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Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety (Ha1b)

Primary Purpose

Hypochondriasis

Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Internet-delivered CBT.
On line discussion group
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:

  • Primary diagnosis of hypochondriasis
  • At least 18 years old
  • Able to read and write in swedish
  • Computer access

Exclusion Criteria:

  • Drug abuse
  • Concurrent severe depression
  • No serious somatic illness
  • Previous treatment with CBT for hypochondriasis

Sites / Locations

  • Psykiatri Sydväst

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks.

On line discussion group.

Outcomes

Primary Outcome Measures

Health Anxiety Inventory
Health Anxiety Inventory
Health Anxiety Inventory
Health Anxiety Inventory

Secondary Outcome Measures

IAS
BAI
MADRS-S
QOLI
WI

Full Information

First Posted
January 22, 2009
Last Updated
May 5, 2015
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT00828152
Brief Title
Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety
Acronym
Ha1b
Official Title
Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.

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
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
On line discussion group.
Intervention Type
Behavioral
Intervention Name(s)
Internet-delivered CBT.
Intervention Description
12 weeks. Therapist contact through e-mail.
Intervention Type
Behavioral
Intervention Name(s)
On line discussion group
Intervention Description
Placebo. On line discussion group.
Primary Outcome Measure Information:
Title
Health Anxiety Inventory
Time Frame
3 days before treatment start
Title
Health Anxiety Inventory
Time Frame
12 weeks after pre asessment
Title
Health Anxiety Inventory
Time Frame
6 months after post assessment
Title
Health Anxiety Inventory
Time Frame
12 months after post assessment
Secondary Outcome Measure Information:
Title
IAS
Time Frame
Immediately pre and post treatment,and 6 and 12 month follow up
Title
BAI
Time Frame
Immediately pre and post treatment, and 6 and 12 month follow-up
Title
MADRS-S
Time Frame
Immediately pre and post treatment, and 6 and 12 month follow-up
Title
QOLI
Time Frame
Immediately pre and post treatment, and 6 and 12 month follow-up
Title
WI
Time Frame
Immediately pre and post treatment, and 6 and 12 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of hypochondriasis At least 18 years old Able to read and write in swedish Computer access Exclusion Criteria: Drug abuse Concurrent severe depression No serious somatic illness Previous treatment with CBT for hypochondriasis
Facility Information:
Facility Name
Psykiatri Sydväst
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25437150
Citation
Hedman E, Andersson G, Lindefors N, Gustavsson P, Lekander M, Ruck C, Andersson E, Ljotsson B. Personality change following internet-based cognitive behavior therapy for severe health anxiety. PLoS One. 2014 Dec 1;9(12):e113871. doi: 10.1371/journal.pone.0113871. eCollection 2014.
Results Reference
derived
PubMed Identifier
22608115
Citation
Hedman E, Andersson E, Lindefors N, Andersson G, Ruck C, Ljotsson B. Cost-effectiveness and long-term effectiveness of internet-based cognitive behaviour therapy for severe health anxiety. Psychol Med. 2013 Feb;43(2):363-74. doi: 10.1017/S0033291712001079. Epub 2012 May 21.
Results Reference
derived
PubMed Identifier
21357882
Citation
Hedman E, Andersson G, Andersson E, Ljotsson B, Ruck C, Asmundson GJ, Lindefors N. Internet-based cognitive-behavioural therapy for severe health anxiety: randomised controlled trial. Br J Psychiatry. 2011 Mar;198(3):230-6. doi: 10.1192/bjp.bp.110.086843.
Results Reference
derived

Learn more about this trial

Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety

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