Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help

Self-help Based Cognitive Behavior Therapy for Health Anxiety Delivered Via the Internet or in Book Form - the Effect of Administration Strategy and Therapist Contact: a Randomized Controlled Trial

Background

Severe health anxiety, Somatic symptom disorder or Illness anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5), is associated with considerable personal distress, functional disability and societal costs. Several studies have demonstrated the efficacy of Cognitive Behavior Therapy (CBT) for severe health anxiety, both on anxiety itself and on secondary symptom measures (for example of depression). One published randomized controlled trial (RCT) has examined the feasibility of delivering CBT for severe health anxiety via the Internet as a form of guided self help. Participants had contact with a therapist via an e-mail-like system throughout the treatment. This approach yielded results superior to a waiting-list condition, thus potentially greatly increasing the availability of psychological treatment. However, more studies on the effects of Internet-delivered CBT are warranted (NCT01673035 being one). Additionally, little is known about the active ingredients and mechanisms of change involved in Internet-delivered CBT. For example, the significance of therapist support in relation to treatment outcomes remains to be determined. CBT-based self-help literature, so called bibliotherapy, has shown great promise in the treatment of several anxiety disorders, including panic disorder and social anxiety disorder. Two small pilot studies have indicated that bibliotherapy with no or minimal therapist contact could be suitable for treating health anxiety.

Aim of the study

The aim of the present RCT is to compare therapist-guided Internet-delivered CBT (n=33), Internet-delivered CBT without therapist guidance (n=33), CBT-based bibliotherapy without therapist guidance (n=33) and a waiting-list control condition (n=33) for adult participants with severe health anxiety.

Participants in all treatment programs are expected to be significantly improved on measures of health anxiety, compared to participants allocated to the waiting-list condition.

Study Overview

• Status: Completed
• Conditions: Illness Anxiety Disorder; Somatic Symptom Disorder; Severe Health Anxiety
• Intervention / Treatment: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided); Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided); Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet

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)
• At least 18 years old
• Able to read and write in Swedish

Exclusion Criteria:

• Other primary axis-I disorder
• Ongoing substance abuse or addiction
• Current or previous episode of psychosis or bipolar disorder
• Severe major depressive disorder
• Higher than 5 on the suicidality scale of the Mini International diagnostic Interview
• Non-stable antidepressant medication (changed during the last 2 months) or not agreeing to keep dosage constant throughout the study
• Ongoing concurrent psychological treatment for severe health anxiety
• Having received previous high quality Cognitive Therapy or Cognitive Behavior Therapy during the recent year
• Ongoing serious somatic disorder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapist-guided Internet-based Cognitive Behavior Therapy; Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help	Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided); This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.
Experimental: Unguided Internet-based Cognitive Behavior Therapy; Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only	Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided); This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are not guided by a therapist. Treatment is delivered via the Internet.
Experimental: Cognitive Behavior Therapy-based bibliotherapy; Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only	Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided); This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are not guided by a therapist. Treatment is delivered in book form.
No Intervention: Waiting-list condition; No intervention: 12 weeks

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	baseline, post-treatment (12 weeks), 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
Obsessive Compulsive Inventory Revised (OCI-R)	Only for assessing the sample on this symptom domain	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	Only for assessing the sample on this symptom domain	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
The Swedish Scales of Personalities	Change in The Swedish Scales of Personalities 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

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, and the Insomnia Severity Index, Perceived Competence Scale, Working Alliance Inventory, Five Facet Mindfulness Questionnaire, Acceptance and Flexibility, and Somatosensory Amplification Scale	week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
The treatment credibility scale	For assessing treatment credibility and expectancy of improvement	Weeks 2 and 8

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik Hedman, PhD, 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.
• Jones FA. The role of bibliotherapy in health anxiety: an experimental study. Br J Community Nurs. 2002 Oct;7(10):498-504. doi: 10.12968/bjcn.2002.7.10.10662.
• Buwalda FM, Bouman TK. Cognitive-behavioural bibliotherapy for hypochondriasis: a pilot study. Behav Cogn Psychother. 2009 May;37(3):335-40. doi: 10.1017/S1352465809005293. Epub 2009 May 6.
• Salkovskis PM, Rimes KA, Warwick HM, Clark DM. The Health Anxiety Inventory: development and validation of scales for the measurement of health anxiety and hypochondriasis. Psychol Med. 2002 Jul;32(5):843-53. doi: 10.1017/s0033291702005822.
• Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.
• Hedman-Lagerlof E, Axelsson E, Andersson E, Ljotsson B, Andreasson A, Lekander M. The impact of exposure-based cognitive behavior therapy for severe health anxiety on self-rated health: Results from a randomized trial. J Psychosom Res. 2017 Dec;103:9-14. doi: 10.1016/j.jpsychores.2017.09.013. Epub 2017 Sep 28.
• Hedman E, Axelsson E, Andersson E, Lekander M, Ljotsson B. Exposure-based cognitive-behavioural therapy via the internet and as bibliotherapy for somatic symptom disorder and illness anxiety disorder: randomised controlled trial. Br J Psychiatry. 2016 Nov;209(5):407-413. doi: 10.1192/bjp.bp.116.181396. Epub 2016 Aug 4.

Helpful Links

• On Somatic Symptom Disorder

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 4, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: cognitive behavior therapy; internet; exposure; severe health anxiety; somatic symptom disorder; illness anxiety disorder; bibliotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders; Medically Unexplained Symptoms
• Other Study ID Numbers: InterBib