HypochondriasisPhase 3NCT01119469
Comparing Cognitive Therapy and Exposure Therapy in Individuals With Hypochondriasis
A Phase 3 study testing Psychotherapy (CT or ET) in people with Hypochondriasis and Somatoform Disorders, run by Goethe University at 1 site in Germany.
Trial summary
This study will compare the efficacy of cognitive therapy and exposure therapy for treating hypochondriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypochondriasis, Somatoform Disorders
- What is being tested?
- Psychotherapy (CT or ET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2010to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for hypochondriasis
- German fluency and literacy
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy of the Wolfgang Goethe University
Frankfurt am Main, Hesse, D-60486
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypochondriasis, Somatoform Disorders
- Being tested
- Psychotherapy (CT or ET)
- Keywords
- Hypochondriasis, Health Anxiety, randomized controlled trial, Cognitive Therapy, Exposure Therapy
- Medical subject headings
- Hypochondriasis, Somatoform Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapy (CT or ET)Behavioural
Also called Cognitive Therapy, Exposure Therapy
weekly 50-minute sessions for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Therapy (CT) | Experimental | 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. Receives: Behavioral: Psychotherapy (CT or ET) |
| Exposure Therapy (ET) | Experimental | 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. Receives: Behavioral: Psychotherapy (CT or ET) |
| Waiting List (WL) | No intervention | 12 weeks waiting time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)
clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance
Measured: 3 months
Secondary outcomes (7)
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
Measured: 3 months
Beck-Depression Inventory II (BDI-II)
self-report measure that assesses depressive symptoms
Measured: 3 months
Beck Anxiety Inventory (BAI)
self-report measure that asessses anxiety symptoms
Measured: 3 months
Brief Symptom Inventory (BSI)
self-report measure that assesses aspects of general psychopathology
Measured: 3 months
Scale for the Assessment of Illness Behavior (SAIB)
self-report measure that focuses on illness behavior
Measured: 3 months
Health-related quality of life (SF-12)
self-report measure the assesses the health-related quality of life
Measured: 3 months
Cognitions About Body and Health Questionnaire (CABAH)
self-rated measure that focuses on attitudes related to the cognitive concept of hypochondriasis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypochondriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Florian Weck, Goethe University
- Investigators
- Florian Weck, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119469
- Sponsor's protocol ID
- WE 4654/2-1, WE 4654/2-3
- Status last verified
- Aug 2014
- First submitted
- 5 May 2010
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dysfunctional Illness-related Cognitions in Individuals With Hypochondriasis and Change Thereof
- ClinicalTrials.gov ID
- NCT01119469
- Acronym / sponsor ID
- WE 4654/2-1, WE 4654/2-3
- Conditions
- Hypochondriasis, Somatoform Disorders
- Keywords
- Hypochondriasis, Health Anxiety, randomized controlled trial, Cognitive Therapy, Exposure Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Jun 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Therapy (CT) | Experimental | Behavioral: Psychotherapy (CT or 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 psychoeducation, attention training, cognitive restructuring, behavioral experiments, imagery rescripting and relapse prevention. |
| Exposure Therapy (ET) | Experimental | Behavioral: Psychotherapy (CT or 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. |
| Waiting List (WL) | No intervention | –12 weeks waiting time |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets DSM-IV criteria for hypochondriasis
- German fluency and literacy
- Informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychotherapy (CT or ET)Also: Cognitive Therapy, Exposure Therapyweekly 50-minute sessions for 12 weeks | Behavioural | Cognitive Therapy (CT), Exposure Therapy (ET) |
Primary outcome
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS)
Time frame: 3 months
clinician-rated measure that assesses hypochondriacal obsessions, compulsions and avoidance
7 secondary outcomes
Illness Attitude Scales (IAS)
Time frame: 3 months
Beck-Depression Inventory II (BDI-II)
Time frame: 3 months
Beck Anxiety Inventory (BAI)
Time frame: 3 months
Brief Symptom Inventory (BSI)
Time frame: 3 months
Scale for the Assessment of Illness Behavior (SAIB)
Time frame: 3 months
Health-related quality of life (SF-12)
Time frame: 3 months
Cognitions About Body and Health Questionnaire (CABAH)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Related trials for Hypochondriasis
Active, not recruiting
Brief-intensive CBT Versus Once-weekly CBT in Anxiety-related Disorders
Anxiety Disorders, Obsessive-Compulsive Disorder
Recruiting
Evaluation of Primary Care Behavioral Health (PCBH) With the Addition of Self-help CBT - A Randomized Multicenter Trial
Panic Disorder, Social Anxiety Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Weck, PhD principal investigator
Goethe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Psychotherapy (CT or ET) in people with Hypochondriasis and Somatoform Disorders, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypochondriasis Yale-Brown Obsessive-Compulsive Scale (H-YBOCS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.