Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk: A 5-Year Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Onset of a major depressive episode
研究概览
简要总结
The goal of this clinical trial is to learn if intervention of positive emotion working memory (PEWM), or negative emotion working memory (NEWM), or positive attention bias training (PABT) can prevent major depressive disorder (MDD) for the long-term effects of intervention in youth with depressive symptoms or with remitted MDD. The main questions it aims to answer are:
- Does intervention PEWM, NEWM or PABT lower the MDD onset in youth with depressive symptoms or with remitted MDD?
- How long does the intervention PEWM, NEWM or PABT can lower the MDD onset when taken an initial training added one booster training?
- Which cognitive factors can predict MDD onset?
Researchers will compare PEWM, NEWM, PABT to a placebo (a training that contains no active component) to see if the interventions work to prevent MDD.
Participants will:
- Take a PEWM, or a NEWM, or a PABT or a placebo nearly every day for 2 weeks with 10 sessions at initial.
- Take a PEWM, or a NEWM, or a PABT or a placebo the day after tomorrow for 2 weeks with 8 sessions at 6 months follow-up.
- Be interviewed by clinicians with standardized diagnostic schedules for affective disorders and schizophrenia for 5 years
- Answer survey questions about depression-related symptoms for 5 years.
详细描述
- PEWM: It is a computerized n-back task. Stimuli are positive words superimposed on happy facial pictures. Participants judge if the word is the same as the one presented n item(s) ago on the n-back level. If the words are the same, the participants make a key-press. The participants completed 10 sessions with (20 + n ) trials × 15 block each in two weeks at initial and 8 booster sessions at 6 months follow-up. Thus, the participants expose in a positive context, and learn to store and retrieve positive meaning in short-term memory during training.
- NEWM: It is a dual n-back task with visual and auditory channals. The visual stimuli are sad facial pictures presented in one of a 4 × 4 grid. Auditory stimuli are audio record of sad words . Participants judge if the position of the facial picture presented in the grid is the same position as that of the nth previous picture on the n-back level. Meanwhile, they judge if the audio two-charater sad word heard through the earphones is the same meaning as the nth word before. If any of the same, they make separated key-press. The participants take 10 sessions with (20 +n ) trials × 16 block each for two weeks at initial and 8 booster sessions for two weeks at 6 months follow-up. Thus participants learn to focus on the judging task while inhibit the negative information interference.
- Positive Attention Bias Modification (PABM): It is a variant of the dot-probe task. A pair of positive and neutral-concret words presents updown. After the word-pair disappears, a single or double-dot is present, and 90% of the probe dots fall on the position of positive words. The participants judge the number of the dot and press the left or right key of the mouse correspondingly. The participants take 10 sessions (216 trials each) for two weeks at initial and 8 booster sessions for two weeks at 6 months follow-up. They learn to direct attention towards positive words unconsiously.
- Placebo (i.e., neutral attention bias training, NABT): The stimuli are the same as those in the PABT, except 90% of the probe dots falling on the position of concrete neutral words. The participants take 10 sessions (216 trials each) for two weeks at initial and 8 booster sessions for two weeks at 6 months follow-up. they learn to direct attention towards concrete neutral words.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scores of the Beck Depression Inventory-II version (BDI-II) of a participant are equal to or more than 14.
排除标准
- •A participant with
- •A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
- •Any concurrent psychotherapy;
- •Any concurrent psychotropic medication.
研究组 & 干预措施
positive emotion working memory (PEWM )training
The PEWM task is a computerized n-back task. The stimulus presents 2000ms. The longer stimulus duration compared to a standard n-back task is intended to allow participants to more elaboratedly process positive emotion. During the PEWM, each session has 25-35 minutes.
干预措施: positive emotion working memory(PEWM) training (Behavioral)
negative emotion working memory (NEWM) training
The NEWM task was a computerized dual n-back task. The visual stimulus presents 500 milliseconds (ms), followed by a blank screen for 2500 ms. The auditory stimulus presents 500-950 ms at the same time. Participants monitor both modalities. Each session takes 25-35 minutes. The first three sessions started with 1 n-level. From the fourth session , it starts from 2 n-level. The tasks are adjusted difficulty on the participant's performance. When accuracy rates equal to or larger than 90% for both the auditory and visual response, participants give an option to advance a n level or keep the same level.
干预措施: negative emtion working memory(NEWM) training (Behavioral)
Positive attention bias Training (PABT)
The PABT task was a variation of the computerized visual dot-probe task from a previous attention bias modification (ABM) study (Yang, et al., 2015, 2016). The stimuli present 2000 ms. The longer stimulus duration compared to a standard dot-probe task was intended to allow participants to have time to more fully process the content of the stimulus. During the PABT, 27 neutral-positive word pairs were presented 8 times (8 × 27) in each 10-min session.
干预措施: PABT (Behavioral)
placebo (neutral attention bias training, NABT)
The placebo task was identical to the active PABT, except 90% of the probes appeared at the neutral position, 10% at the positive position.During the training, 27 pairs of neutral-positive words are presented 8 times (8 × 27) in each 10-min session. Participants take ten 216-trial sessions for 2 weeks at inital and 8 booster sessions for 2 weeks at 6 months follow-up.
干预措施: placebo (NABT) (Behavioral)
结局指标
主要结局
Onset of a major depressive episode
时间窗: From pre-training to 6 months,12 months. 24 months and 5 years follow-ups after training.
Clinicians interviewed the participants using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS) at initial, 6 months , 12 months and 24 months follow-ups after training and using Structured Clinical Interviews for Diagnostic and Statistical Manual of Mental Disorders, fifth edition ( SCID-5) at 5 years follow-up. The person has at least 4 depressive symptoms and mild to moderate impairment for a probable episode of major depression, or has 5 or more than 5 symptoms and mild to moderate impairment for a definite episode of major depression.
次要结局
- Self-reported depressive symptoms and clinical significant changes(Pre-training, post-training, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 20 weeks, 24weeks, 28weeks, 32 weeks, 12 months, 24 months, and 5 year follow-ups.)
研究者
Wenhui Yang
Professor, the department of psychology, Hunan Normal University
Hunan Normal University