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

Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy

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.

Study Overview

• Status: Completed
• Conditions: Illness Anxiety Disorder; Somatic Symptom Disorder; Severe Health Anxiety
• Intervention / Treatment: Behavioral: CBT, exposure and response prevention (Face-to-face); Behavioral: CBT, exposure and response prevention (Internet-based)

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Gustavsberg, Stockholm, Sweden, 13440
      • Gustavsberg primary care clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional CBT; Cognitive Behavioural Therapy delivered in a conventional manner	Behavioral: 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.
EXPERIMENTAL: Internet-delivered CBT; Cognitive Behavioural Therapy delivered via the Internet	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Illness Attitude Scale (IAS)	Change in IAS at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Whiteley Index (WI)	Change in WI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)	Change in MADRS-S at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Beck Anxiety Inventory (BAI)	Change in BAI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Anxiety Sensitivity Index (ASI)	Change in ASI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Sheehan Disability Scale (SDS)	Change in SDS at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)	Change in TIC-P at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Euroqol-5D (EQ-5D)	Change in EQ-5D at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Alcohol Use Disorders Identification Test (AUDIT)	Change in AUDIT at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity Index (ISI)	Change in ISI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Self-rated health 5 (SRH-5)	Change in SRH-5 at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Quality of Life Inventory (QOLI)	Change in QOLI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Client Satisfaction Questionnaire (CSQ-8)	For assessing satisfaction with treatment	Post-treatment (12 weeks)
Sickness Questionnaire (SQ)	Change in SQ at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Perceived Vulnerability for Disease (PVD)	Change in PVD at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Disgust Scale-Rev (DS-R)	Change in DS-R at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version	Change in WHODAS at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological mediators	Assessment of whether these mediators will precede change in outcome during the treatment. Mediators will be assessed using sub scales of the Health Anxiety Inventory, the Insomnia Severity Index, Self-Rated Health 5 and Acceptance/Flexibility. Common health anxiety behaviors will also be assessed.	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Credibility/Expectancy scale	For assessing treatment credibility and expectancy of improvement	Weeks 2 and 8
Working Alliance Inventory (WAI)	For assessing therapeutic alliance	Weeks 2 and 8

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik Hedman, Ph.D., Karolinska Institutet

Publications and helpful links

General Publications

• 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, 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.

Helpful Links

• On Somatic Symptom Disorder

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 10, 2014
• Primary Completion (ACTUAL): July 23, 2018
• Study Completion (ACTUAL): July 23, 2018

Study Registration Dates

• First Submitted: December 8, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (ESTIMATE): December 10, 2014

Study Record Updates

• Last Update Posted (ACTUAL): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 28, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Exposure; Internet; Somatic symptom disorder; Severe health anxiety; Illness anxiety disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: HA-NonInf