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KATHY:Cognitive-behavioural Therapy for Hypochondriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00208247
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 11, 2016
Bispebjerg Hospital
Information provided by (Responsible Party):
Copenhagen Trial Unit, Center for Clinical Intervention Research

Brief Summary:
The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis.

Condition or disease Intervention/treatment Phase
Hypochondriasis Behavioral: Cognitive behavioral psychotherapy Phase 2

Detailed Description:

Background: The central feature of hypochondriasis is preoccupation or fear of having a serious disease based on misinterpretation of bodily signs. Psychotherapeutic treatments have developed with focus on different aspects of the condition. Several controlled trials have examined the effectiveness of different treatment strategies.

Hypothesis: Hypochondriasis is accessible for treatment. Specific cognitive treatment focused on misinterpretation of bodily sensations is more effective than short-term non-specific psychodynamic psychotherapy.

Method: Patients with hypochondriasis were randomisation to cognitive behavioural therapy (CBT), psychodynamic psychotherapy, or waiting list. Patients on waiting list were subsequently randomised to CBT or dynamic psychotherapy. The patients received six-teen sessions over a period of six month. Follow-up assessments were made six and twelve month after treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial
Study Start Date : December 2001
Actual Primary Completion Date : January 2003
Actual Study Completion Date : March 2005

Arm Intervention/treatment
Experimental: CBT
The cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting.
Behavioral: Cognitive behavioral psychotherapy
Experimental: STPP
The short-term psychodynamic psychotherapy (STPP).
Behavioral: Cognitive behavioral psychotherapy
Experimental: Waiting List
Patients in the waiting-list group were asked to keep in touch with their GP, who had been informed of the trial in writing. The patients and their GPs were instructed not to begin any other treatment during the study period. After 6 months, the patients on the waiting list were re-evaluated for inclusion and exclusion criteria and, if they still met the criteria, re-randomized to CBT or STPP.
Behavioral: Cognitive behavioral psychotherapy

Primary Outcome Measures :
  1. Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).

Secondary Outcome Measures :
  1. Several secondary outcome measures were included 0, 6 and 12 month after treatment: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Rating Scale for Depression (HAM-D) and Global Assessment Functioning (GAF).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

(1) age between 18 and 65 years, (2) Danish as native language, (3) fulfilment of the ICD-10 research criteria for hypochondriasis (3), (4) health anxiety to a significant degree: a score more than 17 on the health anxiety inventory (HAI) (5).


Exclusion Criteria:

(1) current psychotic condition, (2) current substance abuse, (3) a medical condition which demanded immediate treatment, (4) psychopharmacological treatment initiated or increased during the last 6 weeks before treatment, and (5) previous cognitive behavioural treatment.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00208247

Sponsors and Collaborators
Copenhagen Trial Unit, Center for Clinical Intervention Research
Bispebjerg Hospital
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Study Director: Morten Birket-Smith, DMSc Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark
Principal Investigator: Per Sorensen, MD Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark

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Responsible Party: Copenhagen Trial Unit, Center for Clinical Intervention Research Identifier: NCT00208247     History of Changes
Other Study ID Numbers: 2001-11-DP-82-RKF-21
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Somatoform Disorders
Mental Disorders