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

Somatic Symptom Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966705
• Other study ID #: InterBib
• Status: Completed
• Phase: N/A
• First received: October 17, 2013
• Last updated: November 4, 2015
• Start date: October 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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)

• 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Illness Anxiety Disorder
• Severe Health Anxiety
• Somatic Symptom Disorder

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

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. — View Citation

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

Jones FA. The role of bibliotherapy in health anxiety: an experimental study. Br J Community Nurs. 2002 Oct;7(10):498-504. — View Citation

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. — 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, 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	No
Other	The treatment credibility scale	For assessing treatment credibility and expectancy of improvement	Weeks 2 and 8	No
Primary	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	No
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	No
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	No
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	No
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	No
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	No
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	No
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	No
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	No
Secondary	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	No
Secondary	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	No
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	No
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	No
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	No
Secondary	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	No
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	No

External Links

•   On Somatic Symptom Disorder