Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy (HA-NonInf)

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

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.

Severe health anxiety, Somatic symptom disorder, Illness anxiety disorder, Cognitive behavioral therapy, Internet, Exposure

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.

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.

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.

Assessment of whether these mediators will precede change in outcome during the treatment. Mediators will be assessed using sub scales of the Health Anxiety Inventory, the Insomnia Severity Index, Self-Rated Health 5 and Acceptance/Flexibility. Common health anxiety behaviors will also be assessed.

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

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