Transdiagnostic group cognitive behavioural therapy for emotional disorders in primary care: The results of the PsicAP randomized controlled trial

Background: Emotional disorders are highly prevalent in primary care. We aimed to determine whether a transdiagnostic psychological therapy plus treatment-as-usual (TAU) is more efficacious than TAU alone in primary care adult patients. Methods: A randomized, two-arm, single-blind clinical trial was conducted in 22 primary care centres in Spain. A total of 1061 adult patients with emotional disorders were enrolled. The transdiagnostic protocol (n = 527) consisted of seven 90-min sessions (8-10 patients) delivered over a 12-14-week period. TAU (n = 534) consisted of regular consultations with a general practitioner. Primary outcome measures were self-reported symptoms of anxiety, depression, and somatizations. Secondary outcome measures were functioning and quality of life. Patients were assessed at baseline, post-treatment, and at 3, 6, and 12 months. Intention-to-treat and per-protocol analyses were performed. Results: Post-treatment primary outcomes were significantly better in the transdiagnostic group compared to TAU (anxiety: p 0.80) in favour of the transdiagnostic group after treatment and at the 12-month follow-up. Conclusions: Adding a brief transdiagnostic psychological intervention to TAU may significantly improve outcomes in emotional disorders treated in primary care. Trial Registration isrctn.org identifier: ISRCTN58437086 Copyrigh