KATHY:Cognitive-behavioural Therapy for… | Clinical Trial

Key information

Conditions

Hypochondriasis Mental Disorders Somatoform Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Cognitive behavioral Psychotherapy

Behavioral

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

Copenhagen Trial Unit, Center for Clinical Intervention Research

Other

Collaborators

Bispebjerg Hospital

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2005
First posted: Sep 21, 2005
Registry last updated: Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed