Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
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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 |
- 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
- 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
| Estimated Enrollment: | 84 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
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:
|
|
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 |
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| Germany | |
| Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University | |
| Frankfurt, Hessen, Germany, D-60486 | |
| 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: | February 7, 2013 |
| 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 May 23, 2013