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

Abstract

IntroductionMajor 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 analysisAdolescents 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 disseminationThe 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 detailsClinicalTrials.gov NCT03957850, registered 21st May 2019; URL: https://clinicaltrials.gov/ct2/show/NCT03957850.

Emotion regulation training for adolescents with major depression: Results from a randomized controlled trial.

“…Considering the absent differential effect of the training on our primary outcome measures, it should be noted that our sample size was derived from the assumption of a large effect on rumination (Greimel, Feldmann, et al, 2020; Siegle et al, 2014), so it may well be possible that the absence of significance is due to our sample size being not sufficiently large to detect smaller effects. Indeed, a study researching add-on ER training in addition to CBT on over 400 participants (Berking et al, 2013) similarly only found a small effect of the training on depressive symptoms.…”

“…This study was preregistered on Clinical Trials (identifier: NCT03957850) and a study protocol was previously published in BMJ Open (Greimel, Feldmann, et al, 2020). All study procedures were approved by the local ethics committee of the Medical Faculty of the Ludwig-Maximilians-University (LMU) Munich and were performed in accordance with the latest version of the Declaration of Helsinki.…”

“…Participant flow, including dropouts and exclusions, is visualized in Figure 1. The final sample size of participants who were analyzed was n = 70 ( n = 36 in the experimental group, n = 34 in the control group), which provided reasonable statistical power to detect the expected effect sizes (for details, see Greimel, Feldmann, et al, 2020).…”

Emotional subtypes in patients with depression: A cluster analysis

“…For instance, maladaptive emotion regulations are important factors for development and maintenance of depression (Sloan et al, 2017). However, adaptive strategies, such as reappraisal and acceptance, are useful to alleviate depressive symptoms (Greimel et al, 2020; Sloan et al, 2017). Our preliminary evidence supports that notion of careful selection of MDD subtypes with problems of emotion regulation for specific treatments in patients with MDD.…”

Emotion Regulation Deficits in Adolescent Girls with Major Depression, Anorexia Nervosa and Comorbid Major Depression and Anorexia Nervosa

“…Cognitive behavior therapy has been recommended by NICE guidelines for the treatment of MD and AN in adolescence [78,79] and is well suited to promote adaptive ER strategies and direct focus away from maladaptive coping points. As an add-on to CBT, ER training has shown beneficial effects in adults with MD [80] and similar approaches for ER training in adolescent MD are being developed [81].…”