A brief transdiagnostic group (the take control course) compared to individual low-intensity CBT for depression and anxiety: a randomized non-inferiority trial.

ABSTRACT

Few studies have examined brief transdiagnostic groups. The Take Control Course (TCC) was developed for patients with mild to moderate common mental health problems. We examined whether TCC is non-inferior to individual low-intensity cognitive behaviour therapy (CBT) in a single-blind individually randomised parallel non-inferiority trial. The primary outcomes were depression (PHQ9) and anxiety (GAD7) at 6-month follow-up (primary outcome point) and 12-month follow-up. The non-inferiority margin that we set, based on previous trials, corresponds to approximately 3 points on the PHQ9 and approximately 2.5 points on the GAD7. Intention-to-treat (ITT) and per-protocol (PP) analyses of 6-month data of 156 randomised patients indicated that TCC was non-inferior to individual low-intensity CBT on anxiety (ITT Coefficient = 0.24; 95% CI -1.45 to 1.92; d = 0.04; p = .79), and depression (ITT Coefficient = 0.82; 95% CI -1.06 to 2.69; d = 0.14; p = .39) outcomes, and functioning (ITT Coefficient = 0.69; 95% CI -2.56 to 3.94; d = 0.08; p = .68). The findings at 12 months were inconclusive and require further testing. This randomised trial provides preliminary support that TCC is not less effective than short-term individual CBT within Improving Access to Psychological Therapies (IAPT) services.