Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

Sponsor
Goethe University (Other)
Overall Status
Completed
CT.gov ID
NCT01119469
Collaborator
German Research Foundation (Other)
84
1
3
50
1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychotherapy (CT or ET)
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof
Study Start Date :
Jun 1, 2010
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS) [3 months]

      clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance

    Secondary Outcome Measures

    1. Illness Attitude Scales (IAS) [3 months]

      self-report measure that assesses attitudes, fears, and beliefs associated with the psychopathology of hypochondriasis and that of abnormal illness behavior

    2. Beck-Depression Inventory II (BDI-II) [3 months]

      self-report measure that assesses depressive symptoms

    3. Beck Anxiety Inventory (BAI) [3 months]

      self-report measure that asessses anxiety symptoms

    4. Brief Symptom Inventory (BSI) [3 months]

      self-report measure that assesses aspects of general psychopathology

    5. Scale for the Assessment of Illness Behavior (SAIB) [3 months]

      self-report measure that focuses on illness behavior

    6. Health-related quality of life (SF-12) [3 months]

      self-report measure the assesses the health-related quality of life

    7. Cognitions About Body and Health Questionnaire (CABAH) [3 months]

      self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Florian Weck, PhD, Goethe University
    ClinicalTrials.gov Identifier:
    NCT01119469
    Other Study ID Numbers:
    • WE 4654/2-1, WE 4654/2-3
    First Posted:
    May 7, 2010
    Last Update Posted:
    Aug 6, 2014
    Last Verified:
    Aug 1, 2014
    Keywords provided by Florian Weck, PhD, Goethe University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 6, 2014