Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05861414 |
Other study ID # |
2022159 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 11, 2022 |
Est. completion date |
March 21, 2023 |
Study information
Verified date |
May 2023 |
Source |
Fujian Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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.