural Therapy delivered in a conventional manner | Behavioral: CBT, exposure and response prevention (Face-to-face)<br>* This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week.<br>|
| Experimental: Internet-delivered CBT<br>Cognitive Behavioural Therapy delivered via the Internet | Behavioral: CBT, exposure and response prevention (Internet-based)<br>* This intervention entails different exercises aimed at exposure to health anxiety stimuli. Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system.<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. Analyses will be conducted both within an intention-to-treat (ITT) framework and on a complete case basis. A non-inferiority limit of 0.3 d (effect size) will be used. | baseline, post-treatment (12 weeks), weekly during treatment, 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 | 
| 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 | 
| 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 | 
| 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 | 
| Client Satisfaction Questionnaire (CSQ-8) | For assessing satisfaction with treatment | Post-treatment (12 weeks) | 
| Sickness Questionnaire (SQ) | Change in SQ at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| Perceived Vulnerability for Disease (PVD) | Change in PVD at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| Disgust Scale-Rev (DS-R) | Change in DS-R at post-treatment and follow-ups compared to baseline | baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up | 
| WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version | Change in WHODAS 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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Somatic symptom disorder, Illness anxiety disorder, Cognitive behavioral therapy, Internet, Exposure, Severe health anxiety