Abstract
BackgroundMajor depressive disorder represents (MDD) a major cause of disability and disease burden. Beside antidepressant medication, psychotherapy is a key approach of treatment. Schema therapy has been shown to be effective in the treatment of psychiatric disorders, especially personality disorders, in a variety of settings and patient groups. Nevertheless, there is no evidence on its effectiveness for MDD in an inpatient nor day clinic setting and little is known about the factors that drive treatment response in such a target group.MethodsIn the current protocol, we outline OPTIMA (OPtimized Treatment Identification at the MAx Planck Institute): a single-center randomized controlled trial of schema therapy as a treatment approach for MDD in an inpatient and day clinic setting. Over the course of 7 weeks, we compare schema therapy with cognitive behavioral therapy and individual supportive therapy, conducted in individual and group sessions and with no restrictions regarding concurrent antidepressant medication, thus approximating real-life treatment conditions. N = 300 depressed patients are included. All study therapists undergo a specific training and supervision and therapy adherence is assessed. Primary outcome is depressive symptom severity as self-assessment (Beck Depression Inventory-II) and secondary outcomes are clinical ratings of MDD (Montgomery-Asberg Depression Rating Scale), recovery rates after 7 weeks according to the Munich-Composite International Diagnostic Interview, general psychopathology (Brief Symptom Inventory), global functioning (World Health Organization Disability Assessment Schedule), and clinical parameters such as dropout rates. Further parameters on a behavioral, cognitive, psychophysiological, and biological level are measured before, during and after treatment and in 2 follow-up assessments after 6 and 24 months after end of treatment.DiscussionTo our knowledge, the OPTIMA-Trial is the first to investigate the effectiveness of schema therapy as a treatment approach of MDD, to investigate mechanisms of change, and explore predictors of treatment response in an inpatient and day clinic setting by using such a wide range of parameters. Insights from OPTIMA will allow more integrative approaches of psychotherapy of MDD. Especially, the identification of intervention-specific markers of treatment response can improve evidence-based clinical decision for individualizing treatment.Trial registrationIdentifier on clinicaltrials.gov: NCT03287362; September, 12, 2017
Highlights
Major depressive disorder represents (MDD) a major cause of disability and disease burden
To our knowledge, the OPTIMA-Trial is the first to investigate the effectiveness of schema therapy as a treatment approach of MDD, to investigate mechanisms of change, and explore predictors of treatment response in an inpatient and day clinic setting by using such a wide range of parameters
Taken together, the OPTIMA-Trial addresses three major objectives: First and main aim is to investigate the immediate and long-term effectiveness of schema therapy (ST) compared to individual supportive therapy (IST) and cognitive behavior therapy (CBT) for moderate to severe MDD in an inpatient and day clinic setting using among others depression self-reports, clinical assessments, and recovery rates
Summary
Major depressive disorder represents (MDD) a major cause of disability and disease burden. Alongside the development of innovative pharmacological approaches such as antiinflammatory drugs [11, 12], the field of psychotherapy has evolved considerably and introduced new forms of treatment for depression such as mindfulness-based cognitive therapy [13], the cognitive behavioral analysis system of psychotherapy [14] or schema therapy (ST) [15]. The latter has become increasingly popular within the last two decades and is the focus of the current study
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