Cognitive Reappraisal in Adolescents With Major Depression: From Neurobiological Mechanisms to Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Change in perceived stress via the Perceived Stress Scale (PSS-10)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change in perceived stress via the Perceived Stress Scale (PSS-10)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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.)
- 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.)
研究者
Ellen Greimel
Postdoctoral Researcher
Ludwig-Maximilians - University of Munich