Clinical trial NCT03957850: Cognitive Reappraisal in Adolescents With Major Depression
Official title: Cognitive Reappraisal in Adolescents With Major Depression: From Neurobiological Mechanisms to Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Emotion Regulation Training
LPP
Adolescence
Major Depression
Eye-tracking
Cognitive Reappraisal
Event-related Potentials
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: RWTH Aachen University
name: University of Amsterdam
First posted: 2019-05-21
Enrollment: 71
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a short-term randomized controlled, participant-blind clinical trial including two groups of adolescents with MD. MD participants will be randomly assigned to a group that receives task-based training in CR or to a control training. Randomisation will be performed by a statistician, stratifying for age (14 years and younger and 15 years and older) and sex.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)
timeFrame: 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).
measure: Change in perceived stress via the Perceived Stress Scale (PSS-10)
timeFrame: 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).
measure: Change in rumination as assessed via the German adaptation of the Response Style Questionnaire (RSQ-D)
timeFrame: 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).
measure: Change in depressive Symptoms via the Beck Depression Inventory - Second Edition (BDI-II)
timeFrame: Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks.
Secondary outcomes:
measure: Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scale
timeFrame: During each of the four training sessions, which will take place within the time frame of two weeks.
measure: Changes in the downregulation of the LPP (late positive potential) to negative pictures via CR
timeFrame: During each of the four training sessions, which will take place within the time frame of two weeks.
measure: Changes in the percent gaze fixations in emotional areas of interest within negative pictures
timeFrame: During each of the four training sessions, which will take place within the time frame of two weeks.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Munich, Munich, Germany
state: Bavaria
Study officials:
affiliation: Department of Child&Adolescent Psychiatry, Psychosomatics&Psychoth.,LMU Munich
name: Ellen Greimel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.