Cognitive Reappraisal in Adolescents With Major Depression (KONNI)

Cognitive Reappraisal in Adolescents With Major Depression: From Neurobiological Mechanisms to Intervention

Major depression (MD) is common during adolescence and associated with significant morbidity and mortality. One important factor for the development and maintenance of adolescent MD are disturbances in emotion regulation, including deficits in cognitive reappraisal (CR). CR is a particularly effective emotion regulation strategy that aims at reinterpreting emotional events to modify affective responses. Adolescents with MD apply this strategy less often than their healthy peers and show disturbances in brain activation patterns underlying CR.

In this study, MD adolescents will be randomly assigned to a group that receives a task-based training in CR or to a control training group. It will be examined whether the task-based CR training is superior to the control training with regard to improvements in negative affect, perceived stress in daily life and depressive symptoms. Moreover, during the four training sessions, the event-related potential "Late Positive Potential" (LPP) will be recorded to assess neurophysiological indices of CR processes and gaze fixations on emotional areas within negative pictures and affective responses to pictures will be collected to identify mechanisms underlying training effects.This study will provide first evidence for the efficacy of a short-time training that has previously shown to be effective in healthy individuals. Moreover, the study will identify neurobiological mechanisms that predict training effects. The results of this investigation will lay the ground for a clinical trial to investigate whether a CR training added to an established intervention improves treatment effects for adolescent MD.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Cognitive Reappraisal Training; Behavioral: Control Training

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Female and male participants
• age range: 12-18 years
• current diagnosis of MD (ICD-10 diagnoses F32.0; F32.1; F32.2, F33.0, F33.1, F.33.2)
• intelligence quotient (IQ) of ≥ 80

Exclusion Criteria:

• neurological disorders
• schizophrenic disorder
• pervasive developmental disorder
• bipolar disorder
• borderline personality disorder
• substance dependence disorder
• gender dysphoria.

Participants comorbid with psychiatric comorbidities other than those listed above are included if MD is the primary diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cognitive Reappraisal Training Group; Cognitive Reappraisal Training group will perform 4 training sessions in Cognitive Reappraisal during which, behavioral responses, event-related potentials (ERPs) and eye-tracking data are collected.	Behavioral: Cognitive Reappraisal Training; The training procedure is adapted from a study by Denny & Ochsner (2014). Before the task, participants are instructed that they will be presented pictures and that these pictures will be preceded by a condition specific cue signaling the appropriate strategy during picture viewing. Participants are instructed to indicate their affective response to the image on a rating scale. The task involves 4 conditions: 1) Negative-decrease: participants are asked to view negative pictures and to decrease their affective response by reappraising the negative event. 2) Negative-attend/ 3) Neutral-attend/ 4) Positive-attend: participants are asked to view pictures and to respond naturally to them without trying to alter their affective response. The training task will be repeated over 4 training sessions.
ACTIVE_COMPARATOR: Control Training Group; Control Training Group will perform 4 control sessions without Cognitive Reappraisal Training during which behavioral responses, ERP and eye-tracking data are collected.	Behavioral: Control Training; The task in the control group is implemented to account for unspecific effects and is as similar as possible to the CR task except that it involves no negative-decrease (i.e., no reappraisal) condition. Instead, the control task only involves the three attend conditions (negative- attend, neutral-attend, positive-attend).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)	A change in negative affect will be assessed based on the Negative Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more negative affect. A change in positive affect will be assessed based on the Positive Affect scale of the PANAS-C-SF. This scale ranges from one to five, with higher scores indicating more positive affect.	Over the course of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (2 weeks after the end of the entire training).
Change in perceived stress via the Perceived Stress Scale (PSS-10)	Change in perceived stress will be assessed based on the German adaption of the PSS-10. This scale ranges from 1-5, with higher scores indicating more perceived stress.	During each of the four training sessions, which will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in rumination as assessed via the German adaptation of the Response Style Questionnaire (RSQ-D)	Change in rumination will be assessed based on two separate rumination subscales of the RSQ-D. The self-focused rumination scale ranges from 7-28, with higher scores indicating higher self-focused rumination. The symptom-focused rumination scale ranges from 8-31, with higher scores indicating higher symptom-focused rumination.	Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks. This outcome measure will be reassessed at follow-up (two weeks after the end of the training sessions).
Change in depressive Symptoms via the Beck Depression Inventory - Second Edition (BDI-II)	Change in depressive symptoms will be assessed based on the BDI-II. This scale ranges from 0-63, with higher scores indicated more depressive symptoms.	Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scale	Affective behavioral responses to negative pictures will be continuously assessed during each of the four training sessions. This assessment is based on the self-assessment manikin scale for valence (Bradley & Lang, 1994), which is a 9-point rating scale with higher scores indicating higher positive affect. To obtain a behavioral index of downregulated affect in the CR training group, averaged behavioral affective responses during an attend condition will be subtracted from averaged behavioral affective responses during an active regulate condition.	During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the downregulation of the LPP (late positive potential) to negative pictures via CR	The LPP elicited to negative pictures will be continuously assessed during each of the four training sessions. To calculate the downregulation of the LPP via CR in the CR training group, the averaged LPP during an attend condition will be subtracted from the averaged LPP during an active regulate condition.	During each of the four training sessions, which will take place within the time frame of two weeks.
Changes in the percent gaze fixations in emotional areas of interest within negative pictures	Changes in the percent duration of gaze fixations within a-priori defined emotional interest areas within negative pictures will be exploratively assessed over the course of the four training sessions.	During each of the four training sessions, which will take place within the time frame of two weeks.

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Collaborators: German Research Foundation; RWTH Aachen University; University of Amsterdam
• Investigators: Principal Investigator: Ellen Greimel, PhD, Department of Child&Adolescent Psychiatry, Psychosomatics&Psychoth.,LMU Munich

Publications and helpful links

General Publications

• Denny BT, Ochsner KN. Behavioral effects of longitudinal training in cognitive reappraisal. Emotion. 2014 Apr;14(2):425-33. doi: 10.1037/a0035276. Epub 2013 Dec 23.
• Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
• Greimel E, Feldmann L, Piechaczek C, Oort F, Bartling J, Schulte-Ruther M, Schulte-Korne G. Study protocol for a randomised-controlled study on emotion regulation training for adolescents with major depression: the KONNI study. BMJ Open. 2020 Sep 10;10(9):e036093. doi: 10.1136/bmjopen-2019-036093.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2019
• Primary Completion (ACTUAL): November 22, 2021
• Study Completion (ACTUAL): November 22, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (ACTUAL): May 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Adolescence; Major Depression; Cognitive Reappraisal; Eye-tracking; LPP; Event-related Potentials; Emotion Regulation Training
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 399482529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data in our study contains sensitive patient information, such as sociodemographic information and comorbidities. Since patients could possibly be identified by making our raw data publicly available, ethical principles of protecting patient confidentiality would be breached. Aggregated group data can be made available upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No