Background: We hypothesized that somatizing patients managed by primary care physicians (PCP) would improve with a relationship-based intervention.
Methods: We randomized 30 adults with medically unexplained symptoms to treatment or usual care. Four PCPs were trained to intervene with cognitive-behavioral, pharmacological, and patient-centered management and deployed the intervention with seven scheduled visits over 12 months. Outcomes obtained at baseline and 12 months were: Mental component summary (MCS), the primary endpoint, and measures of physical and psychological symptoms and of satisfaction with the PCP.
Results: Patients averaged 52.5 years; 83.3% were female; 79.6% were black. Using a difference of differences approach, we found that the intervention produced a large effect size (ES) (0.82; CI: 0.08 to 1.57) for the MCS in the predicted direction, similar to the ES for physical (-0.80; CI: -1.55 to -0.04) and psychological (-1.06; CI: -1.83 to -0.28) improvement and for increased satisfaction with the PCP (0.94; CI: 0.15 to 1.74). Using ANCOVA in a sensitivity analysis, we found that the ES fell slightly (0.59), while other measures were unchanged.
Conclusions: Moderate-large effect sizes support the hypothesis that PCPs can effectively treat somatization. This points to the importance of performing a full RCT.