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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Completed
• CT.gov ID: NCT01966705
• Collaborator: (none)
• Enrollment: 132
• Location: 1
• Arms: 4
• Duration (Months): 25
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Severe Health Anxiety; Somatic Symptom Disorder; Illness Anxiety Disorder	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)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 132 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Health Anxiety Inventory (HAI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in HAI at post-treatment and follow-ups compared to baseline

Secondary Outcome Measures

1. Illness Attitude Scale (IAS) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in IAS at post-treatment and follow-ups compared to baseline

2. Whiteley Index (WI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in WI at post-treatment and follow-ups compared to baseline

3. Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in MADRS-S at post-treatment and follow-ups compared to baseline

4. Beck Anxiety Inventory (BAI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in BAI at post-treatment and follow-ups compared to baseline

5. Anxiety Sensitivity Index (ASI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in ASI at post-treatment and follow-ups compared to baseline

6. Sheehan Disability Scale (SDS) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in SDS at post-treatment and follow-ups compared to baseline

7. Trimbos and institute of medical technology assessment cost questionnaire (TIC-P) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in TIC-P at post-treatment and follow-ups compared to baseline

8. Euroqol-5D (EQ-5D) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Change in EQ-5D at post-treatment and follow-ups compared to baseline

9. Obsessive Compulsive Inventory Revised (OCI-R) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

   Only for assessing the sample on this symptom domain

10. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Only for assessing the sample on this symptom domain

11. Alcohol Use Disorders Identification Test (AUDIT) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Change in AUDIT at post-treatment and follow-ups compared to baseline

12. Insomnia Severity Index (ISI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Change in ISI at post-treatment and follow-ups compared to baseline

13. Self-rated health 5 (SRH-5) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Change in SRH-5 at post-treatment and follow-ups compared to baseline

14. The Swedish Scales of Personalities [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Change in The Swedish Scales of Personalities at post-treatment and follow-ups compared to baseline

15. Quality of Life Inventory (QOLI) [baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up]

    Change in QOLI at post-treatment and follow-ups compared to baseline

Other Outcome Measures

1. Psychological mediators [week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12]

   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

2. The treatment credibility scale [Weeks 2 and 8]

   For assessing treatment credibility and expectancy of improvement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet	Stockholm		Sweden	17177

Sponsors and Collaborators

• Karolinska Institutet

Investigators

• Principal Investigator: Erik Hedman, phd, Karolinska Institutet

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• On Somatic Symptom Disorder

Publications

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

• Responsible Party: Erik Hedman, phd, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT01966705
• Other Study ID Numbers: InterBib
• First Posted: Oct 22, 2013
• Last Update Posted: Nov 5, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Erik Hedman, phd, Karolinska Institutet: severe health anxiety; somatic symptom disorder; illness anxiety disorder; cognitive behavior therapy; bibliotherapy; internet; exposure
• Additional relevant MeSH terms: Disease; Medically Unexplained Symptoms; Anxiety Disorders

Study Results

No Results Posted as of Nov 5, 2015