Hypochondriasis
Conditions
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 description
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.
Interventions
BEHAVIORALCBT, exposure and response prevention
This intervention entails different exercises aimed exposure to health anxiety stimuli.
BEHAVIORALBSM, stress management and applied relaxation
BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health Anxiety Inventory (HAI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Sensitivity Index (ASI) | 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 |
| Illness attitude scale (IAS) | 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) | 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) | 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) | 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. |
| Insomnia severity index (ISI) | 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 |
| Trimbos and institute of medical technology assessment cost questionnaire (TIC-P) | 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) | 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) | baseline | Only for assessing the sample on this symptom domain at pre-treatment. |
| Yale-brown obsessive compulsive scale (YBOCS) | 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) | baseline, 12 weeks, 6 month follow-up, 12 month follow-up | Change in AUDIT at post-treatment and follow-ups compared to baseline. |
| Sheehan disability scale (SDS) | baseline, post-treatment (12) 6-month follow-up, 12-month follow-up | Change in SDS at post-treatment and follow-ups compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| psychological mediators | 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 |
Countries
Sweden
Outcome results
None listed