Medically Unexplained SymptomsPsySomNCT01935258
Psychosomatic Therapy, Feasibility and Cost Analysis
A study testing Psychosomatic therapy and care as usual in people with Medically Unexplained Symptoms and Psychosomatic Therapy, run by Radboud University Medical Center at 8 sites in Netherlands.
Trial summary
Medically unexplained symptoms (MUS) are a common and important problem in primary care. Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful tests, referrals and treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Medically Unexplained Symptoms, Psychosomatic Therapy
- What is being tested?
- Psychosomatic therapy and care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesNetherlands
- Study dates
- Apr 2013to Feb 2015
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with medical unexplained symptoms who consulting the general practitioner more than once for one or more of the 12 most common symptoms:
- stomach-/abdominal pain,
- back/neck/shoulder pain,
- pain in arms/legs/joints,
- headache, chest pain,
- dizziness,
Show all 12Show fewer
- fainting spells,
- palpitations of the heart,
- shortness of breath,
- nausea/indigestion,
- feeling tired,
- sleeping disorder and psychosocial distress
Who cannot join
- patients wich chronic diseases,
- palliative care,
- severe psychiatric disorders,
- long-lasting injury treatment
- patients who are not able to speak, read and write Dutch
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Netherlands8 sites
General Practitioner, Douwes Dekker
Albergen, Overijssel, 7665 AP
General Practitioner, Hesselink
Borne, Overijssel, Borne
M. Oijevaar
Borne, 7622DE
General Practitioner,Tuijnenburg
Enschede, Overijssel, 7543 EH
General Practitioner, Kleissen
Haaksbergen, Overijssel, 7482 AR
General Practitioner, van der Waart
Hengelo, Overijssel, 7559 NM
D.J. Jansen
Julianadorp, 1787AE
General Practitioner, Van Rijn
Vriezenveen, Overijssel, 7672 GD
About this study
Official title: Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial
Medically unexplained symptoms (MUS) are a common and important problem in primary care. Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful tests, referrals and treatment. Evidence indicate that specific interventions for patients with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited help. According to experts in this field a multi-component approach is most helpful for these patients.
This pilot trial aims to test the systematic identification of eligible patients, to assess the acceptability of the intervention and to estimate potential treatment effects for a larger trial.
Read more
It's a randomised pilot study consisting of patients with MUS in primary care. Patients will be randomized to intervention (usual care and additional psychosomatic therapy) or control condition (usual care alone). Patients will be followed for one year.
Participants are patients consulting their GP more than once with MUS and in which the GP presumes that psychosocial distress is an underlying cause.
The intervention is the psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS.
Primary outcome measures are: the number of patients identified and recruited, perceived symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom Questionnaire). Other primary outcome measures are the time needed to include the eligible patients, the number of withdrawals in the intervention and control group, compliance in the therapy group and the number of patients who complete the questionnaires.
Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation List), physical and mental health status and quality of life (SF-36), and level of functioning (MAF: measure of general functioning). Patient satisfaction with the received therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the Cost Diary for medical consumption.
Read the detailed description
Recruitment and signed informed consent:Participating GPs (n=6) were asked to enrol each consecutive eligible patient and include 10 patients with MUS each. The GPs presented written information and an informed consent form to these patients. Patients had the opportunity to read the information to consider participation before signing the consent form.
Randomisation: Participating patients (n=60) are equally randomised over two groups, the intervention group (usual care and psychosomatic therapy delivered by a psychosomatic therapist) and the control group (usual care of the GP). For the randomisation we used a random number table, whereas a central and blinded allocation procedure was applied.For the randomisation we used a random number table, whereas a central and blinded allocation procedure was applied.
Patients in the intervention group were asked to complete a questionnaire at baseline, at the end of the intervention (+/- 3 months)and at 6 and 12 months. Patients in the control group completed a questionnaire at baseline, at 3 (equals end of intervention), 6 and 12 months.
Statistical analysis The number of patients identified and recruited by the GP as well as the number of eligible patients who declined to enter the trial were analysed using descriptive statistics. Furthermore, at each stage of the study, we recorded the number of trial participants who completed the study.
The effects of the intervention on the primary outcome measures (VAS and 4DSQ) and the secondary outcome measures (NHL, SF-36 and MAF) were estimated using analysis of covariance with baseline value as a covariate. Data analysis was be performed according to the intention-to-treat principle. Medical consumption was measured using the Cost Diary for medical consumption. Patients recorded their absenteeism and healthcare consumption, such as consulting a GP, hospital, paramedic facilities and alternative medicine. Medication intake was recorded at the start and the end of the study. We used standardised Dutch prices (guide cost research 2009), whereas medication costs were calculated according to the Dutch Pharmaco Therapeutic Compass. Costs by absenteeism were calculated according to the Friction Cost method.
Difference in cost of medical consumption between the control and intervention group were estimated using analysis of covariance with baseline value as a covariate.
Difference in baseline characteristics were analysed with the student's t-test for continue variables and the chi-squared test or Fisher's exact test for categorical variables. P-values of < 0.05 were considered statistical significant.
- Being tested
- Psychosomatic therapy, care as usual
- Keywords
- Medically unexplained symptoms, Somatization, Psychosomatic therapy
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosomatic therapyOther
Psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS.
care as usualOther
usual care of the general practitioner
| Study group | Role | What they receive |
|---|---|---|
| Psychosomatic therapy | Experimental | Psychosomatic therapy consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. Psychosomatic therapy delivered by a psychosomatic therapist. Receives: Other: Psychosomatic therapy; Other: care as usual |
| care as usual | Other | Usual care of the general practitioner Receives: Other: care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients identified and recruited
The number of patients identified and recruited by the GP
Measured: one year
The time needed to include the eligible patients
The time needed to include the eligible patients by the GPs
Measured: one year
The number of withdrawals in both groups
the number of patients that withdraw from the study in both groups
Measured: one year
Perceived symptom severity
Perceived symptoms severity by patients
Measured: one year
Patients' self-rated symptoms of distress, depression, anxiety and somatization
Patients' self-rated symptoms of distress, depression, anxiety ansd somatization measured with the Four Dimensional Symptom Questionnaire (4DSQ)
Measured: one year
Secondary outcomes (3)
Symptoms of hyperventilation
symptoms of hyperventilation measured by the NHL (Nijmegen Hyperventilation List) according to patients
Measured: at baseline, at 3, 6 and 12 months
Physical and mental status and quality of life
Physical and mental health status and quality of life according to patients are measured by the SF-36
Measured: at baseline, at 3, 6 and 12 months
Level of functioning
Level of functioning according to patients are measured by the MAF (measure of general functioning)
Measured: at baseline, at 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2014
- Study completionFeb 2015
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 Medically Unexplained SymptomsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim olde Hartman, Radboud University Medical Center
- Investigators
- Tim C. olde Hartman, MD Phd, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935258
- Sponsor's protocol ID
- 2012/365
- Acronym
- PsySom
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2013
- Last updated
- 4 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wortman MS, Lucassen PL, van Ravesteijn HJ, Bor H, Assendelft PJ, Lucas C, Olde Hartman TC. Brief multimodal psychosomatic therapy in patients with medically unexplained symptoms: feasibility and treatment effects. Fam Pract. 2016 Aug;33(4):346-53. doi: 10.1093/fampra/cmw023. Epub 2016 Apr 13.
PubMed 27075027
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial
- ClinicalTrials.gov ID
- NCT01935258
- Acronym / sponsor ID
- PsySom / 2012/365
- Keywords
- Medically unexplained symptoms, Somatization, Psychosomatic therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Sep 2013 (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.
Medically unexplained symptoms (MUS) are a common and important problem in primary care. Patients repeatedly presenting MUS to their general practitioner (GP) suffer from their symptoms, are functionally impaired, and are at risk of unnecessary and possibly harmful tests, referrals and treatment. Evidence indicate that specific interventions for patients with MUS, such as reattribution therapy and cognitive behavioural therapy are of limited help. According to experts in this field a multi-component approach is most helpful for these patients.
This pilot trial aims to test the systematic identification of eligible patients, to assess the acceptability of the intervention and to estimate potential treatment effects for a larger trial.
It's a randomised pilot study consisting of patients with MUS in primary care. Patients will be randomized to intervention (usual care and additional psychosomatic therapy) or control condition (usual care alone). Patients will be followed for one year.
Participants are patients consulting their GP more than once with MUS and in which the GP presumes that psychosocial distress is an underlying cause.
The intervention is the psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS.
Primary outcome measures are: the number of patients identified and recruited, perceived symptom severity, measured on a Visual Analogue Scale (VAS) and patients' self-rated symptoms of distress, depression, anxiety and somatization (4DSQ: The Four Dimensional Symptom Questionnaire). Other primary outcome measures are the time needed to include the eligible patients, the number of withdrawals in the intervention and control group, compliance in the therapy group and the number of patients who complete the questionnaires.
Secondary outcome measures are: symptoms of hyperventilation (NHL: Nijmegen Hyperventilation List), physical and mental health status and quality of life (SF-36), and level of functioning (MAF: measure of general functioning). Patient satisfaction with the received therapy is rated on a 5-point Likert-type scale. Medical consumption will be measured by the Cost Diary for medical consumption.
Detailed description
Recruitment and signed informed consent:Participating GPs (n=6) were asked to enrol each consecutive eligible patient and include 10 patients with MUS each. The GPs presented written information and an informed consent form to these patients. Patients had the opportunity to read the information to consider participation before signing the consent form.
Randomisation: Participating patients (n=60) are equally randomised over two groups, the intervention group (usual care and psychosomatic therapy delivered by a psychosomatic therapist) and the control group (usual care of the GP). For the randomisation we used a random number table, whereas a central and blinded allocation procedure was applied.For the randomisation we used a random number table, whereas a central and blinded allocation procedure was applied.
Patients in the intervention group were asked to complete a questionnaire at baseline, at the end of the intervention (+/- 3 months)and at 6 and 12 months. Patients in the control group completed a questionnaire at baseline, at 3 (equals end of intervention), 6 and 12 months.
Statistical analysis The number of patients identified and recruited by the GP as well as the number of eligible patients who declined to enter the trial were analysed using descriptive statistics. Furthermore, at each stage of the study, we recorded the number of trial participants who completed the study.
The effects of the intervention on the primary outcome measures (VAS and 4DSQ) and the secondary outcome measures (NHL, SF-36 and MAF) were estimated using analysis of covariance with baseline value as a covariate. Data analysis was be performed according to the intention-to-treat principle. Medical consumption was measured using the Cost Diary for medical consumption. Patients recorded their absenteeism and healthcare consumption, such as consulting a GP, hospital, paramedic facilities and alternative medicine. Medication intake was recorded at the start and the end of the study. We used standardised Dutch prices (guide cost research 2009), whereas medication costs were calculated according to the Dutch Pharmaco Therapeutic Compass. Costs by absenteeism were calculated according to the Friction Cost method.
Difference in cost of medical consumption between the control and intervention group were estimated using analysis of covariance with baseline value as a covariate.
Difference in baseline characteristics were analysed with the student's t-test for continue variables and the chi-squared test or Fisher's exact test for categorical variables. P-values of < 0.05 were considered statistical significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychosomatic therapy | Experimental | Other: Psychosomatic therapy, Other: care as usualPsychosomatic therapy consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. Psychosomatic therapy delivered by a psychosomatic therapist. |
| care as usual | Other | Other: care as usualUsual care of the general practitioner |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patients with medical unexplained symptoms who consulting the general practitioner more than once for one or more of the 12 most common symptoms:
- stomach-/abdominal pain,
- back/neck/shoulder pain,
- pain in arms/legs/joints,
- headache, chest pain,
Key exclusion criteria (5 listed)
- patients wich chronic diseases,
- palliative care,
- severe psychiatric disorders,
- long-lasting injury treatment
- patients who are not able to speak, read and write Dutch
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 |
|---|---|---|
| Psychosomatic therapyPsychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS. | Other | Psychosomatic therapy |
| care as usualusual care of the general practitioner | Other | Psychosomatic therapy, care as usual |
Primary outcome
The number of patients identified and recruited
Time frame: one year
The number of patients identified and recruited by the GP
The time needed to include the eligible patients
Time frame: one year
The time needed to include the eligible patients by the GPs
The number of withdrawals in both groups
Time frame: one year
the number of patients that withdraw from the study in both groups
Perceived symptom severity
Time frame: one year
Perceived symptoms severity by patients
Patients' self-rated symptoms of distress, depression, anxiety and somatization
Time frame: one year
Patients' self-rated symptoms of distress, depression, anxiety ansd somatization measured with the Four Dimensional Symptom Questionnaire (4DSQ)
3 secondary outcomes
Symptoms of hyperventilation
Time frame: at baseline, at 3, 6 and 12 months
Physical and mental status and quality of life
Time frame: at baseline, at 3, 6 and 12 months
Level of functioning
Time frame: at baseline, at 3, 6 and 12 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 4 Sep 2015.
- Derived from this study: PubMed 27075027Wortman MS, Lucassen PL, van Ravesteijn HJ, Bor H, Assendelft PJ, Lucas C, Olde Hartman TC. Brief multimodal psychosomatic therapy in patients with medically unexplained symptoms: feasibility and treatment effects. Fam Pract. 2016 Aug;33(4):346-53. doi: 10.1093/fampra/cmw023. Epub 2016 Apr 13.
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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.
Tim C. olde Hartman, MD Phd principal investigator
Radboud University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosomatic therapy and care as usual in people with Medically Unexplained Symptoms and Psychosomatic Therapy, run by Radboud University Medical Center at 8 sites in Netherlands.
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 12 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Netherlands. 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.
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?
The number of patients identified and recruited (time frame: one year). The study lists 5 primary outcomes in all. 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 NCT01935258, 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 4 Sep 2015.