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

Karolinska Institute

Status: Completed

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

Treatments: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided); Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided); Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)

Study type: Interventional

Funder types: Other

Identifiers

NCT01966705

InterBib

Details and patient eligibility

About

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.

Enrollment: 132 estimated 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)
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 4 patient groups

Therapist-guided Internet-based Cognitive Behavior Therapy

Experimental group

Description:

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help

Treatment:

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)

Unguided Internet-based Cognitive Behavior Therapy

Experimental group

Description:

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only

Treatment:

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)

Cognitive Behavior Therapy-based bibliotherapy

Experimental group

Description:

Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only

Treatment:

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)

Waiting-list condition

No Intervention group

Description:

No intervention: 12 weeks