Department of Psychology, Hunan Normal University
Changsha, Hunan, 400081, China
NCT Number: NCT04346784
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.
Looking for future studies?
Notify Me16 year–21 year
All sexes
Interventional
Not applicable
Changsha, Hunan, 400081, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A participant with
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.
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.
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.
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.
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.
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.
Hunan Normal University
Other
Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk: A 5-Year Randomized Clinical Trial
Acronym: CTE 2019
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.
Published trials that share one or more normalized conditions with this study.
NCT06147297
Anxiety, Anxiety Disorders
Hong Kong
View Trial DetailsNCT07607834
Anxiety Disorders, Anxiety Symptoms
Taichung, Taiwan
View Trial DetailsNCT05615948
Agnosia, Analgesia
Brooklyn, New York, United States
View Trial DetailsNCT07008209
Anxiety, Anxiety Disorders
Istanbul, Turkey (Türkiye)
View Trial Details