Somatization DisorderPhase 2/3NCT00132197
Treatment of Patients With Longstanding Unexplained Health Complaints
A Phase 2/3 study testing Cognitive Behavioral Therapy and Recommendation of care (letter to general practitioner [GP]) in people with Somatization Disorder, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Somatization Disorder
- What is being tested?
- Cognitive Behavioral Therapy and Recommendation of care (letter to general practitioner [GP])
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2005to Sep 2008
- Phase
- Phase 2/3
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Multiple somatic symptoms from several organ systems, without adequate medical explanation.
- Moderate to severe influence on daily life.
- The disorder's functional component can easily be separated from a possible well-defined chronic somatic illness.
- No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (International Classification of Diseases [ICD-10]: F20-29, F30-31, F32.3, F33.3)
- The condition must have been present for at least 2 years.
- Patients of Scandinavian origin who understand, read, write and speak Danish.
Who cannot join
- No informed consent.
- An acute psychiatric disorder that demands other treatment, or if the patient is suicidal.
- Abuse of narcotics or alcohol and (non-prescribed) medicine.
- Pregnancy.
- Current industrial injury case or other action for damages.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.
The purpose of this study is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.
Read the detailed description
Medically unexplained or functional somatic symptoms are complaints, which are not attributable to any verifiable, conventionally defined disease, or which cannot adequately be supported by clinical or para-clinical findings.
Functional somatic symptoms are common in the population and in all clinical settings, both in primary and secondary care. The disorders range from mild, transitory cases, which are difficult to delimit in relation to normality, to severe chronic cases with multiple symptoms from different organ systems.
Chronic multiple functional somatic symptoms often cause frustration for both GPs and patients due to lack of availability of specialized treatment offers. Patients may have a high use of health care, and their social and functional level is low. In Denmark, patients with chronic multiple functional somatic symptoms account for at least 10% of the early retirement pensions each year.
Diverse interventions have been effective in the management and treatment of patients with functional disorders. Care recommendation letters for the GPs have both helped reduce the patients' use of health care and improved their level of physical functioning. Randomized controlled trials (RCT) have shown that cognitive behavioral treatment (CBT) has effect on specific patient groups with functional disorders. Through a combination of cognitive behavioral therapy, social counselling and recommendation letters, it is possible to offer patients with chronic functional somatic symptoms a presumably effective and cost-effective treatment.
- Conditions
- Somatization Disorder
- Being tested
- Cognitive Behavioral Therapy, Recommendation of care (letter to general practitioner [GP])
- Keywords
- Functional somatic symptoms, Cognitive behavioral therapy, somatization disorder, SF-36, cost-effectiveness, Medically unexplained symptoms
- Medical subject headings
- Somatoform Disorders, Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
- Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist.
Recommendation of care (letter to general practitioner [GP])Procedure or surgery
After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities.
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality)
Measured: Measured at baseline and months 4 (end of treatment), 10 and 16
Secondary outcomes (2)
Psychosocial effect measures: Social level of functioning, emotional disorders, coping strategies measured with relevant sub-scales from the SF-36, WHO-DAS II, CSQ, Symptom Checklist SCL, Whiteley-7
Measured: Measured at baseline and months 4 (end of treatment), 10 and 16
Use of health care measured by information from the National Patient Register, the Psychiatric Central Register, the National Health Service Register and The Danish Medicines Agency
Measured: Measured for a period of one year prior to referral (baseline) and a period of one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatization DisorderStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus County, Denmark, Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Per Fink, Dr.Med.Sc., Study director, The Research Clinic for Functional Disorders, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132197
- Sponsor's protocol ID
- 20052
- Status last verified
- Nov 2011
- First submitted
- 19 Jul 2005
- Last updated
- 16 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Schroder A, Rehfeld E, Ornbol E, Sharpe M, Licht RW, Fink P. Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial. Br J Psychiatry. 2012 Jun;200(6):499-507. doi: 10.1192/bjp.bp.111.098681. Epub 2012 Apr 26.
PubMed 22539780
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Chronic Functional Disorders. A Randomized Controlled Trial of Specialized Treatment Compared to Usual Care.
- ClinicalTrials.gov ID
- NCT00132197
- Acronym / sponsor ID
- 20052
- Conditions
- Somatization Disorder
- Keywords
- Functional somatic symptoms, Cognitive behavioral therapy, somatization disorder, SF-36, cost-effectiveness, Medically unexplained symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus County, Denmark, Aarhus University Hospital
- Study start
- Apr 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 19 Aug 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 is to determine the effect of specialized treatment (including cognitive therapy, social counselling and a recommendation letter to the patients' primary care physician) on the functional level, emotional problems, and use of health care in patients with chronic medically unexplained symptoms.
Detailed description
Medically unexplained or functional somatic symptoms are complaints, which are not attributable to any verifiable, conventionally defined disease, or which cannot adequately be supported by clinical or para-clinical findings.
Functional somatic symptoms are common in the population and in all clinical settings, both in primary and secondary care. The disorders range from mild, transitory cases, which are difficult to delimit in relation to normality, to severe chronic cases with multiple symptoms from different organ systems.
Chronic multiple functional somatic symptoms often cause frustration for both GPs and patients due to lack of availability of specialized treatment offers. Patients may have a high use of health care, and their social and functional level is low. In Denmark, patients with chronic multiple functional somatic symptoms account for at least 10% of the early retirement pensions each year.
Diverse interventions have been effective in the management and treatment of patients with functional disorders. Care recommendation letters for the GPs have both helped reduce the patients' use of health care and improved their level of physical functioning. Randomized controlled trials (RCT) have shown that cognitive behavioral treatment (CBT) has effect on specific patient groups with functional disorders. Through a combination of cognitive behavioral therapy, social counselling and recommendation letters, it is possible to offer patients with chronic functional somatic symptoms a presumably effective and cost-effective treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Multiple somatic symptoms from several organ systems, without adequate medical explanation.
- Moderate to severe influence on daily life.
- The disorder's functional component can easily be separated from a possible well-defined chronic somatic illness.
- No lifetime-diagnosis of psychoses, bipolar affective disorder or depression with psychotic symptoms (International Classification of Diseases [ICD-10]: F20-29, F30-31, F32.3, F33.3)
- The condition must have been present for at least 2 years.
Key exclusion criteria (5 listed)
- No informed consent.
- An acute psychiatric disorder that demands other treatment, or if the patient is suicidal.
- Abuse of narcotics or alcohol and (non-prescribed) medicine.
- Pregnancy.
- Current industrial injury case or other action for damages.
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 Therapy1. Specialised treatment includes cognitive groups therapy in 9 modules of 3,5 hours within 3½ months, in all 31,5 hours, consultancy over the phone to the patients' GPs and tuition in groups headed by an experienced social worker. Detailed treatment manuals are worked out separately for each module. Experienced psychotherapists (clinical psychologists and psychiatrists), who also function as consultants, will do the treatment. The Ph.D.-student functions as co-therapist. | Behavioural | – |
| Recommendation of care (letter to general practitioner [GP])After the diagnostic assessment the patient does not receive any treatment offers at the research clinic, but the patient and the GP will be informed about the diagnosis, and the GP will receive advice on further treatment possibilities. | Procedure or surgery | – |
Primary outcome
Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality)
Time frame: Measured at baseline and months 4 (end of treatment), 10 and 16
2 secondary outcomes
Psychosocial effect measures: Social level of functioning, emotional disorders, coping strategies measured with relevant sub-scales from the SF-36, WHO-DAS II, CSQ, Symptom Checklist SCL, Whiteley-7
Time frame: Measured at baseline and months 4 (end of treatment), 10 and 16
Use of health care measured by information from the National Patient Register, the Psychiatric Central Register, the National Health Service Register and The Danish Medicines Agency
Time frame: Measured for a period of one year prior to referral (baseline) and a period of one year after treatment
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 16 Nov 2011.
- Derived from this study: PubMed 22539780Schroder A, Rehfeld E, Ornbol E, Sharpe M, Licht RW, Fink P. Cognitive-behavioural group treatment for a range of functional somatic syndromes: randomised trial. Br J Psychiatry. 2012 Jun;200(6):499-507. doi: 10.1192/bjp.bp.111.098681. Epub 2012 Apr 26.
- Related InfoLink provided by the sponsor.
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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.
Per Fink, Dr.Med.Sc. study director
The Research Clinic for Functional Disorders, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive Behavioral Therapy and Recommendation of care (letter to general practitioner [GP]) in people with Somatization Disorder, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 5 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 16 Nov 2011. 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 Denmark. 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 combined 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.
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?
Physical health measured with The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) (aggregate score of the scales physical functioning, bodily pain and vitality) (time frame: Measured at baseline and months 4 (end of treatment), 10 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00132197, which also lists 1 linked publication.
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 16 Nov 2011.