Clinical trial NCT01673035: Internet Treatment for Health Anxiety
Official title: Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypochondriasis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-08-27
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Health Anxiety Inventory (HAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Illness attitude scale (IAS)
timeFrame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
measure: Whiteley Index (WI)
timeFrame: baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
measure: Montgomery Åsberg depression rating scale-self report (MADRS-S)
timeFrame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
measure: Anxiety Sensitivity Index (ASI)
timeFrame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
measure: Insomnia severity index (ISI)
timeFrame: baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
measure: Sheehan disability scale (SDS)
timeFrame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
measure: Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
timeFrame: baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
measure: Euroqol-5D (EQ-5D)
timeFrame: baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
measure: Obsessive compulsive inventory revised (OCI-R)
timeFrame: baseline
measure: Yale-brown obsessive compulsive scale (YBOCS)
timeFrame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
measure: AUDIT (alcohol use)
timeFrame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up
Other outcomes:
measure: psychological mediators
timeFrame: week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12
Locations:
city: Stockholm,
country: Sweden
facility: Karolinska Institutet
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedman E, Andersson E, Ljotsson B, Axelsson E, Lekander M. Cost effectiveness of internet-based cognitive behaviour therapy and behavioural stress management for severe health anxiety. BMJ Open. 2016 Apr 25;6(4):e009327. doi: 10.1136/bmjopen-2015-009327.
citation: Hedman E, Axelsson E, Gorling A, Ritzman C, Ronnheden M, El Alaoui S, Andersson E, Lekander M, Ljotsson B. Internet-delivered exposure-based cognitive-behavioural therapy and behavioural stress management for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2014 Oct;205(4):307-14. doi: 10.1192/bjp.bp.113.140913. Epub 2014 Aug 7.