Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Florian Weck, Goethe University
ClinicalTrials.gov Identifier:
NCT01119469
First received: May 5, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis.


Condition Intervention Phase
Hypochondriasis
Somatoform Disorders
Behavioral: Psychotherapy (CT or ET)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof

Resource links provided by NLM:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance


Secondary Outcome Measures:
  • Illness Attitude Scales (IAS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report measure that assesses depressive symptoms

  • Beck Anxiety Inventory (BAI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report measure that asessses anxiety symptoms

  • Brief Symptom Inventory (BSI) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report measure that assesses aspects of general psychopathology

  • Scale for the Assessment of Illness Behavior (SAIB) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report measure that focuses on illness behavior

  • Health-related quality of life (SF-12) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-report measure the assesses the health-related quality of life

  • Cognitions About Body and Health Questionnaire (CABAH) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis


Enrollment: 84
Study Start Date: June 2010
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Therapy (CT)
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.
Behavioral: Psychotherapy (CT or ET)
weekly 50-minute sessions for 12 weeks
Other Names:
  • Cognitive Therapy
  • Exposure Therapy
Experimental: Exposure Therapy (ET)
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.
Behavioral: Psychotherapy (CT or ET)
weekly 50-minute sessions for 12 weeks
Other Names:
  • Cognitive Therapy
  • Exposure Therapy
No Intervention: Waiting List (WL)
12 weeks waiting time

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119469

Locations
Germany
Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University
Frankfurt, Hessen, Germany, D-60486
Sponsors and Collaborators
Goethe University
German Research Foundation
Investigators
Principal Investigator: Florian Weck, PhD Goethe University
  More Information

No publications provided

Responsible Party: Florian Weck, PhD, Goethe University
ClinicalTrials.gov Identifier: NCT01119469     History of Changes
Other Study ID Numbers: WE 4654/2-1, WE 4654/2-3
Study First Received: May 5, 2010
Last Updated: August 5, 2014
Health Authority: Germany: Faculty of Psychology Ethics Committe of the Johann Wolfgang Goethe University

Keywords provided by Goethe University:
Hypochondriasis
Health Anxiety
randomized controlled trial
Cognitive Therapy
Exposure Therapy

Additional relevant MeSH terms:
Hypochondriasis
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014