Modular-based psychotherapy (MoBa) versus cognitive–behavioural therapy (CBT) for patients with depression, comorbidities and a history of childhood maltreatment: study protocol for a randomised controlled feasibility trial

INTRODUCTION: In depression treatment, most patients do not reach response or remission with current psychotherapeutic approaches. Major reasons for individual non-response are interindividual heterogeneity of etiological mechanisms and pathological forms, and a high rate of comorbid disorders. Personalised treatments targeting comorbidities as well as underlying transdiagnostic mechanisms and factors like early childhood maltreatment may lead to better outcomes. A modular-based psychotherapy (MoBa) approach provides a treatment model of independent and flexible therapy elements within a systematic treatment algorithm to combine and integrate existing evidence-based approaches. By optimally tailoring module selection and application to the specific needs of each patient, MoBa has great potential to improve the currently unsatisfying results of psychotherapy as a bridge between disorder-specific and personalised approaches. METHODS AND ANALYSIS: In a randomised controlled feasibility trial, N=70 outpatients with episodic or persistent major depression, comorbidity and childhood maltreatment are treated in 20 individual sessions with MoBa or standard cognitive–behavioural therapy for depression. The three modules of MoBa focus on deficits associated with early childhood maltreatment: the systems of negative valence, social processes and arousal. According to a specific questionnaire-based treatment algorithm, elements from cognitive behavioural analysis system of psychotherapy, mentalisation-based psychotherapy and/or mindfulness-based cognitive therapy are integrated for a personalised modular procedure. As a proof of concept, this trial will provide evidence for the feasibility and efficacy (post-treatment and 6-month follow-up) of a modular add-on approach for patients with depression, comorbidities and a history of childhood maltreatment. Crucial feasibility aspects include targeted psychopathological mechanisms, selection (treatment algorithm), sequence and application of modules, as well as training and supervision of the study therapists. ETHICS AND DISSEMINATION: This study obtained approval from the independent Ethics Committees of the University of Freiburg and the University of Heidelberg. All findings will be disseminated broadly via peer-reviewed articles in scientific journals and contributions to national and international conferences. TRIAL REGISTRATION NUMBER: DRKS00022093.