Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care.

OBJECTIVE: To evaluate the effectiveness of psychosomatic therapy versus care as usual in primary care for patients with persistent somatic symptoms (PSS).

METHODS: We conducted a pragmatic, two-armed, randomised controlled trial among primary care patients with PSS in the Netherlands that included 39 general practices and 34 psychosomatic therapists. The intervention, psychosomatic therapy, consisted of 6-12 sessions delivered by specialised exercise- and physiotherapists.

PRIMARY OUTCOME MEASURE: patient's level of functioning.

SECONDARY OUTCOMES: severity of physical and psychosocial symptoms, health-related quality of life, health-related anxiety, illness behaviour and number of GP contacts.

RESULTS: Compared to usual care (n = 85), the intervention group (n = 84) showed no improvement in patient's level of functioning (mean difference - 0.50 [95% CI -1.10 to 0.10]; p = .10), and improvement in health-related anxiety (mean difference - 1.93 [95% CI -3.81 to -0.04]; p = .045), over 12 months. At 5-month follow-up, we found improvement in physical functioning, somatisation, and health-related anxiety. The 12-month follow-up revealed no therapy effects. Subgroup analyses showed an overall effect in patient's level of functioning for the group with moderate PSS (mean difference - 0.91 [95% CI -1.78 to -0.03]; p = .042). In the year after the end of therapy, the number of GP contacts did not differ significantly between the two groups.

CONCLUSION: We only found effects on some secondary outcome measures, and on our primary outcome measure especially in patients with moderate PSS, the psychosomatic therapy appears promising for further study.

TRIAL REGISTRATION: the trial is registered in the Netherlands Trial Registry, https://trialsearch.who.int/Trial2.aspx?TrialID=NTR7356 under ID NTR7356.