Psychosomatic therapy for patients with medically unexplained symptoms

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27191

Enrollment

158

Registered

2018-07-13

Start date

2018-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Medically unexplained symptoms (MUS) Somatisch onvoldoende verklaarde lichamelijke klachten (SOLK)

Interventions

Patients randomized to the intervention group will be invited to attend 6 to12 sessions, depending on the severity of the complaints, of tailor-made psychosomatic therapy, lasting 45 minutes each. The

Eligibility

Inclusion criteria

Inclusion criteria: The target population includes primary care patients aged 18-80 years who frequently, i.e. twice or more in the last 3 months, consult their GP for MUS. Patients should 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.

Design outcomes

Primary

Measure	Time frame
The primary clinical outcome is patients’ level of specific functioning and disability measured with the patient-specific functional scale (PSFS). The primary outcome measure for the economic evaluation is quality of life assessed by the SF-6D, which will be derived from the SF-36. Health care costs, medical consumption and work limitations will be assessed with the Medical Consumption Questionnaire (iMCQ) and work limitations with the Productivity Cost Questionnaire (iPCQ).	—

Measure

Time frame

The primary clinical outcome is patients’ level of specific functioning and disability measured with the patient-specific functional scale (PSFS). The primary outcome measure for the economic evaluation is quality of life assessed by the SF-6D, which will be derived from the SF-36. Health care costs, medical consumption and work limitations will be assessed with the Medical Consumption Questionnaire (iMCQ) and work limitations with the Productivity Cost Questionnaire (iPCQ).

—

Secondary

Measure	Time frame
Perceived symptom severity (NRS); Self-rated symptoms of distress, depression, anxiety and somatization (4DSQ); Physical and mental health status and quality of life (SF-36); Health anxiety, illness behaviour and illness beliefs (resp. IAS and IPQ-K); Patients' perceived recovery and satisfaction with the psychosomatic therapy (GPE); number of GP consults.	—

Contacts

Public ContactMargreet Wortman

m.wortman@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)