Effective group training for patients with unexplained physical symptoms: a randomized controlled trial with a non-randomized one-year follow-up.

Background: Although cognitive-behavioral therapy for Unexplained Physical Symptoms (UPS) is effective in secondary care, studies done in primary care produced implementation problems and conflicting results. We evaluated the effectiveness of a cognitive-behavioral group training tailored to primary care patients and provided by a secondary community mental-health service reaching out into primary care.

Methodology/principal Findings: The effectiveness of this training was explored in a randomized controlled trial. In this trial, 162 patients with UPS classified as undifferentiated somatoform disorder or as chronic pain disorder were randomized either to the training or a waiting list. Both lasted 13 weeks. The preservation of the training's effect was analyzed in non-randomized follow-ups, for which the waiting group started the training after the waiting period. All patients attended the training were followed-up after three months and again after one year. The primary outcomes were the physical and the mental summary scales of the SF-36. Secondary outcomes were the other SF-36-scales and the SCL-90-R. The courses of the training's effects in the randomized controlled trial and the follow-ups were analyzed with linear mixed modeling. In the randomized controlled trial, the training had a significantly positive effect on the quality of life in the physical domain (Cohen's d = 0.38;p = .002), but this overall effect was not found in the mental domain. Regarding the secondary outcomes, the training resulted in reporting an improved physical (Cohen's d = 0.43;p = 0.01), emotional (Cohen's d = 0.44;p = 0.01), and social (Cohen's d = 0.36;p = 0.01) functioning, less pain and better functioning despite pain (Cohen's d = 0.51;p = <0.001), less physical symptoms (Cohen's d = -.23;p = 0.05) and less sleep difficulties (Cohen's d = -0.25;p = 0.04) than time in the waiting group. During the non-randomized follow-ups, there were no relapses.

Conclusions/significance: The cognitive-behavioral group training tailored for UPS in primary care and provided by an outreaching secondary mental-health service appears to be effective and to broaden the accessibility of treatment for UPS.

Trial Registration: TrialRegister.nl NTR1609