Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy
NCT ID: NCT02314065
Last Updated: 2020-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2014-12-10
2018-07-23
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional CBT
Cognitive Behavioural Therapy delivered in a conventional manner
CBT, exposure and response prevention (Face-to-face)
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.
Internet-delivered CBT
Cognitive Behavioural Therapy delivered via the Internet
CBT, exposure and response prevention (Internet-based)
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.
Interventions
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CBT, exposure and response prevention (Face-to-face)
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.
CBT, exposure and response prevention (Internet-based)
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.
Eligibility Criteria
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Inclusion Criteria
* Registered citizen of Stockholm county
* At least 18 years old
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Erik Hedman
PhD
Principal Investigators
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Erik Hedman, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Gustavsberg primary care clinic
Gustavsberg, Stockholm County, Sweden
Countries
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References
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Hedman E, Andersson E, Lindefors N, Andersson G, Ruck C, Ljotsson 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.
Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.
Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JA, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther. 2014 Jul;58:65-74. doi: 10.1016/j.brat.2014.05.002. Epub 2014 May 24.
Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
Axelsson E, Osterman S, Hedman-Lagerlof E. Joint factor analysis and approximate equipercentile linking of common trait health anxiety measures: a cross-sectional study of the 14-, 18- and 64-item health anxiety inventory, the illness attitude scale, and the 14-item Whiteley Index. BMC Psychiatry. 2023 Sep 6;23(1):658. doi: 10.1186/s12888-023-05151-7.
Axelsson E, Andersson E, Ljotsson B, Bjorkander D, Hedman-Lagerlof M, Hedman-Lagerlof E. Effect of Internet vs Face-to-Face Cognitive Behavior Therapy for Health Anxiety: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2020 Sep 1;77(9):915-924. doi: 10.1001/jamapsychiatry.2020.0940.
Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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HA-NonInf
Identifier Type: -
Identifier Source: org_study_id