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Cognitive Reappraisal in Adolescents With Major Depression

Not Applicable
Completed
Conditions
Major Depressive Disorder
Interventions
Behavioral: Control Training
Behavioral: Cognitive Reappraisal Training
Registration Number
NCT03957850
Lead Sponsor
Ludwig-Maximilians - University of Munich
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
71
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control Training GroupControl TrainingControl Training Group will perform 4 control sessions without Cognitive Reappraisal Training during which behavioral responses, ERP and eye-tracking data are collected.
Cognitive Reappraisal Training GroupCognitive Reappraisal TrainingCognitive 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.
Primary Outcome Measures
NameTimeMethod
Change in perceived stress via the Perceived Stress Scale (PSS-10)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 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.

Change in negative and positive affect via the Positive and Negative Affect Schedule for Children-Short Form (PANAS-C-SF)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).

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.

Change in rumination as assessed via the German adaptation of the Response Style Questionnaire (RSQ-D)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 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.

Change in depressive Symptoms via the Beck Depression Inventory - Second Edition (BDI-II)Pretraining & after completion of the last of four training session. The training sessions will take place within the time frame of two weeks.

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.

Secondary Outcome Measures
NameTimeMethod
Changes in the downregulation of the LPP (late positive potential) to negative pictures via CRDuring each of the four training sessions, which will take place within the time frame of two weeks.

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.

Changes in the percent gaze fixations in emotional areas of interest within negative picturesDuring each of the four training sessions, which will take place within the time frame of two weeks.

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.

Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scaleDuring each of the four training sessions, which will take place within the time frame of two weeks.

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.

Trial Locations

Locations (1)

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

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Munich, Bavaria, Germany

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