Supplementary Material for: Effectiveness of Schema Therapy vs Cognitive Behavioral Therapy vs Supportive Therapy for Depression in an Inpatient and Day Clinic Setting: A Randomized Clinical Trial

Introduction: Schema therapy (ST) reduces depressive symptoms, but clinical trials have not investigated its effectiveness for patients suffering from severe forms of depression and high rates of comorbidities. There is high demand for exploring and improving treatments for this patient group. The objective of the current study is to evaluate whether ST is more effective than individual supportive therapy (IST) and non-inferior compared with cognitive behavioral therapy (CBT) in treating depression.
Methods: For this clinical trial, medicated patients were recruited in inpatient and day clinics setting. Major inclusion criteria were age between 18 and 75 years and primary diagnosis of depression without psychotic symptoms. A total of 292 participants were randomized to ST, CBT or IST and received 7 weeks of psychotherapy (up to 14 individual and 14 group sessions). Primary outcome was change in depression severity after treatment measured by Beck Depression Inventory (BDI-II). Primary test for efficacy was superiority of ST over IST. Secondary test was non-inferiority of ST compared with CBT. Multilevel modelling was conducted. Results at 6-months follow up were explored.
Results: Across treatment, ST was not superior to IST. Secondary outcome analyses and completer analyses showed similar results. However, ST showed clinically relevant non-inferiority compared with CBT.
Conclusion: ST for depression as part of a psychiatric care program showed clinical non-inferiority compared to CBT, without being superior to IST. ST represents a potentially useful addition to the therapeutic repertoire for the treatment of depression, but its efficacy, including long-term efficacy, should be evaluated further.