Clinical Trial: Internet Treatment for Health Anxiety

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Karolinska Institutet

Current Primary Outcome: 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


Original Primary Outcome: Health Anxiety Inventory (HAI) [ Time Frame: baseline, post-treatment (12 weeks), 3 month follow-up, 12 month follow-up ]

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


Current Secondary Outcome:

  • 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 week 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
  • 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
  • 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
  • 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)I at post-treatment and follow-ups compared to baseline
  • Obsessive compulsive inventory revised (OCI-R) [ Time Frame: baseline ]
    Only for assessing the sample on this symptom domain at pre-treatment.
  • 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
  • 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.


Original Secondary Outcome:

  • Illness attitude scale (IAS) [ Time Frame: baseline, post-treatment (12 weeks), 3-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) 3-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), 3-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 ), 3-month week 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), 3-month follow-up, 12-month follow-up ]
    Change in ASI at post-treatment and follow-ups compared to baseline
  • Insomnia severity index (ISI) [ Time Frame: baseline, post-treatment (12 weeks) 3-month follow-up, 12-month follow-up ]
    Change in ISI at post-treatment and follow-ups compared to baseline
  • Sheehan disability scale (SDS) [ Time Frame: baseline, post-treatment (12) 3-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 ), 3-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), 3-month follow-up, 12-month follow-up ]
    Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
  • Obsessive compulsive inventory revised (OCI-R) [ Time Frame: baseline ]
    Only for assessing the sample on this symptom domain at pre-treatment.
  • 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
  • AUDIT (alcohol use) [ Time Frame: baseline, 12 weeks, 3 month follow-up, 12 month follow-up ]
    Change in AUDIT at post-treatment and follow-ups compared to baseline.


Information By: Karolinska Institutet

Dates:
Date Received: August 22, 2012
Date Started: September 2012
Date Completion:
Last Updated: March 2, 2016
Last Verified: March 2016