Depressive SymptomsCTE 2019NCT04346784
Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk
A study testing positive emotion working memory(PEWM) training, negative emtion working memory(NEWM) training and PABT in people with Depressive Symptoms and Remited Major Depressive Disorder, run by Hunan Normal University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Depressive Symptoms, Remited Major Depressive Disorder
- What is being tested?
- positive emotion working memory(PEWM) training, negative emtion working memory(NEWM) training and PABT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2019to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scores of the Beck Depression Inventory-II version (BDI-II) of a participant are equal to or more than 14.
Who cannot join
- A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
- Any concurrent psychotherapy;
- Any concurrent psychotropic medication.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Psychology, Hunan Normal University
Changsha, Hunan, 400081
About this study
Official title: Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk: A 5-Year Randomized Clinical Trial
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?
Read more
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.
Read the detailed description
- 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.
- Being tested
- positive emotion working memory(PEWM) training, negative emtion working memory(NEWM) training, PABT, placebo (NABT)
- Keywords
- Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation, Major Depressive Disorder, Prevention, Youth
- Medical subject headings
- Depression, Emotional Regulation, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positive emotion working memory(PEWM) trainingBehavioural
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) trainingBehavioural
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.
PABTBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| positive emotion working memory (PEWM )training | Experimental | 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. Receives: Behavioral: positive emotion working memory(PEWM) training |
| negative emotion working memory (NEWM) training | Experimental | 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. Receives: Behavioral: negative emtion working memory(NEWM) training |
| Positive attention bias Training (PABT) | Experimental | 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. Receives: Behavioral: PABT |
| placebo (neutral attention bias training, NABT) | Placebo comparator | 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. Receives: Behavioral: placebo (NABT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of a major depressive episode
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.
Measured: From pre-training to 6 months,12 months. 24 months and 5 years follow-ups after training.
Secondary outcomes (1)
Self-reported depressive symptoms and clinical significant changes
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start15 Oct 2019
- Primary completion24 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a 5-year randomized double-blind controlled trial designed to test the efficacy of intervention PEWM, or NEWM, or PABT with a placebo (i.e. NABT) for prevention MDD for long-term effect. Measurements of depression-related symptoms will be taken at baseline, post-treatment (i.e., 2-week), 4-, 6-, 9-, 18-, 20-, 26-week (i.e. 6-month), 12-month, 24-month and 5-year follow-ups (after randomization). Structured Clinical Interviews for Diagnostic and Statistical Manual of Mental Disorders, fifth edition( DSM-5, SCID-5) for mood disorders and schizophrenia (First, et al., 2013; Phillips, 2015) will be conducted at baseline, 6-, 12-, 24-month (face-face administered), and 5-year (telephone-administered) follow-ups . The trial is approved by the Ethics Committee of the Hunan Normal University (No. 73).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenhui Yang, Hunan Normal University
- Investigators
- Wenhui Yang, Ph.D, Principal investigator, Department of Psychology, Hunan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346784
- Sponsor's protocol ID
- Cogntive Control EMOTION 2019
- Other IDs
- BBA210038
- Acronym
- CTE 2019
- Status last verified
- Aug 2026
- First submitted
- 12 Apr 2020
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD might not be shared due to participant privacy, lack of informed consent, and the risk of misinterpretation or inappropriate secondary analyses
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control Emotion Training to Prevent Major Depression in Youth At-Risk: A 5-Year Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04346784
- Acronym / sponsor ID
- CTE 2019 / Cogntive Control EMOTION 2019
- Keywords
- Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation, Major Depressive Disorder, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This was a 5-year randomized double-blind controlled trial designed to test the efficacy of intervention PEWM, or NEWM, or PABT with a placebo (i.e. NABT) for prevention MDD for long-term effect. Measurements of depression-related symptoms will be taken at baseline, post-treatment (i.e., 2-week), 4-, 6-, 9-, 18-, 20-, 26-week (i.e. 6-month), 12-month, 24-month and 5-year follow-ups (after randomization). Structured Clinical Interviews for Diagnostic and Statistical Manual of Mental Disorders, fifth edition( DSM-5, SCID-5) for mood disorders and schizophrenia (First, et al., 2013; Phillips, 2015) will be conducted at baseline, 6-, 12-, 24-month (face-face administered), and 5-year (telephone-administered) follow-ups . The trial is approved by the Ethics Committee of the Hunan Normal University (No. 73).
| Arm | Type | Receives |
|---|---|---|
| positive emotion working memory (PEWM )training | Experimental | Behavioral: positive emotion working memory(PEWM) trainingThe 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. |
| negative emotion working memory (NEWM) training | Experimental | Behavioral: negative emtion working memory(NEWM) trainingThe 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. |
| Positive attention bias Training (PABT) | Experimental | Behavioral: PABTThe 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. |
| placebo (neutral attention bias training, NABT) | Placebo comparator | Behavioral: placebo (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. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Scores of the Beck Depression Inventory-II version (BDI-II) of a participant are equal to or more than 14.
Key exclusion criteria (3 listed)
- A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
- Any concurrent psychotherapy;
- Any concurrent psychotropic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| positive emotion working memory(PEWM) trainingParticipants 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. | Behavioural | positive emotion working memory (PEWM )training |
| negative emtion working memory(NEWM) trainingParticipants 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. | Behavioural | negative emotion working memory (NEWM) training |
| PABTParticipants 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. | Behavioural | Positive attention bias Training (PABT) |
| placebo (NABT)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. | Behavioural | placebo (neutral attention bias training, NABT) |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. IPD might not be shared due to participant privacy, lack of informed consent, and the risk of misinterpretation or inappropriate secondary analyses
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenhui Yang, Ph.D principal investigator
Department of Psychology, Hunan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positive emotion working memory(PEWM) training, negative emtion working memory(NEWM) training and PABT in people with Depressive Symptoms and Remited Major Depressive Disorder, run by Hunan Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.