Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

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

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

Study Overview

• Status: Completed
• Conditions: Somatoform Disorders; Hypochondriasis
• Intervention / Treatment: Behavioral: Psychotherapy (CT or ET)

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 Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Frankfurt, Hessen, Germany, D-60486
      • Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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: Exposure Therapy; Cognitive 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: Exposure Therapy; Cognitive Therapy
No Intervention: Waiting List (WL); 12 weeks waiting time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)	clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Beck-Depression Inventory II (BDI-II)	self-report measure that assesses depressive symptoms	3 months
Beck Anxiety Inventory (BAI)	self-report measure that asessses anxiety symptoms	3 months
Brief Symptom Inventory (BSI)	self-report measure that assesses aspects of general psychopathology	3 months
Scale for the Assessment of Illness Behavior (SAIB)	self-report measure that focuses on illness behavior	3 months
Health-related quality of life (SF-12)	self-report measure the assesses the health-related quality of life	3 months
Cognitions About Body and Health Questionnaire (CABAH)	self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis	3 months

Collaborators and Investigators

• Sponsor: Goethe University
• Collaborators: German Research Foundation

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: May 5, 2010
• First Submitted That Met QC Criteria: May 6, 2010
• First Posted (Estimate): May 7, 2010

Study Record Updates

• Last Update Posted (Estimate): August 6, 2014
• Last Update Submitted That Met QC Criteria: August 5, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: randomized controlled trial; Cognitive Therapy; Exposure Therapy; Hypochondriasis; Health Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Somatoform Disorders; Hypochondriasis
• Other Study ID Numbers: WE 4654/2-1, WE 4654/2-3