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Completed

NCT Number: NCT01119469

Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University

Frankfurt am Main, Hesse, D-60486, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Psychotherapy (CT or ET)

Behavioral

weekly 50-minute sessions for 12 weeks

Other names: Cognitive Therapy, Exposure Therapy

Primary outcomes

  1. Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)

    Time frame: 3 months

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

Secondary outcomes

  1. Illness Attitude Scales (IAS)

    Time frame: 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)

    Time frame: 3 months

    self-report measure that assesses depressive symptoms

  3. Beck Anxiety Inventory (BAI)

    Time frame: 3 months

    self-report measure that asessses anxiety symptoms

  4. Brief Symptom Inventory (BSI)

    Time frame: 3 months

    self-report measure that assesses aspects of general psychopathology

  5. Scale for the Assessment of Illness Behavior (SAIB)

    Time frame: 3 months

    self-report measure that focuses on illness behavior

  6. Health-related quality of life (SF-12)

    Time frame: 3 months

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

  7. Cognitions About Body and Health Questionnaire (CABAH)

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Collaborators

  • German Research Foundation

Registry information

Official study title

Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 7, 2010
Registry last updated
Aug 6, 2014

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.

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