Clinical trial NCT02314065: Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy
Official title: Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Health Anxiety Inventory (HAI)
timeFrame: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Illness Attitude Scale (IAS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Whiteley Index (WI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Anxiety Sensitivity Index (ASI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Sheehan Disability Scale (SDS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Euroqol-5D (EQ-5D)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Self-rated health 5 (SRH-5)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Quality of Life Inventory (QOLI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (12 weeks)
measure: Sickness Questionnaire (SQ)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Perceived Vulnerability for Disease (PVD)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Disgust Scale-Rev (DS-R)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Other outcomes:
measure: Psychological mediators
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Credibility/Expectancy scale
timeFrame: Weeks 2 and 8
measure: Working Alliance Inventory (WAI)
timeFrame: Weeks 2 and 8
Locations:
city: Gustavsberg
country: Sweden
facility: Gustavsberg primary care clinic
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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.
citation: Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
citation: 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.
citation: 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.