KATHY:Cognitive-behavioural Therapy for Hypochondriasis

NCT ID: NCT00208247

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2005-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypochondriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CBT

The cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting.

Group Type EXPERIMENTAL

Cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

STPP

The short-term psychodynamic psychotherapy (STPP).

Group Type EXPERIMENTAL

Cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

Interventions

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Cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

Copenhagen Trial Unit, Center for Clinical Intervention Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morten Birket-Smith, DMSc

Role: STUDY_DIRECTOR

Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark

Per Sorensen, MD

Role: PRINCIPAL_INVESTIGATOR

Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark

Other Identifiers

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2001-11-DP-82-RKF-21

Identifier Type: -

Identifier Source: org_study_id

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