HypochondriasisPhase 2NCT00208247
KATHY:Cognitive-behavioural Therapy for Hypochondriasis
A Phase 2 study testing Cognitive behavioral psychotherapy in people with Hypochondriasis, run by Copenhagen Trial Unit, Center for Clinical Intervention Research.
Trial summary
The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypochondriasis
- What is being tested?
- Cognitive behavioral psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Dec 2001to Mar 2005
- Phase
- Phase 2
- 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
- age between 18 and 65 years, (2) Danish as native language, (3) fulfilment of the ICD-10 research criteria for hypochondriasis (3), (4) health anxiety to a significant degree: a score more than 17 on the health anxiety inventory (HAI) (5).
- -
Who cannot join
- current psychotic condition, (2) current substance abuse, (3) a medical condition which demanded immediate treatment, (4) psychopharmacological treatment initiated or increased during the last 6 weeks before treatment, and (5) previous cognitive behavioural treatment.
- -
About this study
Official title: Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial
The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis.
Read the detailed description
Background: The central feature of hypochondriasis is preoccupation or fear of having a serious disease based on misinterpretation of bodily signs. Psychotherapeutic treatments have developed with focus on different aspects of the condition. Several controlled trials have examined the effectiveness of different treatment strategies.
Hypothesis: Hypochondriasis is accessible for treatment. Specific cognitive treatment focused on misinterpretation of bodily sensations is more effective than short-term non-specific psychodynamic psychotherapy.
Method: Patients with hypochondriasis were randomisation to cognitive behavioural therapy (CBT), psychodynamic psychotherapy, or waiting list. Patients on waiting list were subsequently randomised to CBT or dynamic psychotherapy. The patients received six-teen sessions over a period of six month. Follow-up assessments were made six and twelve month after treatment.
- Conditions
- Hypochondriasis
- Being tested
- Cognitive behavioral psychotherapy
- Medical subject headings
- Hypochondriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral psychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | The cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting. Receives: Behavioral: Cognitive behavioral psychotherapy |
| STPP | Experimental | The short-term psychodynamic psychotherapy (STPP). Receives: Behavioral: Cognitive behavioral psychotherapy |
| Waiting List | Experimental | Patients in the waiting-list group were asked to keep in touch with their GP, who had been informed of the trial in writing. The patients and their GPs were instructed not to begin any other treatment during the study period. After 6 months, the patients on the waiting list were re-evaluated for inclusion and exclusion criteria and, if they still met the criteria, re-randomized to CBT or STPP. Receives: Behavioral: Cognitive behavioral psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).
Secondary outcomes (1)
Several secondary outcome measures were included 0, 6 and 12 month after treatment: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Rating Scale for Depression (HAM-D) and Global Assessment Functioning (GAF).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2001
- Primary completionJan 2003
- Study completionMar 2005
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention Research
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- Morten Birket-Smith, DMSc, Study director, Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, DenmarkPer Sorensen, MD, Principal investigator, Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208247
- Sponsor's protocol ID
- 2001-11-DP-82-RKF-21
- Status last verified
- Aug 2016
- First submitted
- 13 Sep 2005
- Last updated
- 11 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive-behavioural Therapy Versus Short-term Psychodynamic Psychotherapy: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT00208247
- Acronym / sponsor ID
- 2001-11-DP-82-RKF-21
- Conditions
- Hypochondriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Copenhagen Trial Unit, Center for Clinical Intervention ResearchUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Dec 2001
- Primary completion
- Jan 2003 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Sep 2005 (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.
The purpose of this study was to examined if psychotherapy is an effecitive treatment for hypochondriasis.
Detailed description
Background: The central feature of hypochondriasis is preoccupation or fear of having a serious disease based on misinterpretation of bodily signs. Psychotherapeutic treatments have developed with focus on different aspects of the condition. Several controlled trials have examined the effectiveness of different treatment strategies.
Hypothesis: Hypochondriasis is accessible for treatment. Specific cognitive treatment focused on misinterpretation of bodily sensations is more effective than short-term non-specific psychodynamic psychotherapy.
Method: Patients with hypochondriasis were randomisation to cognitive behavioural therapy (CBT), psychodynamic psychotherapy, or waiting list. Patients on waiting list were subsequently randomised to CBT or dynamic psychotherapy. The patients received six-teen sessions over a period of six month. Follow-up assessments were made six and twelve month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: Cognitive behavioral psychotherapyThe cognitive behavioural treatment developed by Salkovskis, Warwick and co-workers was used, with adaptations for the specific setting. |
| STPP | Experimental | Behavioral: Cognitive behavioral psychotherapyThe short-term psychodynamic psychotherapy (STPP). |
| Waiting List | Experimental | Behavioral: Cognitive behavioral psychotherapyPatients in the waiting-list group were asked to keep in touch with their GP, who had been informed of the trial in writing. The patients and their GPs were instructed not to begin any other treatment during the study period. After 6 months, the patients on the waiting list were re-evaluated for inclusion and exclusion criteria and, if they still met the criteria, re-randomized to CBT or STPP. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 65 years, (2) Danish as native language, (3) fulfilment of the ICD-10 research criteria for hypochondriasis (3), (4) health anxiety to a significant degree: a score more than 17 on the health anxiety inventory (HAI) (5).
- -
Key exclusion criteria (2 listed)
- current psychotic condition, (2) current substance abuse, (3) a medical condition which demanded immediate treatment, (4) psychopharmacological treatment initiated or increased during the last 6 weeks before treatment, and (5) previous cognitive behavioural treatment.
- -
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 |
|---|---|---|
| Cognitive behavioral psychotherapy | Behavioural | CBT, STPP, Waiting List |
Primary outcome
Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).
1 secondary outcome
Several secondary outcome measures were included 0, 6 and 12 month after treatment: Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Hamilton Rating Scale for Depression (HAM-D) and Global Assessment Functioning (GAF).
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 11 Aug 2016.
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.
Morten Birket-Smith, DMSc study director
Liaison Psychiatric Unit, Bispebjerg Hospital, 2400 NV Copenhagen, Denmark
Per Sorensen, MD principal investigator
Liaison Psychiatric Unit, Bispebjerg Hospital, 2400-NV Copenhagen, Denmark
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive behavioral psychotherapy in people with Hypochondriasis, run by Copenhagen Trial Unit, Center for Clinical Intervention Research.
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 2 inclusion and 2 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Two primary outcome measures were included 0, 6 and 12 month after treatment: the Health Anxiety Inventory (HAI), which is an 18-item, self-report questionnaire and the Hamilton Anxiety Rating Scale (HAM-A).. 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 11 Aug 2016.