KATHY:Cognitive-behavioural Therapy for Hypochondriasis

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

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

Study Overview

• Status: Completed
• Conditions: Hypochondriasis
• Intervention / Treatment: Behavioral: Cognitive behavioral psychotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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).

Collaborators and Investigators

• Sponsor: Copenhagen Trial Unit, Center for Clinical Intervention Research
• Collaborators: Bispebjerg Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2001
• Primary Completion (Actual): January 1, 2003
• Study Completion (Actual): March 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): August 11, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Hypochondriasis
• Other Study ID Numbers: 2001-11-DP-82-RKF-21