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. Perso...

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Main Authors: Elisabeth Schramm, Martin Hautzinger, Carolin Jenkner, Moritz Elsaesser, Sabine Herpertz, Hannah Piosczyk
Format: Article
Language:English
Published: BMJ Publishing Group 2022-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/7/e057672.full
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author Elisabeth Schramm
Martin Hautzinger
Carolin Jenkner
Moritz Elsaesser
Sabine Herpertz
Hannah Piosczyk
author_facet Elisabeth Schramm
Martin Hautzinger
Carolin Jenkner
Moritz Elsaesser
Sabine Herpertz
Hannah Piosczyk
author_sort Elisabeth Schramm
collection DOAJ
description 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.
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spelling doaj-art-b4145020037e490bb4a512008e91a58c2025-01-31T17:15:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-057672Modular-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 trialElisabeth Schramm0Martin Hautzinger1Carolin Jenkner2Moritz Elsaesser3Sabine Herpertz4Hannah Piosczyk5Department of Psychiatry and Psychotherapy, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, GermanyDepartment of Psychology, Clinical Psychology, and Psychotherapy, Eberhard Karls University of Tübingen, Tübingen, GermanyClinical Trials Unit, Universitatsklinikum Freiburg, Freiburg, GermanyDepartment of Psychiatry and Psychotherapy, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, GermanyDepartment of General Psychiatry, Heidelberg University, Heidelberg, GermanyDepartment of Psychiatry and Psychotherapy, Medical Center and Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, GermanyIntroduction 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.https://bmjopen.bmj.com/content/12/7/e057672.full
spellingShingle Elisabeth Schramm
Martin Hautzinger
Carolin Jenkner
Moritz Elsaesser
Sabine Herpertz
Hannah Piosczyk
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/12/7/e057672.full
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