Clinical trial NCT01119469: Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
Official title: Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypochondriasis
Somatoform Disorders
Keywords: Hypochondriasis
Health Anxiety
randomized controlled trial
Cognitive Therapy
Exposure Therapy
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2010-05-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 criteria: 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

Primary outcomes:
measure: Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)
timeFrame: 3 months
Secondary outcomes:
measure: Illness Attitude Scales (IAS)
timeFrame: 3 months
measure: Beck-Depression Inventory II (BDI-II)
timeFrame: 3 months
measure: Beck Anxiety Inventory (BAI)
timeFrame: 3 months
measure: Brief Symptom Inventory (BSI)
timeFrame: 3 months
measure: Scale for the Assessment of Illness Behavior (SAIB)
timeFrame: 3 months
measure: Health-related quality of life (SF-12)
timeFrame: 3 months
measure: Cognitions About Body and Health Questionnaire (CABAH)
timeFrame: 3 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University
state: Hessen
Study officials:
affiliation: Goethe University
name: Florian Weck, PhD
role: PRINCIPAL_INVESTIGATOR
References: