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NCT Number: NCT01966705

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

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.

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Key information

Conditions

Severe Health Anxiety Illness Anxiety Disorder Somatic Symptom Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 22, 2013
Registry last updated
Nov 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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