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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

China1 site
  • School of Health, Fujian Medical University

    Fuzhou

Other trials in China

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
  1. 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.
  2. 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.
  3. 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.
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 groups in NCT05861414
Study groupRoleWhat they receive
Experimental groupExperimental21 days of emotional working memory training
Receives: Behavioral: EWM-T
control groupNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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.

  1. First posted16 May 2023
  2. Study start11 Oct 2022
  3. Primary completion11 Nov 2022
  4. Study completion21 Mar 2023

Resources

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)
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

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.

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