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KATHY:Cognitive-behavioural Therapy for Hypochondriasis

Primary Purpose

Hypochondriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Cognitive behavioral psychotherapy
Sponsored by
Copenhagen Trial Unit, Center for Clinical Intervention Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    CBT

    STPP

    Waiting List

    Arm Description

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

    The short-term psychodynamic psychotherapy (STPP).

    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.

    Outcomes

    Primary Outcome Measures

    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

    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).

    Full Information

    First Posted
    September 13, 2005
    Last Updated
    August 10, 2016
    Sponsor
    Copenhagen Trial Unit, Center for Clinical Intervention Research
    Collaborators
    Bispebjerg Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00208247
    Brief Title
    KATHY:Cognitive-behavioural Therapy for Hypochondriasis
    Official Title
    Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2001 (undefined)
    Primary Completion Date
    January 2003 (Actual)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Copenhagen Trial Unit, Center for Clinical Intervention Research
    Collaborators
    Bispebjerg Hospital

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypochondriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT
    Arm Type
    Experimental
    Arm Description
    The cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting.
    Arm Title
    STPP
    Arm Type
    Experimental
    Arm Description
    The short-term psychodynamic psychotherapy (STPP).
    Arm Title
    Waiting List
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive behavioral psychotherapy
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Morten Birket-Smith, DMSc
    Organizational Affiliation
    Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Per Sorensen, MD
    Organizational Affiliation
    Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    KATHY:Cognitive-behavioural Therapy for Hypochondriasis

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