Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

Somatoform Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01119469
• Other study ID #: WE 4654/2-1, WE 4654/2-3
• Status: Completed
• Phase: Phase 3
• First received: May 5, 2010
• Last updated: August 5, 2014
• Start date: June 2010
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Faculty of Psychology Ethics Committe of the Johann Wolfgang Goethe University
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypochondriasis
• Somatoform Disorders

Intervention

Behavioral:
• Psychotherapy (CT or ET)
weekly 50-minute sessions for 12 weeks

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University	Frankfurt	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Goethe University	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)	clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance	3 months	No
Secondary	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	3 months	No
Secondary	Beck-Depression Inventory II (BDI-II)	self-report measure that assesses depressive symptoms	3 months	No
Secondary	Beck Anxiety Inventory (BAI)	self-report measure that asessses anxiety symptoms	3 months	No
Secondary	Brief Symptom Inventory (BSI)	self-report measure that assesses aspects of general psychopathology	3 months	No
Secondary	Scale for the Assessment of Illness Behavior (SAIB)	self-report measure that focuses on illness behavior	3 months	No
Secondary	Health-related quality of life (SF-12)	self-report measure the assesses the health-related quality of life	3 months	No
Secondary	Cognitions About Body and Health Questionnaire (CABAH)	self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis	3 months	No