KATHY:Cognitive-behavioural Therapy for Hypochondriasis

Hypochondriasis Clinical Trial

Official title:

Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00208247
• Other study ID #: 2001-11-DP-82-RKF-21
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: August 10, 2016
• Start date: December 2001
• Est. completion date: March 2005

Study information

• Verified date: August 2016
• Source: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2005
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypochondriasis

Intervention

Behavioral:
• Cognitive behavioral psychotherapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Copenhagen Trial Unit, Center for Clinical Intervention Research	Bispebjerg Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).