Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT01935258
Status:
COMPLETED
Last Update Posted:
2015-09-04
First Post:
2013-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psychosomatic Therapy, Feasibility and Cost Analysis
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Psychosomatic Therapy, Feasibility and Cost Analysis, a Pilot Randomised Trial
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PsySom
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: