Depressive SymptomsNCT05861414
Intervention Effect of Emotional Working Memory Training on University Students With Depressive Symptom
A study testing EWM-T in people with Depressive Symptoms, run by Yu-hua Weng at 1 site in China.
Trial summary
Objective: To investigate the effects of emotional working memory training (EWM-T) on depressive symptoms and rumination among university students. Methods: The experimental group comprised 25 participants who underwent 21 days of emotional working memory training, which involved viewing a continuous stream of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- EWM-T
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2022to 21 Mar 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Study from Fujian Medical University, BDI-II scores above 14 points.
Who cannot join
- no suicidal behavior
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To investigate the effects of emotional working memory training (EWM-T) on depressive symptoms and rumination among university students.
Methods: The experimental group comprised 25 participants who underwent 21 days of emotional working memory training, which involved viewing a continuous stream of negative emotional face content on a grid and remembering the faces and locations presented on the grid. The control group consisted of 25 participants. The Beck Depression Inventory-II (BDI-II), the Chinese version of the Character-Digital Breadth Test, and the Ruminative Responses Scale (RRS) were used as the pre- and post-test indicators.
Read the detailed description
- Participants and Design The G*Power 3.1 program was used to determine the recommended sample size is 46 for the study(d=0.35,1-β=80%,α=0.05). This anticipated effect size was based on a working memory training intervention experiment, which had a medium effect size (Unread and Koster 2014). The participants were recruited from Fujian Medical University, and 278 students volunteered to take part in the BDI-Ⅱ. Finally, 50 university students with BDI-II scores above 14 points and with no suicidal behavior were recruited as participants. They were randomly assigned to either an experimental group (n=25) or a control group (n=25). After grouping, the participants' rumination tendency and working memory ability were assessed using the Ruminative Responses Scale (RRS) and the Character-Digital Breadth Test. Subsequently, the experimental group completed twenty-one 20 to 30 minute EWM-T training sessions within one month, and the control group was not treated. A month later, the participants were assessed again for depressive symptoms, working memory ability, and rumination tendency. This study was approved by the Ethics Committee of Fujian Medical University, and all the participants provided signed informed consent. If they were found to be at risk of suicide, the experiment was terminated immediately. If the participants felt uncomfortable, they could withdraw from the experiment at any time, and psychological help was provided if they so desired.
- Materials and Measures 2.1 Beck Depression Inventory-Ⅱ (BDI-Ⅱ) The BDI-II is the most prevalent self-report scale assessing the presence and severity of depressive symptoms. It is a 21-item scale that was used to assess the severity of depressive symptoms in the past two weeks. The scores range from 0 to 63. A higher total score on the scale indicated more severe depressive symptoms. (Wang 2011). 2.2 Ruminative Responses Scale (RRS) The Ruminative Response Scale (RRS) is a scale of 22 items scored on a 4-point Likert scale ranging from 1 (almost never) to 4 (almost always). It was used to assess ruminative thinking, with higher scores indicating a higher degree of ruminative symptoms. It includes three dimensions: symptom rumination, forced thinking, and introspective. The Chinese version of the RRS is suitable for evaluating the rumination thinking of Chinese university students (Han and Yang 2009). 2.3 Character-Digital Breadth Test The experimenter read aloud some combinations of characters and numbers, and after the experimenter finished speaking, the participants first stated the numbers in descending order and then the characters in descending order. For example, in the fourth pass: "8B3A," the participant needed to answer "38AB," and then the test began after the person understood the rules. Different levels (2-9 levels) had various lengths of characters and numbers. The higher the level, the longer the length. Each level contained four items. Scoring was based on the total number of correct items passed (correct number of character digit spans) and the rank of the longest items passed (longest sequence of character digit spans). Each item was completed when all items at a certain level were incorrect. The greater the number of correct items passed, the higher the level of the longest items, the greater the working memory breadth, and the stronger the working memory ability . 2.4 EWM-T This paradigm was adapted from the n-back program described by Jaeggi et al. (2009) and comprised an affective dual n-back task consisting of a series of trials, each of which simultaneously presented a face (for 500 ms) on a 4 × 4 grid on a monitor. Intermediate interval 2500ms, during which, Participants press a button to determine if the current face or position is consistent with the first n. If the position is the same, press "F"; if the face is the same, press "J"; if the face and position are not the same, do not react. Training started at n = 1; if the participants got more than 80% correct, the level of n-back increased by one in the next block. Conversely, if the participants got less than 60% correct, the level of n-back decreased by 1 in the next block. If the 2-back accuracy was greater than 80%, the next block difficulty was upgraded to 3-back; if the 3-back accuracy was less than 60%, the next block difficulty was downgraded to 2-back. The maximum value of n is 8. The 20 daily 20-30 min training sessions consisted of 20 blocks of 20+ n trials. The faces used in this training were selected from the Chinese Facial Emotional Picture System (CFAPS), and 12 faces (six male and six female) with fear, anger, disgust, and sadness were selected as n-back experimental materials.
- Data Analysis An independent samples t-test was used to determine whether the experimental and control groups had varying levels of BDI-II, RRS, and Character-Digital Breadth Test scores at baseline and post-test. T-test determined whether there were significant changes in BDI-II, RRS, and Character-Digital Breadth Test scores from pre-test to post-test in the experimental and control groups.
- Conditions
- Depressive Symptoms
- Being tested
- EWM-T
- Keywords
- Emotional working memory training, Depressive symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EWM-TBehavioural
This paradigm was adapted from the n-back program described by Jaeggi et al. (2009) and comprised an affective dual n-back task consisting of a series of trials, each of which simultaneously presented a face (for 500 ms) on a 4 × 4 grid on a monitor. Intermediate interval 2500ms, during which, Participants press a button to determine if the current face or position is consistent with the first n. If the position is the same, press "F"; if the face is the same, press "J"; if the face and position are not the same, do not react.
The faces used in this training were selected from the Chinese Facial Emotional Picture System (CFAPS), and 12 faces (six male and six female) with fear, anger, disgust, and sadness were selected as n-back experimental materials.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 21 days of emotional working memory training Receives: Behavioral: EWM-T |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory-II (BDI-II) score
Beck Depression Inventory-Ⅱ is the most prevalent self-report scale assessing the presence and severity of depressive symptoms. It is a 21-item scale that was used to assess the severity of depressive symptoms in the past two weeks. The scores range from 0 to 63. A higher total score on the scale indicated more severe depressive symptoms.
Measured: one month
Ruminative Responses Scale (RRS) score
The Ruminative Response Scale (RRS) is a scale of 22 items scored on a 4-point Likert scale ranging from 1 (almost never) to 4 (almost always). It was used to assess ruminative thinking, with higher scores indicating a higher degree of ruminative symptoms. It includes three dimensions: symptom rumination, forced thinking, and introspective.
Measured: one month
The Chinese version of the Character-Digital Breadth Test score
The experimenter read aloud some combinations of characters and numbers, and after the experimenter finished speaking, the participants first stated the numbers in descending order and then the characters in descending order. For example, in the fourth pass: "8B3A," the participant needed to answer "38AB," and then the test began after the person understood the rules. Different levels (2-9 levels) had various lengths of characters and numbers. The higher the level, the longer the length. Each level contained four items. Scoring was based on the total number of correct items passed (correct number of character digit spans) and the rank of the longest items passed (longest sequence of character digit spans). Each item was completed when all items at a certain level were incorrect. The greater the number of correct items passed, the higher the level of the longest items, the greater the working memory breadth, and the stronger the working memory ability .
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start11 Oct 2022
- Primary completion11 Nov 2022
- Study completion21 Mar 2023
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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-hua Weng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yu-hua Weng, Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861414
- Sponsor's protocol ID
- 2022159
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Do not understand Share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effect of Emotional Working Memory Training on University Students With Depressive Symptom
- ClinicalTrials.gov ID
- NCT05861414
- Acronym / sponsor ID
- 2022159
- Conditions
- Depressive Symptoms
- Keywords
- Emotional working memory training, Depressive symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yu-hua WengUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 11 Nov 2022 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 16 May 2023 (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.
Objective: To investigate the effects of emotional working memory training (EWM-T) on depressive symptoms and rumination among university students.
Methods: The experimental group comprised 25 participants who underwent 21 days of emotional working memory training, which involved viewing a continuous stream of negative emotional face content on a grid and remembering the faces and locations presented on the grid. The control group consisted of 25 participants. The Beck Depression Inventory-II (BDI-II), the Chinese version of the Character-Digital Breadth Test, and the Ruminative Responses Scale (RRS) were used as the pre- and post-test indicators.
Detailed description
- Participants and Design The G*Power 3.1 program was used to determine the recommended sample size is 46 for the study(d=0.35,1-β=80%,α=0.05). This anticipated effect size was based on a working memory training intervention experiment, which had a medium effect size (Unread and Koster 2014). The participants were recruited from Fujian Medical University, and 278 students volunteered to take part in the BDI-Ⅱ. Finally, 50 university students with BDI-II scores above 14 points and with no suicidal behavior were recruited as participants. They were randomly assigned to either an experimental group (n=25) or a control group (n=25). After grouping, the participants' rumination tendency and working memory ability were assessed using the Ruminative Responses Scale (RRS) and the Character-Digital Breadth Test. Subsequently, the experimental group completed twenty-one 20 to 30 minute EWM-T training sessions within one month, and the control group was not treated. A month later, the participants were assessed again for depressive symptoms, working memory ability, and rumination tendency. This study was approved by the Ethics Committee of Fujian Medical University, and all the participants provided signed informed consent. If they were found to be at risk of suicide, the experiment was terminated immediately. If the participants felt uncomfortable, they could withdraw from the experiment at any time, and psychological help was provided if they so desired.
- Materials and Measures 2.1 Beck Depression Inventory-Ⅱ (BDI-Ⅱ) The BDI-II is the most prevalent self-report scale assessing the presence and severity of depressive symptoms. It is a 21-item scale that was used to assess the severity of depressive symptoms in the past two weeks. The scores range from 0 to 63. A higher total score on the scale indicated more severe depressive symptoms. (Wang 2011). 2.2 Ruminative Responses Scale (RRS) The Ruminative Response Scale (RRS) is a scale of 22 items scored on a 4-point Likert scale ranging from 1 (almost never) to 4 (almost always). It was used to assess ruminative thinking, with higher scores indicating a higher degree of ruminative symptoms. It includes three dimensions: symptom rumination, forced thinking, and introspective. The Chinese version of the RRS is suitable for evaluating the rumination thinking of Chinese university students (Han and Yang 2009). 2.3 Character-Digital Breadth Test The experimenter read aloud some combinations of characters and numbers, and after the experimenter finished speaking, the participants first stated the numbers in descending order and then the characters in descending order. For example, in the fourth pass: "8B3A," the participant needed to answer "38AB," and then the test began after the person understood the rules. Different levels (2-9 levels) had various lengths of characters and numbers. The higher the level, the longer the length. Each level contained four items. Scoring was based on the total number of correct items passed (correct number of character digit spans) and the rank of the longest items passed (longest sequence of character digit spans). Each item was completed when all items at a certain level were incorrect. The greater the number of correct items passed, the higher the level of the longest items, the greater the working memory breadth, and the stronger the working memory ability . 2.4 EWM-T This paradigm was adapted from the n-back program described by Jaeggi et al. (2009) and comprised an affective dual n-back task consisting of a series of trials, each of which simultaneously presented a face (for 500 ms) on a 4 × 4 grid on a monitor. Intermediate interval 2500ms, during which, Participants press a button to determine if the current face or position is consistent with the first n. If the position is the same, press "F"; if the face is the same, press "J"; if the face and position are not the same, do not react. Training started at n = 1; if the participants got more than 80% correct, the level of n-back increased by one in the next block. Conversely, if the participants got less than 60% correct, the level of n-back decreased by 1 in the next block. If the 2-back accuracy was greater than 80%, the next block difficulty was upgraded to 3-back; if the 3-back accuracy was less than 60%, the next block difficulty was downgraded to 2-back. The maximum value of n is 8. The 20 daily 20-30 min training sessions consisted of 20 blocks of 20+ n trials. The faces used in this training were selected from the Chinese Facial Emotional Picture System (CFAPS), and 12 faces (six male and six female) with fear, anger, disgust, and sadness were selected as n-back experimental materials.
- Data Analysis An independent samples t-test was used to determine whether the experimental and control groups had varying levels of BDI-II, RRS, and Character-Digital Breadth Test scores at baseline and post-test. T-test determined whether there were significant changes in BDI-II, RRS, and Character-Digital Breadth Test scores from pre-test to post-test in the experimental and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: EWM-T21 days of emotional working memory training |
| control group | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Study from Fujian Medical University, BDI-II scores above 14 points.
Key exclusion criteria (1 listed)
- no suicidal behavior
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 |
|---|---|---|
| EWM-TThis paradigm was adapted from the n-back program described by Jaeggi et al. (2009) and comprised an affective dual n-back task consisting of a series of trials, each of which simultaneously presented a face (for 500 ms) on a 4 × 4 grid on a monitor. Intermediate interval 2500ms, during which, Participants press a button to determine if the current face or position is consistent with the first n. If the position is the same, press "F"; if the face is the same, press "J"; if the face and position are not the same, do not react. The faces used in this training were selected from the Chinese Facial Emotional Picture System (CFAPS), and 12 faces (six male and six female) with fear, anger, disgust, and sadness were selected as n-back experimental materials. | Behavioural | Experimental group |
Primary outcome
Beck Depression Inventory-II (BDI-II) score
Time frame: one month
Beck Depression Inventory-Ⅱ is the most prevalent self-report scale assessing the presence and severity of depressive symptoms. It is a 21-item scale that was used to assess the severity of depressive symptoms in the past two weeks. The scores range from 0 to 63. A higher total score on the scale indicated more severe depressive symptoms.
Ruminative Responses Scale (RRS) score
Time frame: one month
The Ruminative Response Scale (RRS) is a scale of 22 items scored on a 4-point Likert scale ranging from 1 (almost never) to 4 (almost always). It was used to assess ruminative thinking, with higher scores indicating a higher degree of ruminative symptoms. It includes three dimensions: symptom rumination, forced thinking, and introspective.
The Chinese version of the Character-Digital Breadth Test score
Time frame: one month
The experimenter read aloud some combinations of characters and numbers, and after the experimenter finished speaking, the participants first stated the numbers in descending order and then the characters in descending order. For example, in the fourth pass: "8B3A," the participant needed to answer "38AB," and then the test began after the person understood the rules. Different levels (2-9 levels) had various lengths of characters and numbers. The higher the level, the longer the length. Each level contained four items. Scoring was based on the total number of correct items passed (correct number of character digit spans) and the rank of the longest items passed (longest sequence of character digit spans). Each item was completed when all items at a certain level were incorrect. The greater the number of correct items passed, the higher the level of the longest items, the greater the working memory breadth, and the stronger the working memory ability .
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 16 May 2023.
- Individual participant dataSharing planned: Undecided. Do not understand Share IPD
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EWM-T in people with Depressive Symptoms, run by Yu-hua Weng 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: finished, as of the sponsor's last update on 16 May 2023. 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. 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?
Beck Depression Inventory-II (BDI-II) score (time frame: one month). The study lists 3 primary outcomes in all. 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 16 May 2023.