Internet Treatment for Health Anxiety

Hypochondriasis Clinical Trial

— HA-X  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01673035
• Other study ID #: HA-X
• Status: Completed
• Phase: N/A
• First received: August 22, 2012
• Last updated: March 2, 2016
• Start date: September 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: December 2015
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypochondriasis

Intervention

Behavioral:
• CBT, exposure and response prevention
This intervention entails different exercises aimed exposure to health anxiety stimuli.
• BSM, 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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm,	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	psychological mediators	Assessment of whether these mediators will precede change in outcome during the treatment	week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12	No
Primary	Health Anxiety Inventory (HAI)	Change in HAI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up	No
Secondary	Illness attitude scale (IAS)	Change in IAS at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up	No
Secondary	Whiteley Index (WI)	Change in WI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up	No
Secondary	Montgomery Åsberg depression rating scale-self report (MADRS-S)	Change in MADRS-S at post-treatment and follow-ups compared to baseline.	baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up	No
Secondary	Beck Anxiety Inventory (BAI)	Change in BAI at post-treatment and follow-ups compared to baseline.	baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up	No
Secondary	Anxiety Sensitivity Index (ASI)	Change in ASI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up	No
Secondary	Insomnia severity index (ISI)	Change in ISI at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up	No
Secondary	Sheehan disability scale (SDS)	Change in SDS at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12) 6-month follow-up, 12-month follow-up	No
Secondary	Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)	Change in TIC-P at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up	No
Secondary	Euroqol-5D (EQ-5D)	Change in EQ-5D)I at post-treatment and follow-ups compared to baseline	baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up	No
Secondary	Obsessive compulsive inventory revised (OCI-R)	Only for assessing the sample on this symptom domain at pre-treatment.	baseline	No
Secondary	Yale-brown obsessive compulsive scale (YBOCS)	only for assessing the sample on this domain at pre-treatment	Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52	No
Secondary	AUDIT (alcohol use)	Change in AUDIT at post-treatment and follow-ups compared to baseline.	baseline, 12 weeks, 6 month follow-up, 12 month follow-up	No