Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

NCT02314065 | Completed DMC

• 1 other identifier: HA-NonInf
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Health Anxiety; Somatic Symptom Disorder; Illness Anxiety Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Health Anxiety Inventory (HAI)

  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.

  baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up

Secondary Outcomes (17)

• Illness Attitude Scale (IAS)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Whiteley Index (WI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Beck Anxiety Inventory (BAI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Anxiety Sensitivity Index (ASI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

Other Outcomes (3)

• Psychological mediators

  week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• Credibility/Expectancy scale

  Weeks 2 and 8

• Working Alliance Inventory (WAI)

  Weeks 2 and 8

Study Arms (2)

Conventional CBT

EXPERIMENTAL

Cognitive Behavioural Therapy delivered in a conventional manner

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

Internet-delivered CBT

EXPERIMENTAL

Cognitive Behavioural Therapy delivered via the Internet

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

Interventions

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

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.

Conventional CBT

CBT, exposure and response prevention (Internet-based) BEHAVIORAL

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.

Internet-delivered CBT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Gustavsberg primary care clinic

Gustavsberg, Stockholm County, 13440, Sweden

Location

Related Publications (7)

• 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.

  PMID: 22608115 BACKGROUND

• 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.

  PMID: 25104835 BACKGROUND

• 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.

  PMID: 24954212 BACKGROUND

• Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.

  BACKGROUND

• 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.

  PMID: 37674135 DERIVED

• 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.

  PMID: 32401286 DERIVED

• 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.

  PMID: 29222080 DERIVED

Study Officials

• Erik Hedman, Ph.D.

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: December 10, 2014
• Primary Completion: July 23, 2018
• Study Completion: July 23, 2018
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

SE (1)