Adverse events during a disorder-specific psychotherapy compared to a nonspecific psychotherapy in patients with chronic depression.

OBJECTIVES: A recent trial comparing Cognitive Behavioral Analysis System of Psychotherapy (CBASP) and supportive psychotherapy in chronic depression found CBASP to be more effective in treating depressive symptoms. We aimed to evaluate adverse events that occurred during this trial. MATERIALS AND METHOD: A randomized trial of chronically depressed outpatients was performed. The treatment included 32 sessions of CBASP or supportive psychotherapy. Therapists asked patients about adverse events and their intensity in each session using a standardized checklist. We analyzed the mean number of (severe) adverse events per patient up to Session 32 with gamma frailty recurrent event models. RESULTS: Two hundred and sixty patients were included in the analyses (66% female, mean age 45 years). Patients in the supportive psychotherapy group reported less severe adverse events in general, and less severe adverse events related to personal life and to occupational life than patients in the CBASP group. Less adverse events related to suicidal thoughts were reported in the CBASP compared with the supportive psychotherapy group. CONCLUSIONS: Differences in the adverse events profile may be explained by the treatment elements. Adverse events related to personal and occupational life for example might be considered a necessary and expected yet temporary adverse treatment outcome of an effective CBASP treatment.