Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007
Primary Purpose
Hypochondriasis
Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Cognitive behavioural therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hypochondriasis focused on measuring Hypochondria, Cognitive behavioural therapy, Long term follow-up, Psychosomatics, Psychotherapy
Eligibility 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
Sites / Locations
- Haraldsplass Deaconal Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psychotherapy
Arm Description
Outcomes
Primary Outcome Measures
Level of health anxiety
Secondary Outcome Measures
Health related quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959452
Brief Title
Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007
Official Title
Follow up of Patients Treated With Cognitive Behavioural Therapy at Clinic for Hypochondriacs, Haraldsplass Deaconal Hospital, From 1997 to 2007
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1997 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis
Keywords
Hypochondria, Cognitive behavioural therapy, Long term follow-up, Psychosomatics, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psychotherapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Other Intervention Name(s)
Cognitive therapy
Intervention Description
16 sessions vs 5 sessions of cognitive behavioural therapy
Primary Outcome Measure Information:
Title
Level of health anxiety
Time Frame
10 years follow up
Secondary Outcome Measure Information:
Title
Health related quality of life
Time Frame
10 years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingvard Wilhelmsen, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haraldsplass Deaconal Hospital
City
Bergen
ZIP/Postal Code
5009
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
25149031
Citation
Veddegjaerde KE, Sivertsen B, Wilhelmsen I, Skogen JC. Confirmatory factor analysis and item response theory analysis of the Whiteley Index. Results from a large population based study in Norway. The Hordaland Health Study (HUSK). J Psychosom Res. 2014 Sep;77(3):213-8. doi: 10.1016/j.jpsychores.2014.06.011. Epub 2014 Jun 28.
Results Reference
result
PubMed Identifier
32345417
Citation
Veddegjaerde KF, Sivertsen B, Skogen JC, Smith ORF, Wilhelmsen I. Long-term effect of cognitive-behavioural therapy in patients with Hypochondriacal Disorder. BJPsych Open. 2020 Apr 29;6(3):e42. doi: 10.1192/bjo.2020.22.
Results Reference
result
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Follow up of Patients Treated With Cognitive Behavioural Therapy for Hypochondria From 1997 to 2007
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