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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01966705
First Posted: October 22, 2013
Last Update Posted: November 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
October 17, 2013
October 22, 2013
November 5, 2015
October 2013
November 2015   (Final data collection date for primary outcome measure)
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
Health Anxiety Inventory (HAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
Change in HAI at post-treatment and follow-ups compared to baseline
Complete list of historical versions of study NCT01966705 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Illness Attitude Scale (IAS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow- ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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 ]
    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 ]
    Only for assessing the sample on this symptom domain
  • AUDIT (alcohol use) [ 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
  • Insomnia Severity Index (ISI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    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, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    Change in QOLI at post-treatment and follow-ups compared to baseline
  • 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
  • The treatment credibility scale [ Time Frame: Weeks 2 and 8 ]
    For assessing treatment credibility and expectancy of improvement
  • 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
  • The treatment credibility scale [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up, 2 year follow-up, 3 year follow-up, 4 year follow-up, 5 year follow-up, 6 year follow-up ]
    For assessing treatment credibility and expectancy
 
Cognitive Behavior Therapy for Health Anxiety: A Comparison of Three Forms of Self-help
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Severe Health Anxiety
  • Somatic Symptom Disorder
  • Illness Anxiety Disorder
  • 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.

  • 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.

  • 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.

  • Experimental: Therapist-guided Internet-based Cognitive Behavior Therapy
    Cognitive Behavior Therapy delivered via the Internet: 12 weeks, supported self-help
    Intervention: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)
  • Experimental: Unguided Internet-based Cognitive Behavior Therapy
    Cognitive Behavior Therapy delivered via the Internet: 12 weeks, self-help only
    Intervention: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)
  • Experimental: Cognitive Behavior Therapy-based bibliotherapy
    Cognitive Behavior Therapy delivered in book form: 12 weeks, self-help only
    Intervention: Behavioral: Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)
  • No Intervention: Waiting-list condition
    No intervention: 12 weeks

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
132
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01966705
InterBib
Yes
Not Provided
Not Provided
Erik Hedman, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Erik Hedman, phd Karolinska Institutet
Karolinska Institutet
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP