Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis

NCT ID: NCT01119469

Last Updated: 2014-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2014-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypochondriasis Somatoform Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Psychotherapy (CT or ET)

Intervention Type BEHAVIORAL

weekly 50-minute sessions for 12 weeks

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.

Group Type EXPERIMENTAL

Psychotherapy (CT or ET)

Intervention Type BEHAVIORAL

weekly 50-minute sessions for 12 weeks

Waiting List (WL)

12 weeks waiting time

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Psychotherapy (CT or ET)

weekly 50-minute sessions for 12 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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Cognitive Therapy Exposure Therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role lead

Responsible Party

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Florian Weck

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Florian Weck, PhD

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

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Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Other Identifiers

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WE 4654/2-1, WE 4654/2-3

Identifier Type: -

Identifier Source: org_study_id

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