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Completed

NCT Number: NCT01673035

Internet Treatment for Health Anxiety

Background

Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.

Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.

Participants in both treatments are expected to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.

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Key information

Conditions

Hypochondriasis Mental Disorders Somatoform Disorders

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

About this study

Background

Severe health anxiety, hypochondriasis according to DSM-IV, is common and associated with functional disability. Cognitive behavior therapy (CBT) and behavioral stress management (BSM) have been showed to be effective in the treatment of severe health anxiety. The mechanisms of the treatments are however poorly understood. In addition, effective psychological treatments are accessible to only a few. One prior RCT has shown that internet-based CBT could be effective in comparison to waiting list controls. More studies on internet-based CBT is essential to establish evidence. In addition, few studies with sufficient power have investigated the effect of CBT in comparison to other active treatments.

Aim of the study The aim of the present RCT is to compare internet-based CBT (n=110) to behavioral stress management (n=110) for adult participants with severe health anxiety. BSM is considered a comparison treatment for two reasons: it has been shown to be effective and it lacks exposure and response prevention, which is suggested to be an important mechanism in CBT.

The investigators expect participants in both treatments to be significantly improved on measures of health anxiety. Participants receiving CBT are expected to be significantly more improved compared to participants receiving BSM.

Design:

Randomized controlled trial. Participants are randomized in a 1:1 ratio.

Assessments:

The primary outcome measure is the Health Anxiety Inventory (HAI). Assessments with HAI are conducted at baseline, post-treatment, 3- and 12 month follow-up.

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 (hypochondriasis) according to DSM-IV
  • 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
  • higher score than 30 on the Montgomery åsberg depression rating scale-self report
  • higher than 3 on the suicide item of the MADRS-S
  • non-stable antidepressant medication during last 2 months if on this kind of medication
  • ongoing concurrent psychological treatment for severe health anxiety
  • having received previous high quality CBT during the recent 3 years
  • ongoing serious somatic disorder

Treatment and study plan

CBT, exposure and response prevention

Behavioral

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

BSM, stress management and applied relaxation

Behavioral

BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.

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 week 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. 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

  7. Sheehan disability scale (SDS)

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

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

  8. 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

  9. Euroqol-5D (EQ-5D)

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

    Change in EQ-5D)I at post-treatment and follow-ups compared to baseline

  10. Obsessive compulsive inventory revised (OCI-R)

    Time frame: baseline

    Only for assessing the sample on this symptom domain at pre-treatment.

  11. Yale-brown obsessive compulsive scale (YBOCS)

    Time frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52

    only for assessing the sample on this domain at pre-treatment

  12. AUDIT (alcohol use)

    Time frame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up

    Change in AUDIT 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, 8, 10, 11, 12

    Assessment of whether these mediators will precede change in outcome during the treatment

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments

Acronym: HA-X

Important dates

Study start
2012
Primary completion
2013
Study completion
2015
First posted
Aug 27, 2012
Registry last updated
Mar 3, 2016

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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