Internet Treatment for Health Anxiety

NCT01673035 | Completed

• 1 other identifier: HA-X
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypochondriasis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• Illness attitude scale (IAS)

  baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up

• Whiteley Index (WI)

  baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up

• Montgomery Åsberg depression rating scale-self report (MADRS-S)

  baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up

• Beck Anxiety Inventory (BAI)

  baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up

• Anxiety Sensitivity Index (ASI)

  baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up

Other Outcomes (1)

• psychological mediators

  week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12

Study Arms (2)

internet-based CBT

EXPERIMENTAL

Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided

Behavioral: CBT, exposure and response prevention

internet-based BSM

ACTIVE COMPARATOR

behavioral stress management delivered via the internet: 12 weeks, therapist-guided

Behavioral: BSM, stress management and applied relaxation

Interventions

CBT, exposure and response prevention BEHAVIORAL

This intervention entails different exercises aimed exposure to health anxiety stimuli.

internet-based CBT

BSM, stress management and applied relaxation BEHAVIORAL

BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.

internet-based BSM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A primary diagnosis of severe health anxiety (hypochondriasis) according to DSM-IV
• At least 18 years old
• Able to read and write in Swedish

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Stockholm County, 17177, Sweden

Location

Related Publications (2)

• 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.

  PMID: 27113231 DERIVED

• 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.

  PMID: 25104835 DERIVED

MeSH Terms

Conditions

Hypochondriasis

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Erik Hedman, phd

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

SE (1)