Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study

BMJ Open, vol. 10, pp. e036093

Abstract

INTRODUCTION: Major depression (MD) often has its onset during adolescence and is associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation and the underlying neural processes. Cognitive reappraisal (CR) is a particular adaptive emotion regulation strategy. Previously, it has been shown in healthy adults that a task-based training in CR is efficient to reduce negative affect, and that these effects translate into everyday life.This randomised controlled trial examines for the first time whether a task-based training in CR proves effective in MD adolescents. Specifically, we will investigate whether the CR training improves the ability to downregulate negative affect in MD individuals as assessed by behavioural and neurobiological indices, and whether training effects generalise outside the laboratory. METHODS AND ANALYSIS: Adolescents with MD will be randomly allocated to a group that either receives a task-based training in CR or a control training. Both involve four training sessions over a time period of 2 weeks. In the CR training, participants will be instructed to downregulate negative affective responses to negative pictures via CR, while the control training involves picture viewing. During the training sessions, the Late Positive Potential, gaze fixations on negative picture aspects and affective responses to pictures will be collected. Before and after the training programmes, and at a 2-week follow-up, overall negative and positive affect, rumination and perceived stress will be assessed as primary outcomes. Analyses of variance will be conducted to test the effectiveness of the CR training with regard to both primary outcomes and task-based behavioural and neurobiological parameters. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee of the Medical Faculty of the LMU Munich, Germany. The results will be published in peer-reviewed journals and disseminated through conferences, social media and public events. TRIAL REGISTRATION DETAILS: May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850.

Authors 7

1. Ellen Greimel corresponding

   LMU Klinikum · Ludwig-Maximilians-Universität München

   Affiliation as printed

   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany

2. Lisa Feldmann

   LMU Klinikum · Ludwig-Maximilians-Universität München

   Affiliation as printed

   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany

3. Charlotte Piechaczek

   LMU Klinikum · Ludwig-Maximilians-Universität München

   Affiliation as printed

   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany

4. Frans Jeroen Oort

   University of Amsterdam

   Affiliation as printed

   Research Institute of Child Development and Education, University of Amsterdam, Amsterdam, Netherlands

5. Jürgen Bartling

   LMU Klinikum · Ludwig-Maximilians-Universität München

   Affiliation as printed

   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany

6. Martin Schulte‐Rüther Aachen Translational Brain Medicine in Psychiatry and Neurology Department of Child and Adolescent Psychiatry

   Universitätsmedizin Göttingen · Jülich Aachen Research Alliance · University of Göttingen · RWTH Aachen University

   Affiliation as printed

   Department of Child and Adolescent Psychiatry and Psychotherapy, University Medical Center Göttingen, Göttingen, Germany

   JARA-Brain, Aachen, Germany

   Translational Brain Medicine in Psychiatry and Neurology, Department of Child and Adolescent Psychiatry, Psychosomatics, and Psychotherapy, RWTH Aachen University, Aachen, Germany

7. Gerd Schulte‐Körne

   LMU Klinikum · Ludwig-Maximilians-Universität München

   Affiliation as printed

   Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Hospital of the Ludwig-Maximilians-University (LMU) Munich, Munich, Germany