Cognitive Reappraisal in Adolescents With Major Depression

NCT03957850 | Completed

• 1 other identifier: 399482529
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Emotion Regulation Training; LPP; Adolescence; Major Depression; Eye-tracking; Cognitive Reappraisal; Event-related Potentials

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Changes in the downregulation of affective behavioral responses to negative pictures via CR based on the self-assessment manikin scale

  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

  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

  During each of the four training sessions, which will take place within the time frame of two weeks.

Study Arms (2)

Cognitive Reappraisal Training Group

EXPERIMENTAL

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

Control Training Group

ACTIVE COMPARATOR

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

Interventions

Cognitive Reappraisal Training BEHAVIORAL

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.

Cognitive Reappraisal Training Group

Control Training BEHAVIORAL

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).

Control Training Group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead
• German Research Foundation: collaborator
• RWTH Aachen University: collaborator
• University of Amsterdam: collaborator

Study Sites (1)

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

Munich, Bavaria, 80336, Germany

Location

Related Publications (4)

• 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.

  PMID: 24364856 BACKGROUND

• 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.

  PMID: 7962581 BACKGROUND

• Zsigo C, Feldmann L, Oort F, Piechaczek C, Bartling J, Schulte-Ruther M, Wachinger C, Schulte-Korne G, Greimel E. Emotion regulation training for adolescents with major depression: Results from a randomized controlled trial. Emotion. 2024 Jun;24(4):975-991. doi: 10.1037/emo0001328. Epub 2023 Dec 7.

  PMID: 38060020 DERIVED

• 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.

  PMID: 32912977 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ellen Greimel, PhD

  Department of Child&Adolescent Psychiatry, Psychosomatics&Psychoth.,LMU Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant-blind clinical trial: the participants are blinded regarding the allocation to the respective training group (CR training or control training). Upon completion of the training (including questionnaire assessment), participants are unblinded regarding the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 21, 2019
• Study Start: May 27, 2019
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: August 23, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)