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

Karolinska Institute

Status: Completed

Conditions: Somatic Symptom Disorder; Illness Anxiety Disorder; Severe Health Anxiety

Treatments: Behavioral: CBT, exposure and response prevention (Face-to-face); Behavioral: CBT, exposure and response prevention (Internet-based)

Study type: Interventional

Funder types: Other

Identifiers

NCT02314065

HA-NonInf

Details and patient eligibility

About

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.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 2 patient groups

Conventional CBT

Experimental group

Description:

Cognitive Behavioural Therapy delivered in a conventional manner

Treatment:

Behavioral: CBT, exposure and response prevention (Face-to-face)

Internet-delivered CBT

Experimental group

Description:

Cognitive Behavioural Therapy delivered via the Internet

Treatment:

Behavioral: CBT, exposure and response prevention (Internet-based)