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Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

Primary Purpose

Hypochondriasis, Somatoform Disorders

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Psychotherapy (CT or ET)
Sponsored by
Goethe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypochondriasis focused on measuring Hypochondriasis, Health Anxiety, randomized controlled trial, Cognitive Therapy, Exposure Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Meets DSM-IV criteria for hypochondriasis
  • German fluency and literacy
  • Informed consent

Exclusion Criteria:

  • Major medical illness expected to worsen significantly
  • Currently in psychotherapy
  • Suicidal tendency
  • Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Cognitive Therapy (CT)

Exposure Therapy (ET)

Waiting List (WL)

Arm Description

There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention.

There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include change of safety behavior, exposition (in sensu and in vivo), and response prevention.

12 weeks waiting time

Outcomes

Primary Outcome Measures

Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)
clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance

Secondary Outcome Measures

Illness Attitude Scales (IAS)
self-report measure that assesses attitudes, fears, and beliefs associated with the psychopathology of hypochondriasis and that of abnormal illness behavior
Beck-Depression Inventory II (BDI-II)
self-report measure that assesses depressive symptoms
Beck Anxiety Inventory (BAI)
self-report measure that asessses anxiety symptoms
Brief Symptom Inventory (BSI)
self-report measure that assesses aspects of general psychopathology
Scale for the Assessment of Illness Behavior (SAIB)
self-report measure that focuses on illness behavior
Health-related quality of life (SF-12)
self-report measure the assesses the health-related quality of life
Cognitions About Body and Health Questionnaire (CABAH)
self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis

Full Information

First Posted
May 5, 2010
Last Updated
August 5, 2014
Sponsor
Goethe University
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01119469
Brief Title
Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
Official Title
Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Goethe University
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.
Detailed Description
Hypochondriasis is defined as a preoccupation with the fear of having a serious disease based on the person's misinterpretation of bodily symptoms (APA). For a long time hypochondriasis was seen as difficult to treat. Meanwhile effective psychological treatment for hypochondriasis exists. Psychotherapies using cognitive therapy (CT), cognitive behavioral therapy (CBT), exposure therapy (ET) or behavioral stress management approaches are effective in reducing symptoms of hypochondriasis. However, few studies compare different types of psychotherapy. In addition, in these studies numbers of participants were small, no differences between different treatments were found, and one third of the participants showed no satisfactory change. This study will compare the efficacy of CT and ET in a larger sample of 84 participants. Participants in this randomized controlled trial (RCT) will first undergo baseline assessment. Then they will be randomly assigned to either CT, ET or a waiting list (WL), all conditions are for the duration of 12 weeks. CT includes psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention. ET includes change of safety behavior, exposition (in sensu and in vivo), and relapse prevention. Both treatment trials contain the identical number of sessions. Treatment response will be assessed at week 12 and additionally one and three years after treatment. Participants of the WL will be assigned to CT or ET after the waiting period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypochondriasis, Somatoform Disorders
Keywords
Hypochondriasis, Health Anxiety, randomized controlled trial, Cognitive Therapy, Exposure Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Therapy (CT)
Arm Type
Experimental
Arm Description
There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention.
Arm Title
Exposure Therapy (ET)
Arm Type
Experimental
Arm Description
There will be 12 50-minute individual sessions conducted at weekly intervals. Booster sessions will be conducted one, three and six months after treatment. Sessions include change of safety behavior, exposition (in sensu and in vivo), and response prevention.
Arm Title
Waiting List (WL)
Arm Type
No Intervention
Arm Description
12 weeks waiting time
Intervention Type
Behavioral
Intervention Name(s)
Psychotherapy (CT or ET)
Other Intervention Name(s)
Cognitive Therapy, Exposure Therapy
Intervention Description
weekly 50-minute sessions for 12 weeks
Primary Outcome Measure Information:
Title
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)
Description
clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Illness Attitude Scales (IAS)
Description
self-report measure that assesses attitudes, fears, and beliefs associated with the psychopathology of hypochondriasis and that of abnormal illness behavior
Time Frame
3 months
Title
Beck-Depression Inventory II (BDI-II)
Description
self-report measure that assesses depressive symptoms
Time Frame
3 months
Title
Beck Anxiety Inventory (BAI)
Description
self-report measure that asessses anxiety symptoms
Time Frame
3 months
Title
Brief Symptom Inventory (BSI)
Description
self-report measure that assesses aspects of general psychopathology
Time Frame
3 months
Title
Scale for the Assessment of Illness Behavior (SAIB)
Description
self-report measure that focuses on illness behavior
Time Frame
3 months
Title
Health-related quality of life (SF-12)
Description
self-report measure the assesses the health-related quality of life
Time Frame
3 months
Title
Cognitions About Body and Health Questionnaire (CABAH)
Description
self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis
Time Frame
3 months

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: Meets DSM-IV criteria for hypochondriasis German fluency and literacy Informed consent Exclusion Criteria: Major medical illness expected to worsen significantly Currently in psychotherapy Suicidal tendency Clinical diagnosis of alcohol or drug addiction, schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florian Weck, PhD
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
D-60486
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

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