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 < 0.001; Morris's d = −0.65; depression: p < 0.001; d = −0.58, and somatic symptoms: p < 0.001; d = −0.40). These effects were sustained at the 12-month follow-up (anxiety: p < 0.001; d = −0.44; depression: p < 0.001; d = −0.36 and somatic symptoms: p < 0.001; d = −0.32). The transdiagnostic group also had significantly better outcomes on functioning (d = 0.16–0.33) and quality of life domains (d = 0.24–0.42), with sustained improvement at the 12-month follow-up in functioning (d = 0.25–0.39) and quality of life (d = 0.58–0.72). Reliable recovery rates showed large between-group effect sizes (d > 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