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

Somatic Symptom Disorder Clinical Trial

— HA-NonInf  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02314065
• Other study ID #: HA-NonInf
• Status: Completed
• Phase: N/A
• Start date: December 10, 2014
• Est. completion date: July 23, 2018

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 23, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Illness Anxiety Disorder
• Medically Unexplained Symptoms
• Severe Health Anxiety
• Somatic Symptom Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Gustavsberg primary care clinic	Gustavsberg	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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

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. — View Citation

Hedman E, Axelsson E, Görling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljótsson 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Credibility/Expectancy scale	For assessing treatment credibility and expectancy of improvement	Weeks 2 and 8
Other	Working Alliance Inventory (WAI)	For assessing therapeutic alliance	Weeks 2 and 8
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Client Satisfaction Questionnaire (CSQ-8)	For assessing satisfaction with treatment	Post-treatment (12 weeks)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   On Somatic Symptom Disorder