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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2010 by Karolinska Institutet.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Karolinska Institutet

ClinicalTrials.gov Identifier:

NCT00828152

First received: January 22, 2009

Last updated: June 16, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	January 22, 2009
Last Updated Date	June 16, 2010
Start Date ^ICMJE	January 2009
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 16, 2010)	Health Anxiety Inventory [ Time Frame: 3 days before treatment start ] [ Designated as safety issue: No ] Health Anxiety Inventory [ Time Frame: 12 weeks after pre asessment ] [ Designated as safety issue: No ] Health Anxiety Inventory [ Time Frame: 6 months after post assessment ] [ Designated as safety issue: No ] Health Anxiety Inventory [ Time Frame: 12 months after post assessment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: January 22, 2009)	Health Anxiety Inventory [ Time Frame: Pre, post, 6 and 12 month follow up ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00828152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 16, 2010)	IAS [ Time Frame: Immediately pre and post treatment,and 6 and 12 month follow up ] [ Designated as safety issue: No ] BAI [ Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up ] [ Designated as safety issue: No ] MADRS-S [ Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up ] [ Designated as safety issue: No ] QOLI [ Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up ] [ Designated as safety issue: No ] WI [ Time Frame: Immediately pre and post treatment, and 6 and 12 month follow-up ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: January 22, 2009)	Diagnostic Interview, Instruments to measure anxiety, depression, quality of life. [ Time Frame: pre, post, 6 and 12 month follow up ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety
Official Title ^ICMJE	Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hypochondriasis
Intervention ^ICMJE	Behavioral: Internet-delivered CBT. 12 weeks. Therapist contact through e-mail. Behavioral: On line discussion group Placebo. On line discussion group.
Study Arm (s)	Experimental: 1 Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks. Intervention: Behavioral: Internet-delivered CBT. Placebo Comparator: 2 On line discussion group. Intervention: Behavioral: On line discussion group
Publications *	Hedman E, Andersson E, Lindefors N, Andersson G, Rück C, Ljótsson 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. Hedman E, Andersson G, Andersson E, Ljótsson B, Rück 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	80
Estimated Completion Date	July 2010
Estimated Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Sweden

Administrative Information
NCT Number ^ICMJE	NCT00828152
Other Study ID Numbers ^ICMJE	Ha1b
Has Data Monitoring Committee	No
Responsible Party	Nils Lindefors, Psykiatri Sydväst
Study Sponsor ^ICMJE	Karolinska Institutet
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Karolinska Institutet
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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