Depressive SymptomsNCT04346771
The Effect of Emotional Working Memory Training on Reducing Depressive Symptoms
A study testing Working memory training and Positive ABMT in people with Depressive Symptoms, run by Hunan Normal University at 1 site in China.
Trial summary
The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing… Read more about this study
- Who is it for?
- Ages 16 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Working memory training and Positive ABMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2019to 10 Jan 2021
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Meet the major and mild depression disorder's criteria
Who cannot join
- 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
The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing depressive symptoms over 1 year after training.
Read the detailed description
Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.
- Conditions
- Depressive Symptoms
- Being tested
- Working memory training, Positive ABMT
- Keywords
- Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation
- Medical subject headings
- Depression, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working memory trainingBehavioural
Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.
Positive ABMTBehavioural
Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Maintaining Positive Working memory | Experimental | Maintaining positive working memory training is based on visual positive works n-back task.In this training, positive words are presented on the pictures of happy face.According to the rules, subjects are required to identify whether the word present currently is as the same type as the word presented n before then click the keys correspondingly.Each training session contains 15 blocks which are consisted with 20+n trails. Receives: Behavioral: Working memory training |
| Positive Attention Bias Modification | Placebo comparator | In the positive attention bias, there are 54 pairs of neutral-negative words, 27 pairs of which are used in the training group and 27 pairs of which are used in the placebo group. The word pairs in each group are repeated 8 times, with a total of 216 trial.Participants received 10 sessions over 2 weeks. 90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position. Receives: Behavioral: Positive ABMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of depressive symptoms
Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
Measured: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Secondary outcomes (1)
Changes of self-reported depressive symptoms
Self-reported depressive symptoms assessed by Beck depression scale-second version (BDI-II)
Measured: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
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 start18 Dec 2019
- Primary completion10 Jan 2021 (estimated)
- Study completion10 Jan 2021 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 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, Principal investigator, Department of Psychology, Hunan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346771
- Sponsor's protocol ID
- EMOTION 2019
- Status last verified
- Apr 2020
- First submitted
- 12 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotional Working Memory Training on Reducing Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04346771
- Acronym / sponsor ID
- EMOTION 2019
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Cognitive control, Emotion, Working memory, Cognitive bias, Emotional regulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hunan Normal UniversityUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 10 Jan 2021 (estimated)
- Study completion
- 10 Jan 2021 (estimated)
- 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 purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to improve depressive symptoms.That is whether emotional working memory training is superior to attention bias modification training or not in reducing depressive symptoms over 1 year after training.
Detailed description
Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintaining Positive Working memory | Experimental | Behavioral: Working memory trainingMaintaining positive working memory training is based on visual positive works n-back task.In this training, positive words are presented on the pictures of happy face.According to the rules, subjects are required to identify whether the word present currently is as the same type as the word presented n before then click the keys correspondingly.Each training session contains 15 blocks which are consisted with 20+n trails. |
| Positive Attention Bias Modification | Placebo comparator | Behavioral: Positive ABMTIn the positive attention bias, there are 54 pairs of neutral-negative words, 27 pairs of which are used in the training group and 27 pairs of which are used in the placebo group. The word pairs in each group are repeated 8 times, with a total of 216 trial.Participants received 10 sessions over 2 weeks. 90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Meet the major and mild depression disorder's criteria
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Working memory trainingParticipants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks. | Behavioural | Maintaining Positive Working memory |
| Positive ABMTParticipants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes. | Behavioural | Positive Attention Bias Modification |
Primary outcome
Changes of depressive symptoms
Time frame: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Depression symptoms tested by clinicians using the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS)
1 secondary outcome
Changes of self-reported depressive symptoms
Time frame: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-training)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
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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 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 Working memory training and Positive ABMT in people with Depressive Symptoms, 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 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 2020. 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?
Results are not available in the source record.
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?
Changes of depressive symptoms (time frame: pre-training, post-training(2 weeks after pre-training), follow-ups(1-week,2-week,4-week,7-week,3-month( booster pre-training), 4-month (booster post-training), 5-month,6-month,12-month after post-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 15 Apr 2020.