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Cost-effectiveness of psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms

Cost-effectiveness of psychosomatic therapy for patients frequently attending primary care with medically unexplained symptoms - CORPUS trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49180
Enrollment
158
Registered
2018-06-20
Start date
2019-01-03
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

onvoldoende verklaarde lichamelijke klachten Medically Unexplained Symptoms (MUS)

Interventions

Intervention: Patients randomised to the intervention group will be invited to attend 6 to 12 sessions of tailor-made psychosomatic therapy lasting 45 minutes each. These sessions are additional to

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The target population included primary care patients aged 18 and over who frequently, twice or more in the recent period, consult their GP for MUS. Patients have a PHQ-15 score of >= 5.

Exclusion criteria

Exclusion criteria: Exclusion criteria are receiving palliative care, having a severe psychiatric disorder (i.e. psychosis-related disorders, dementia and bipolar disorder), mental retardation, visual impairment, illiteracy, insufficient understanding of the Dutch language and age above 80 years.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure: In order to estimate likely treatment effects we will measure patients* level of specific functioning and disability measured with the patient-specific functional scale (PSFS). The PSFS is a self-reported thoroughly validated measurement instrument for up to three individual activity limitations rated on a 11-point numeric rating scale ranging 0-10 (0 represents not a problem at all and 10 impossible).

Secondary

MeasureTime frame
Secondary outcome measures: - Perceived symptom severity measured on a Visual Analogue Scale (VAS) (range 0-10; 10 represents most severe symptoms). - Patients* self-rated symptoms of distress, depression, anxiety and somatization measured on Four Dimensional Symptom Questionnaire (4DSQ). 4DSQ subscales distress and somatisation scores range from 0 to 32 (low: 0-10; moderate: 11-20; high: 21-32), subscale anxiety scores range from 0 to 24 (low: 0-7; moderate: 8-12; high: 13-24) and subscale depression scores range from 0 to 12 (low: 0-2; moderate: 3-5; high: 6-12), so higher scores represent worse health. - Physical and mental health status and quality of life are measured with the Short Form Health Survey-36 items (SF-36). SF-36 scores range from 0 to 100, where higher scores correspond to better health. From the SF-36 scores the mental component summary (MCS) and the physical component summary (PCS) will be calculated. - Health anxiety and illness behaviour are measured with the Illness Attitude Scale (IAS) on a five point Likert-scale (ranging from 0 (never) to 4 (most of the time)). -Illness beliefs are measured with the IPQ-K on a 11-point NRS, ranging 0 (not at all) to 10 (very much) - Patient perceived recovery and satisfaction with the psychosomatic therapy are measured with the Global Perceived Effect scale (GPE) on a seven point Likert scale (from completely recovered to worse than ever). - Health care costs, medical consumption and work limitations will be measured by the Medical Consumption Questionnaire (iMCQ) and work limitations by the Productivity Cost Questionnaire (iPCQ). Baseline characteristics age, gender, marital status, social economic status (employment and level of education), source of income, working hours, intensity and duration of MUS, expectations about the prognosis of complaints and expectations about the effect of the treatment will be included in the first questionnaire. The GP will be asked for the

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)