Internet Treatment for Health Anxiety (HA-X)

• Health Anxiety Inventory (HAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]
  Change in HAI 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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
  
  
• Obsessive compulsive inventory revised (OCI-R) [ Time Frame: baseline ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Change in AUDIT at post-treatment and follow-ups compared to baseline.
  
  

• psychological mediators [ Time Frame: week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12 ] [ Designated as safety issue: No ]
  Assessment of whether these mediators will precede change in outcome during the treatment
  
  

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.