Psychosomatic Therapy, Feasibility and Cost Analysis

Medically Unexplained Symptoms Clinical Trial

— PsySom  

Official title:

Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935258
• Other study ID #: 2012/365
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: September 3, 2015
• Start date: April 2013
• Est. completion date: February 2015

Study information

• Verified date: September 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Medically Unexplained Symptoms
• Psychosomatic Therapy

Intervention

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.
• care as usual
usual care of the general practitioner

Locations

Country	Name	City	State
Netherlands	General Practitioner, Douwes Dekker	Albergen	Overijssel
Netherlands	General Practitioner, Hesselink	Borne	Overijssel
Netherlands	M. Oijevaar	Borne
Netherlands	General Practitioner,Tuijnenburg	Enschede	Overijssel
Netherlands	General Practitioner, Kleissen	Haaksbergen	Overijssel
Netherlands	General Practitioner, van der Waart	Hengelo	Overijssel
Netherlands	D.J. Jansen	Julianadorp
Netherlands	General Practitioner, Van Rijn	Vriezenveen	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical consumption	Medical consumption will be measured by the Cost Diary for medical consumption.	at baseline, at 3, 6 and 12 months	No
Other	Baseline characteristics of the participants	Patient satisfaction with the received therapy is rated on a 5-point Likert-scale	at baseline, at 3, 6 and 12 months	No
Primary	The number of patients identified and recruited	The number of patients identified and recruited by the GP	one year	No
Primary	The time needed to include the eligible patients	The time needed to include the eligible patients by the GPs	one year	No
Primary	The number of withdrawals in both groups	the number of patients that withdraw from the study in both groups	one year	No
Primary	Perceived symptom severity	Perceived symptoms severity by patients	one year	No
Primary	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)	one year	No
Secondary	Symptoms of hyperventilation	symptoms of hyperventilation measured by the NHL (Nijmegen Hyperventilation List) according to patients	at baseline, at 3, 6 and 12 months	No
Secondary	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	at baseline, at 3, 6 and 12 months	No
Secondary	Level of functioning	Level of functioning according to patients are measured by the MAF (measure of general functioning)	at baseline, at 3, 6 and 12 months	No