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Internet Treatment for Health Anxiety (HA-X)

Primary Purpose

Hypochondriasis

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBT, exposure and response prevention
BSM, stress management and applied relaxation
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska Institutet

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

internet-based CBT

internet-based BSM

Arm Description

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

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

Outcomes

Primary Outcome Measures

Health Anxiety Inventory (HAI)
Change in HAI at post-treatment and follow-ups compared to baseline

Secondary Outcome Measures

Illness attitude scale (IAS)
Change in IAS at post-treatment and follow-ups compared to baseline
Whiteley Index (WI)
Change in WI at post-treatment and follow-ups compared to baseline
Montgomery Åsberg depression rating scale-self report (MADRS-S)
Change in MADRS-S at post-treatment and follow-ups compared to baseline.
Beck Anxiety Inventory (BAI)
Change in BAI at post-treatment and follow-ups compared to baseline.
Anxiety Sensitivity Index (ASI)
Change in ASI at post-treatment and follow-ups compared to baseline
Insomnia severity index (ISI)
Change in ISI at post-treatment and follow-ups compared to baseline
Sheehan disability scale (SDS)
Change in SDS at post-treatment and follow-ups compared to baseline
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Change in TIC-P at post-treatment and follow-ups compared to baseline
Euroqol-5D (EQ-5D)
Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
Obsessive compulsive inventory revised (OCI-R)
Only for assessing the sample on this symptom domain at pre-treatment.
Yale-brown obsessive compulsive scale (YBOCS)
only for assessing the sample on this domain at pre-treatment
AUDIT (alcohol use)
Change in AUDIT at post-treatment and follow-ups compared to baseline.

Full Information

First Posted
August 22, 2012
Last Updated
March 2, 2016
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01673035
Brief Title
Internet Treatment for Health Anxiety
Acronym
HA-X
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
178 (Actual)

8. Arms, Groups, and Interventions

Arm Title
internet-based CBT
Arm Type
Experimental
Arm Description
Cognitive behavior therapy delivered via the internet: 12 weeks, therapist-guided
Arm Title
internet-based BSM
Arm Type
Active Comparator
Arm Description
behavioral stress management delivered via the internet: 12 weeks, therapist-guided
Intervention Type
Behavioral
Intervention Name(s)
CBT, exposure and response prevention
Intervention Description
This intervention entails different exercises aimed exposure to health anxiety stimuli.
Intervention Type
Behavioral
Intervention Name(s)
BSM, stress management and applied relaxation
Intervention Description
BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.
Primary Outcome Measure Information:
Title
Health Anxiety Inventory (HAI)
Description
Change in HAI at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Secondary Outcome Measure Information:
Title
Illness attitude scale (IAS)
Description
Change in IAS at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Title
Whiteley Index (WI)
Description
Change in WI at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks) 6-month follow-up, 12 month follow-up
Title
Montgomery Åsberg depression rating scale-self report (MADRS-S)
Description
Change in MADRS-S at post-treatment and follow-ups compared to baseline.
Time Frame
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Title
Beck Anxiety Inventory (BAI)
Description
Change in BAI at post-treatment and follow-ups compared to baseline.
Time Frame
baseline, post-treatment (12 weeks ), 6-month week follow-up, 12-month follow-up
Title
Anxiety Sensitivity Index (ASI)
Description
Change in ASI at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Title
Insomnia severity index (ISI)
Description
Change in ISI at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks) 6-month follow-up, 12-month follow-up
Title
Sheehan disability scale (SDS)
Description
Change in SDS at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12) 6-month follow-up, 12-month follow-up
Title
Trimbos and institute of medical technology assessment cost questionnaire (TIC-P)
Description
Change in TIC-P at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks ), 6-month follow-up, 12-month follow-up
Title
Euroqol-5D (EQ-5D)
Description
Change in EQ-5D)I at post-treatment and follow-ups compared to baseline
Time Frame
baseline, post-treatment (12 weeks), 6-month follow-up, 12-month follow-up
Title
Obsessive compulsive inventory revised (OCI-R)
Description
Only for assessing the sample on this symptom domain at pre-treatment.
Time Frame
baseline
Title
Yale-brown obsessive compulsive scale (YBOCS)
Description
only for assessing the sample on this domain at pre-treatment
Time Frame
Baseline, post-treatment (variable depending on disorder), weeks 26, weeks 52
Title
AUDIT (alcohol use)
Description
Change in AUDIT at post-treatment and follow-ups compared to baseline.
Time Frame
baseline, 12 weeks, 6 month follow-up, 12 month follow-up
Other Pre-specified Outcome Measures:
Title
psychological mediators
Description
Assessment of whether these mediators will precede change in outcome during the treatment
Time Frame
week 1, 2, 3, 4, 5, 6, 7, 8, 8, 10, 11, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hedman, phd
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm,
State/Province
Stockholm
ZIP/Postal Code
17177
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27113231
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.
Results Reference
derived
PubMed Identifier
25104835
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.
Results Reference
derived

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Internet Treatment for Health Anxiety

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