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Internet Treatment for Health Anxiety (HA-X)

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ClinicalTrials.gov Identifier: NCT01673035
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Hypochondriasis Behavioral: CBT, exposure and response prevention Behavioral: BSM, stress management and applied relaxation Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy vs. Behavioral Stress Management for Severe Health Anxiety: a Randomized Controlled Trial of Two Internet-based Treatments
Study Start Date : September 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: internet-based CBT
Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided
Behavioral: CBT, exposure and response prevention
This intervention entails different exercises aimed exposure to health anxiety stimuli.

Active Comparator: internet-based BSM
behavioral stress management delivered via the internet: 12 weeks, therapist-guided
Behavioral: 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.




Primary Outcome Measures :
  1. Health Anxiety Inventory (HAI) [ Time Frame: 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 Outcome Measures :
  1. Illness attitude scale (IAS) [ Time Frame: 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

  2. Whiteley Index (WI) [ Time Frame: 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

  3. Montgomery Åsberg depression rating scale-self report (MADRS-S) [ Time Frame: 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.

  4. Beck Anxiety Inventory (BAI) [ Time Frame: 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.

  5. Anxiety Sensitivity Index (ASI) [ Time Frame: 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

  6. Insomnia severity index (ISI) [ Time Frame: 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

  7. Sheehan disability scale (SDS) [ Time Frame: baseline, post-treatment (12) 6-month follow-up, 12-month follow-up ]
    Change in SDS at post-treatment and follow-ups compared to baseline

  8. 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 ]
    Change in TIC-P at post-treatment and follow-ups compared to baseline

  9. Euroqol-5D (EQ-5D) [ Time Frame: 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

  10. Obsessive compulsive inventory revised (OCI-R) [ Time Frame: baseline ]
    Only for assessing the sample on this symptom domain at pre-treatment.

  11. Yale-brown obsessive compulsive scale (YBOCS) [ Time Frame: Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52 ]
    only for assessing the sample on this domain at pre-treatment

  12. AUDIT (alcohol use) [ Time Frame: baseline, 12 weeks, 6 month follow-up, 12 month follow-up ]
    Change in AUDIT at post-treatment and follow-ups compared to baseline.


Other Outcome Measures:
  1. psychological mediators [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673035


Locations
Sweden
Karolinska Institutet
Stockholm,, Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Erik Hedman, phd Karolinska Institutet