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

Severe Health Anxiety research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Severe Health Anxiety

Somatic Symptom Disorder

Illness Anxiety Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Therapist-guided Internet-based Cognitive Behavior TherapyCognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help

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

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

Waiting-list conditionNo intervention: 12 weeks

Study Status

Completed

Start Date: October 2013

Completed Date: November 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Health Anxiety Inventory (HAI)

Secondary Outcome: Illness Attitude Scale (IAS)

Study sponsors, principal investigator, and references

Principal Investigator: Erik Hedman, phd

Lead Sponsor: Karolinska Institutet

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01966705

Hedman E, Andersson E, Lindefors N, Andersson G, Rück C, Ljótsson B. Cost-effectiveness and long-term effectiveness of internet-based cognitive behaviour therapy for severe health anxiety. Psychol Med. 2013 Feb;43(2):363-74. doi: 10.1017/S0033291712001079. Epub 2012 May 21.

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