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Completed

NCT Number: NCT02314065

Cognitive Behavioral Therapy for Health Anxiety: Internet Treatment Versus Face-to-Face Therapy

Background

Severe health anxiety is a highly distressing, often debilitating, psychological problem. Since the release of the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) its clinical manifestations are increasingly often referred to as Somatic Symptom Disorder (SSD) or Illness Anxiety Disorder (IAD). Despite often being overlooked in routine care, several treatments for severe health anxiety have shown great promise, the most well-established being Cognitive Behavioral Therapy (CBT). Traditionally, CBT - like most other psychotherapies - has typically been delivered face-to-face. That is, the patient physically meeting with the therapist once a week for the whole of the treatment. Internet-delivered CBT does not rest on this requirement, but has nevertheless been shown to be efficacious for severe health anxiety (see for example NCT01673035).

Aim of the study

The present study aims to compare the effects of Internet-delivered CBT and CBT face-to-face for severe health anxiety in a randomized controlled trial. A non-inferiority criterion is applied to determine if Internet-delivered CBT is at least as efficacious as its well-established predecessor.

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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

Gustavsberg primary care clinic

Gustavsberg, Stockholm County, 13440, 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)
  • Registered citizen of Stockholm county
  • At least 18 years old

Exclusion criteria

  • Other primary axis-I disorder
  • Substance abuse or addiction during the last 6 months
  • Current or previous episode of psychosis or bipolar disorder
  • Severe major depressive disorder
  • Suicide risk
  • Personality disorder making the treatment procedure very difficult
  • Non-stable psychiatric pharmacotherapy (dosage changed during the last 2 months) and the drug is likely to affect outcome measures
  • Ongoing concurrent psychological treatment for severe health anxiety
  • Having received previous high quality Cognitive Therapy or Cognitive Behavioural Therapy during the recent year
  • Ongoing serious somatic disorder, precluding CBT

Treatment and study plan

CBT, exposure and response prevention (Face-to-face)

Behavioral

This intervention entails different exercises aimed at exposure to health anxiety stimuli.

Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week.

CBT, exposure and response prevention (Internet-based)

Behavioral

This intervention entails different exercises aimed at exposure to health anxiety stimuli.

Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system.

Primary outcomes

  1. Health Anxiety Inventory (HAI)

    Time frame: baseline, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up

    Change in HAI at post-treatment and follow-ups compared to baseline. Analyses will be conducted both within an intention-to-treat (ITT) framework and on a complete case basis. A non-inferiority limit of 0.3 d (effect size) will be used.

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. 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

  10. 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

  11. 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

  12. 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

  13. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: Post-treatment (12 weeks)

    For assessing satisfaction with treatment

  14. Sickness Questionnaire (SQ)

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

    Change in SQ at post-treatment and follow-ups compared to baseline

  15. Perceived Vulnerability for Disease (PVD)

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

    Change in PVD at post-treatment and follow-ups compared to baseline

  16. Disgust Scale-Rev (DS-R)

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

    Change in DS-R at post-treatment and follow-ups compared to baseline

  17. WHO Disability Assessment Schedule (WHODAS) 2.0, 12-item version

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

    Change in WHODAS 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, the Insomnia Severity Index, Self-Rated Health 5 and Acceptance/Flexibility. Common health anxiety behaviors will also be assessed.

  2. Credibility/Expectancy scale

    Time frame: Weeks 2 and 8

    For assessing treatment credibility and expectancy of improvement

  3. Working Alliance Inventory (WAI)

    Time frame: Weeks 2 and 8

    For assessing therapeutic alliance

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Cognitive Behavioral Therapy for Health Anxiety: a Randomized Controlled Non-inferiority Trial of Internet-delivered and Face-to-Face Therapy

Acronym: HA-NonInf

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2014
Registry last updated
Oct 29, 2020

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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