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Completed

NCT Number: NCT04346784

Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk

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.

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Key information

Age range

16 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology, Hunan Normal University

Changsha, Hunan, 400081, China

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Scores of the Beck Depression Inventory-II version (BDI-II) of a participant are equal to or more than 14.

Exclusion criteria

A participant with

  • A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
  • Any concurrent psychotherapy;
  • Any concurrent psychotropic medication.

Treatment and study plan

positive emotion working memory(PEWM) training

Behavioral

Participants take 10 sessions of positive emotion working memory training with n-bak task of positive words for two-week at itinal and 8 booster sessions at 6 months follow-up.

negative emtion working memory(NEWM) training

Behavioral

Participants take ten 16 × (21 + n) trial sessions of NEWM with dual n-back task with sad facial pictures for visual modality and sad words for auditory modality for 2 weeks at initial and 8 booster sessions for 2 weeks at 6 months follow-up.

PABT

Behavioral

Participants take ten 216-trial sessions of PABT with 90% probe dot fallen on positive words for 2 weeks and eight 216-trial booster sessions for 2 weeks at 6 months follow-up.

placebo (NABT)

Behavioral

Participants take ten 216-trial sessions of placebo training with 90% probe-dot fallen on neutral concrete words for 2 weeks at initial and 8 booster sessions for 2 weeks at 6 month follow-up.

Primary outcomes

  1. Onset of a major depressive episode

    Time frame: 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.

Secondary outcomes

  1. Self-reported depressive symptoms and clinical significant changes

    Time frame: 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.

    Self-reported depressive symptoms assessed by Beck Depression Inventory-the second version (BDI-II). The BDI-II contains 21 questions, each with a score from 0 to 3. The total scores range form 21 to 60. To evaluate clinical significant changes of depressive symptoms, we follow the procedures outlined by Jacobson and Truax (Jacobson & Truax, 1991) . A participant is classified as meeting criteria for clinically significant change if (a) the post-training score falls within the range (mean ± 2 SDs) of the nonclinical population on the basis of BDI-II data (Yang, Wu, &Peng, 2012), and (b) if they display a statistically reliable reduction in scores from pre- to post- or to folloow-up assessment based to the reliable change index.

Sponsors and collaborators

Lead sponsor

Hunan Normal University

Other

Registry information

Official study title

Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk: A 5-Year Randomized Clinical Trial

Acronym: CTE 2019

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2020
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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