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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Karolinska Institutet
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01966705
First received: October 17, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Health Anxiety Inventory (HAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in HAI at post-treatment and follow-ups compared to baseline


Secondary Outcome Measures:
  • Illness Attitude Scale (IAS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in IAS at post-treatment and follow-ups compared to baseline

  • Whiteley Index (WI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in WI at post-treatment and follow-ups compared to baseline

  • Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in MADRS-S at post-treatment and follow-ups compared to baseline

  • Beck Anxiety Inventory (BAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in BAI at post-treatment and follow-ups compared to baseline

  • Anxiety Sensitivity Index (ASI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in ASI at post-treatment and follow-ups compared to baseline

  • Sheehan Disability Scale (SDS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in SDS at post-treatment and follow-ups compared to baseline

  • 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 ] [ Designated as safety issue: No ]
    Change in TIC-P at post-treatment and follow-ups compared to baseline

  • Euroqol-5D (EQ-5D) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in EQ-5D at post-treatment and follow-ups compared to baseline

  • Obsessive Compulsive Inventory Revised (OCI-R) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Only for assessing the sample on this symptom domain

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Only for assessing the sample on this symptom domain

  • Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in AUDIT at post-treatment and follow-ups compared to baseline

  • Insomnia Severity Index (ISI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in ISI at post-treatment and follow-ups compared to baseline

  • Self-rated health 5 (SRH-5) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in SRH-5 at post-treatment and follow-ups compared to baseline

  • The Swedish Scales of Personalities [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in The Swedish Scales of Personalities at post-treatment and follow-ups compared to baseline

  • Quality of Life Inventory (QOLI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
    Change in QOLI at post-treatment and follow-ups compared to baseline


Other Outcome Measures:
  • Psychological mediators [ Time Frame: week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 ] [ Designated as safety issue: No ]
    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

  • The treatment credibility scale [ Time Frame: Weeks 2 and 8 ] [ Designated as safety issue: No ]
    For assessing treatment credibility and expectancy of improvement


Estimated Enrollment: 132
Study Start Date: October 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01966705

Locations
Sweden
Karolinska Institutet Recruiting
Stockholm, Sweden, 17177
Contact: Erik Hedman, phd       kire.hedman@ki.se   
Principal Investigator: Erik Hedman, phd         
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Erik Hedman, phd Karolinska Institutet
  More Information

Additional Information:
Publications:
Responsible Party: Erik Hedman, phd, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01966705     History of Changes
Other Study ID Numbers: InterBib
Study First Received: October 17, 2013
Last Updated: October 30, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
severe health anxiety
somatic symptom disorder
illness anxiety disorder
cognitive behavior therapy
bibliotherapy
internet
exposure

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 21, 2014