Clinical trial NCT01935258: Psychosomatic Therapy, Feasibility and Cost Analysis
Official title: Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medically Unexplained Symptoms
Psychosomatic Therapy
Keywords: Medically unexplained symptoms
Somatization
Psychosomatic therapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-09-05
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: The number of patients identified and recruited
timeFrame: one year
measure: The time needed to include the eligible patients
timeFrame: one year
measure: The number of withdrawals in both groups
timeFrame: one year
measure: Perceived symptom severity
timeFrame: one year
measure: Patients' self-rated symptoms of distress, depression, anxiety and somatization
timeFrame: one year
Secondary outcomes:
measure: Symptoms of hyperventilation
timeFrame: at baseline, at 3, 6 and 12 months
measure: Physical and mental status and quality of life
timeFrame: at baseline, at 3, 6 and 12 months
measure: Level of functioning
timeFrame: at baseline, at 3, 6 and 12 months
Other outcomes:
measure: Medical consumption
timeFrame: at baseline, at 3, 6 and 12 months
measure: Baseline characteristics of the participants
timeFrame: at baseline, at 3, 6 and 12 months
Locations:
city: Albergen
country: Netherlands
facility: General Practitioner, Douwes Dekker
state: Overijssel
city: Borne
country: Netherlands
facility: General Practitioner, Hesselink
state: Overijssel
city: Enschede
country: Netherlands
facility: General Practitioner,Tuijnenburg
state: Overijssel
city: Haaksbergen
country: Netherlands
facility: General Practitioner, Kleissen
state: Overijssel
city: Hengelo
country: Netherlands
facility: General Practitioner, van der Waart
state: Overijssel
city: Vriezenveen
country: Netherlands
facility: General Practitioner, Van Rijn
state: Overijssel
city: Borne
country: Netherlands
facility: M. Oijevaar
city: Julianadorp
country: Netherlands
facility: D.J. Jansen
Study officials:
affiliation: Radboud University Medical Center
name: Tim C. olde Hartman, MD Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.