Promoting Therapeutic Alliance in Clozapine Users: An Exploratory Randomized Controlled Trial

Objective: To pilot a brief cognitive behavioral therapy-based intervention designed to enhance client empowerment and the therapeutic alliance with the aim of reducing clozapine discontinuation. Design: Randomized controlled trial with two conditions: therapy (Alliance Enhancement Therapy [AET]) and control (psychoeducation alone). Assess ments took place at: baseline, twelve weeks and twenty-four weeks (follow-up). The primary outcomes were levels of empowerment, alliance with the clinical team and clozapine discontinuation. Secondary outcomes included insight and other clinical measures. Methods: Treatment-resistant patients who had a diagnosis of schizophrenia, had been registered for clozapine in the previous month and who consented, were independently randomized to active versus control therapy. Results: Thirty-nine patients entered the study. Both groups improved on the main measures with no differential effects of AET intervention. However, patients who attended for more than five sessions showed a differen tial enhancement of working alliance. Conclusions: Although the active therapy showed no general improvement, it did provide some added value over psychoeducation alone when patients attended several sessions. Effective methods of reducing clozapine discontinuation and engaging patients in psychosocial interventions are needed.