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

NCT01966705 | Completed DMC

• 1 other identifier: InterBib
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Health Anxiety; Somatic Symptom Disorder; Illness Anxiety Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Illness Attitude Scale (IAS)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Whiteley Index (WI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Beck Anxiety Inventory (BAI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

• Anxiety Sensitivity Index (ASI)

  baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up

Other Outcomes (2)

• Psychological mediators

  week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

• The treatment credibility scale

  Weeks 2 and 8

Study Arms (4)

Therapist-guided Internet-based Cognitive Behavior Therapy

EXPERIMENTAL

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)

Unguided Internet-based Cognitive Behavior Therapy

EXPERIMENTAL

Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)

Cognitive Behavior Therapy-based bibliotherapy

EXPERIMENTAL

Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only

Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)

Waiting-list condition

NO INTERVENTION

No intervention: 12 weeks

Interventions

Cognitive Behavior Therapy, exposure and response prevention (Internet, guided) BEHAVIORAL

This intervention entails different exercises aimed at exposure to health anxiety stimuli. Participants are guided by a therapist. Treatment is delivered via the Internet.

Therapist-guided Internet-based Cognitive Behavior Therapy

Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided) BEHAVIORAL

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.

Unguided Internet-based Cognitive Behavior Therapy

Cognitive Behavior Therapy, exposure and response prevention (Book, unguided) BEHAVIORAL

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.

Cognitive Behavior Therapy-based bibliotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Location

Related Publications (8)

• 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.

  PMID: 22608115 BACKGROUND

• 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.

  PMID: 12399701 BACKGROUND

• 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.

  PMID: 19416560 BACKGROUND

• 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.

  PMID: 12171378 BACKGROUND

• Furer P, Walker JR. Treatment of Hypochondriasis with Exposure. Journal of Contemporary Psychotherapy 35(3): 251-267, 2005.

  BACKGROUND

• Axelsson E, Osterman S, Hedman-Lagerlof E. Joint factor analysis and approximate equipercentile linking of common trait health anxiety measures: a cross-sectional study of the 14-, 18- and 64-item health anxiety inventory, the illness attitude scale, and the 14-item Whiteley Index. BMC Psychiatry. 2023 Sep 6;23(1):658. doi: 10.1186/s12888-023-05151-7.

  PMID: 37674135 DERIVED

• 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.

  PMID: 29167052 DERIVED

• 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.

  PMID: 27491531 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Erik Hedman, phd

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: phd

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: October 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 5, 2015

Record last verified: 2015-11

Locations

SE (1)