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Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by University of Bergen
Sponsor:
Information provided by (Responsible Party):
Ingvard Wilhelmsen, University of Bergen
ClinicalTrials.gov Identifier:
NCT00959452
First received: August 13, 2009
Last updated: December 2, 2014
Last verified: December 2014
History of Changes
  Purpose

Research has shown that cognitive behavioural therapy is effective in treating hypochondria. However, no studies have examined the long term effect. The investigators have followed 56 patients treated for hypochondria between 1997 and 2001 and the investigators are now doing a 10 year follow-up (Part I). In another part of the study (Part II) the investigators compare the effect of 16 sessions vs. 5 sessions, with a follow-up period of at least 2 years. The investigators hypothesis is that the initial 1 year improvement will be sustained and that 5 sessions will yield the same results as 16 sessions.


Condition Intervention
Hypochondriasis
 Behavioral: Cognitive behavioural therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007

Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Level of health anxiety [ Time Frame: 10 years follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health related quality of life [ Time Frame: 10 years follow-up ] [ Designated as safety issue: No ]
Estimated Enrollment: 250
Study Start Date: January 1997
Estimated Study Completion Date: December 2016
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychotherapy Behavioral: Cognitive behavioural therapy
16 sessions vs 5 sessions of cognitive behavioural therapy
Other Name: Cognitive therapy

Detailed Description:

The follow-up includes a telephone interview by independent researcher and the patients fill in the following questionnaires:

Whiteley Index (measures health anxiety), VAS-scales for health anxiety, worrying about symptoms and body checking, SF-36 (health related quality of life), Giessen Subjective Complaints List, Spielberger Trait and State Anxiety Scale Beck Depression Inventory, Eysenck Personality Questionnaire, General Health Questionnaire (GHQ 28), Somatic Amplification Scale,

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfilling ICD-10 criteria for hypochondriacal disorder

Exclusion Criteria:

  • Unwillingness to participate
  • Substance abuse
  • Serious psychological (f.inst. psychosis, major depression) or somatic (f.inst. cancer) disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959452

Contacts
Contact: Ingvard Wilhelmsen, PhD +47 55979429 Ingvard.Wilhelmsen@med.uib.no
Contact: Kari E Veddegjaerde +47 92088585 karielise@hotmail.com

Locations
Norway
Haraldsplass Deaconal Hospital Recruiting
Bergen, Norway, 5009
Contact: Ingvard Wilhelmsen, PhD    +47 55979429    Ingvard.Wilhelmsen@med.uib.no   
Contact: Kari E Veddegjaerde    +47 92088585    karielise@hotmail.com   
Principal Investigator: Ingvard Wilhelmsen, PhD         
Sponsors and Collaborators
University of Bergen
Investigators
Principal Investigator: Ingvard Wilhelmsen, PhD University of Bergen
  More Information

Publications:

Responsible Party: Ingvard Wilhelmsen, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00959452     History of Changes
Other Study ID Numbers: 17242
Study First Received: August 13, 2009
Last Updated: December 2, 2014
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by University of Bergen:
Hypochondria
Cognitive behavioural therapy
Long term follow-up
Psychosomatics
Psychotherapy

ClinicalTrials.gov processed this record on March 02, 2015