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Psychosomatic Therapy, Feasibility and Cost Analysis (PsySom)

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ClinicalTrials.gov Identifier: NCT01935258
Recruitment Status : Completed
First Posted : September 5, 2013
Last Update Posted : September 4, 2015
Sponsor:
Information provided by (Responsible Party):
Tim olde Hartman, Radboud University

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Medically Unexplained Symptoms Psychosomatic Therapy Other: Psychosomatic therapy Other: care as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial
Study Start Date : April 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
Experimental: Psychosomatic therapy
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.
Other: Psychosomatic therapy
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.

Other: care as usual
usual care of the general practitioner

care as usual
Usual care of the general practitioner
Other: care as usual
usual care of the general practitioner




Primary Outcome Measures :
  1. The number of patients identified and recruited [ Time Frame: one year ]
    The number of patients identified and recruited by the GP

  2. The time needed to include the eligible patients [ Time Frame: one year ]
    The time needed to include the eligible patients by the GPs

  3. The number of withdrawals in both groups [ Time Frame: one year ]
    the number of patients that withdraw from the study in both groups

  4. Perceived symptom severity [ Time Frame: one year ]
    Perceived symptoms severity by patients

  5. 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)


Secondary Outcome Measures :
  1. Symptoms of hyperventilation [ Time Frame: at baseline, at 3, 6 and 12 months ]
    symptoms of hyperventilation measured by the NHL (Nijmegen Hyperventilation List) according to patients

  2. Physical and mental status and quality of life [ Time Frame: at baseline, at 3, 6 and 12 months ]
    Physical and mental health status and quality of life according to patients are measured by the SF-36

  3. Level of functioning [ Time Frame: at baseline, at 3, 6 and 12 months ]
    Level of functioning according to patients are measured by the MAF (measure of general functioning)


Other Outcome Measures:
  1. Medical consumption [ Time Frame: at baseline, at 3, 6 and 12 months ]
    Medical consumption will be measured by the Cost Diary for medical consumption.

  2. Baseline characteristics of the participants [ Time Frame: at baseline, at 3, 6 and 12 months ]
    Patient satisfaction with the received therapy is rated on a 5-point Likert-scale



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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,
  • fainting spells,
  • palpitations of the heart,
  • shortness of breath,
  • nausea/indigestion,
  • feeling tired,
  • sleeping disorder and psychosocial distress

Exclusion Criteria:

  • patients wich chronic diseases,
  • palliative care,
  • severe psychiatric disorders,
  • long-lasting injury treatment
  • patients who are not able to speak, read and write Dutch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01935258


Locations
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Netherlands
General Practitioner, Douwes Dekker
Albergen, Overijssel, Netherlands, 7665 AP
General Practitioner, Hesselink
Borne, Overijssel, Netherlands, Borne
General Practitioner,Tuijnenburg
Enschede, Overijssel, Netherlands, 7543 EH
General Practitioner, Kleissen
Haaksbergen, Overijssel, Netherlands, 7482 AR
General Practitioner, van der Waart
Hengelo, Overijssel, Netherlands, 7559 NM
General Practitioner, Van Rijn
Vriezenveen, Overijssel, Netherlands, 7672 GD
M. Oijevaar
Borne, Netherlands, 7622DE
D.J. Jansen
Julianadorp, Netherlands, 1787AE
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Tim C. olde Hartman, MD Phd Radboud University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tim olde Hartman, Dr T.C. olde Hartman, Radboud University
ClinicalTrials.gov Identifier: NCT01935258    
Other Study ID Numbers: 2012/365
First Posted: September 5, 2013    Key Record Dates
Last Update Posted: September 4, 2015
Last Verified: September 2015
Keywords provided by Tim olde Hartman, Radboud University:
Medically unexplained symptoms
Somatization
Psychosomatic therapy
Additional relevant MeSH terms:
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Medically Unexplained Symptoms