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

• ClinicalTrials.gov Identifier: NCT01966705
• Recruitment Status: Completed
• First Posted: October 22, 2013
• Last Update Posted: November 5, 2015
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Erik Hedman, Karolinska Institutet

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)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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: October 2013
• Actual Primary Completion Date: November 2015
• Actual Study Completion Date: November 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Weeks 2 and 8 ]
   For assessing treatment credibility and expectancy of improvement

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)
• 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

Sweden

Karolinska Institutet

Stockholm, Sweden, 17177

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Erik Hedman, phd; Karolinska Institutet

More Information

Additional Information:

On Somatic Symptom Disorder 

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

Keywords provided by Erik Hedman, Karolinska Institutet:

severe health anxiety; somatic symptom disorder; illness anxiety disorder; cognitive behavior therapy; bibliotherapy; internet; exposure

Additional relevant MeSH terms:

Medically Unexplained Symptoms; Anxiety Disorders; Mental Disorders