Trial Outcomes & Findings for The Effects of Executive Functions and Social Cognition on Mental Health (NCT NCT06213194)
NCT ID: NCT06213194
Last Updated: 2025-03-17
Results Overview
Depression Anxiety Stress Scale 21 will be used to measure depression outcome. Higher scores mean higher depressive symptoms. The minimum and maximum scores are 0-21, respectively.
COMPLETED
NA
178 participants
Pre-test (baseline), Post-test (immediately after the intervention)
2025-03-17
Participant Flow
Online data collection were used.
Participants are under the age of 18, and who have any record of psychiatric or physical conditions excluded from the study.
Participant milestones
| Measure |
Experimental Group
It combines social cognitive and executive functions skills and it will be present on the designed website and they will participate in the intervention online. After participants are assigned the experimental group the 6-week training program will start and they cannot access the next week before completing the previous week. Each week's will last about 75 minutes. The training includes social cognitive skills including cognitive and affective empathy and executive functions.
MindZone: The name of the online training will be MindZone. It consists of combined game-based social cognitive and executive functions skills, and it will be presented on the training website. There is no consensus about the length of time for the training in the literature, so the average time for the training process will be used. This means that the training will last 6 weeks, 5 hours in total. To satisfy the training requirement, 50 mins for each week of play will be expected from participants each week. Before each game, a brief introduction about the game will be presented and participants will get feedback about their progress. Each participant will conduct the tasks in a different random order. After 6 weeks, a post-test will be completed, and follow-up scores will be obtained after a month. All tasks were designed according to the five intervention areas: working memory, cognitive flexibility, inhibition, cognitive empathy and affective empathy based on the literature.
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Control Group
This group will not take the training until the follow-up test. After the study will be done, the training program will be offered to the control group as well.
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|---|---|---|
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Overall Study
STARTED
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89
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89
|
|
Overall Study
COMPLETED
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31
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34
|
|
Overall Study
NOT COMPLETED
|
58
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We included participants who completed the post-test condition.
Baseline characteristics by cohort
| Measure |
Experimental Group
n=89 Participants
It combines social cognitive and executive functions skills and it will be present on the designed website and they will participate in the intervention online. After participants are assigned the experimental group the 6-week training program will start and they cannot access the next week before completing the previous week. Each week's will last about 75 minutes. The training includes social cognitive skills including cognitive and affective empathy and executive functions.
MindZone: The name of the online training will be MindZone. It consists of combined game-based social cognitive and executive functions skills, and it will be presented on the training website. There is no consensus about the length of time for the training in the literature, so the average time for the training process will be used. This means that the training will last 6 weeks, 7.5 hours in total. To satisfy the training requirement, 1.15 hours (75 mins) of play will be expected from participants each week. Before each game, a brief introduction about the game will be presented and participants will get feedback about their progress. Each participant will conduct the tasks in a different random order. After 6 weeks, a post-test will be completed, and follow-up scores will be obtained after a month. All tasks were designed according to the five intervention areas: working memory, cognitive flexibility, inhibition, cognitive empathy and affective empathy based on the literature.
|
Control Group
n=89 Participants
This group will not take the training until the follow-up test. After the study will be done, the training program will be offered to the control group as well.
|
Total
n=178 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=89 Participants
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0 Participants
n=89 Participants
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0 Participants
n=178 Participants
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Age, Categorical
Between 18 and 65 years
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89 Participants
n=89 Participants
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89 Participants
n=89 Participants
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178 Participants
n=178 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=89 Participants
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0 Participants
n=89 Participants
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0 Participants
n=178 Participants
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Age, Continuous
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27.58 years
STANDARD_DEVIATION 5.95 • n=31 Participants • We included participants who completed the post-test condition.
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27.24 years
STANDARD_DEVIATION 6.13 • n=34 Participants • We included participants who completed the post-test condition.
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27.41 years
STANDARD_DEVIATION 6.02 • n=65 Participants • We included participants who completed the post-test condition.
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Sex: Female, Male
Female
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28 Participants
n=31 Participants • We included the participants who completed the post-test condition.
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29 Participants
n=34 Participants • We included the participants who completed the post-test condition.
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57 Participants
n=65 Participants • We included the participants who completed the post-test condition.
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Sex: Female, Male
Male
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3 Participants
n=31 Participants • We included the participants who completed the post-test condition.
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5 Participants
n=34 Participants • We included the participants who completed the post-test condition.
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8 Participants
n=65 Participants • We included the participants who completed the post-test condition.
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Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Turkey
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89 Participants
n=89 Participants
|
89 Participants
n=89 Participants
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178 Participants
n=178 Participants
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: Experimental and control groups
Depression Anxiety Stress Scale 21 will be used to measure depression outcome. Higher scores mean higher depressive symptoms. The minimum and maximum scores are 0-21, respectively.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
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|---|---|---|
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Depression_1
Pretest
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9.87 score on a scale
Standard Deviation 3.72
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10.24 score on a scale
Standard Deviation 4.02
|
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Depression_1
Posttest
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7.65 score on a scale
Standard Deviation 2.57
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9.15 score on a scale
Standard Deviation 4.13
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: experimental and control groups
Depression Anxiety Stress Scale - 21 will be used to measure anxiety outcome. Higher scores mean higher anxiety symptoms. The minimum and maximum scores are 0-21, respectively.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
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|---|---|---|
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Anxiety
Pretest
|
9.42 score on a scale
Standard Deviation 3.70
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9.44 score on a scale
Standard Deviation 3.94
|
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Anxiety
Posttest
|
6.74 score on a scale
Standard Deviation 2.94
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8.03 score on a scale
Standard Deviation 4.20
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: experimental group
Depression Anxiety Stress Scale - 21 will be used to measure stress outcome. Higher scores indicate higher stress. The minimum and maximum scores are 0-21, respectively.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
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|---|---|---|
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Stress
Pretest
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7.61 score on a scale
Standard Deviation 3.98
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6.32 score on a scale
Standard Deviation 3.98
|
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Stress
Posttest
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5.58 score on a scale
Standard Deviation 3.56
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7.79 score on a scale
Standard Deviation 4.05
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: experimental group vs. control group
Cognitive flexibility - Errors Rate will be measured by the Wisconsin Card Sorting Task. Higher errors indicate lower scores on cognitive flexibility. During the task, 400 cards in two blocks are displayed on the screen and the sorting rule changes after every 10 cards. Maximum score is 400 and minimum score is 0.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
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|---|---|---|
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Cognitive Flexibility - Errors Rate
Pretest
|
21 score on a scale
Standard Deviation 10
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22 score on a scale
Standard Deviation 4
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Cognitive Flexibility - Errors Rate
Posttest
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40 score on a scale
Standard Deviation 20
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37 score on a scale
Standard Deviation 15
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: experimental group
Working memory - Errors Rate will be measured by the N-back task. Higher errors indicate lower working memory scores. Maximum score is 400, minimum score is 0
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
|
|---|---|---|
|
Working Memory - Errors Rate
Pretest
|
20.65 score on a scale
Standard Deviation 9.19
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15.09 score on a scale
Standard Deviation 11.94
|
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Working Memory - Errors Rate
Posttest
|
13.13 score on a scale
Standard Deviation 8.59
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10.50 score on a scale
Standard Deviation 7.55
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PRIMARY outcome
Timeframe: Pre-test (baseline), Post-test (immediately after the intervention)Population: experimental group vs. control group
Inhibition - Errors Rate will be measured by Go/No Go task. Higher scores indicate lower inhibition. There are 12 blocks of 50 trials each. Commission errors (i.e., incorrectly responding to no-go trials) were measured. Maximum score is 600. Minimum score is 0.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
|
|---|---|---|
|
Inhibition - Errors Rate
Pretest
|
5.48 score on a scale
Standard Deviation 6.59
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3.24 score on a scale
Standard Deviation 5.18
|
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Inhibition - Errors Rate
Posttest
|
4.48 score on a scale
Standard Deviation 3.37
|
3.85 score on a scale
Standard Deviation 3.21
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SECONDARY outcome
Timeframe: pretest and posttest conditionsPopulation: experimental and control groups
The Eyes Test were used to measure cognitive empathy. Higher scores indicate higher cognitive empathy scores. Maximum score is 36, minimum score is 0.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
|
|---|---|---|
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Cognitive Empathy
Pretest
|
24.45 score on a scale
Standard Deviation 3.88
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25.65 score on a scale
Standard Deviation 3.27
|
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Cognitive Empathy
Posttest
|
25.39 score on a scale
Standard Deviation 4.29
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26.59 score on a scale
Standard Deviation 3.44
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SECONDARY outcome
Timeframe: pretest and posttest conditionsPopulation: experimental and control groups
Self Assessment Manikin was used to measure affective empathy. Valence scores for each emotion were obtained by summing responses for all images. The maximum score is 270, and the minimum score is 30. Higher scores indicate better affective empathy.
Outcome measures
| Measure |
Experimental Group
n=31 Participants
Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)
|
Control Group
n=34 Participants
depression subscale of DASS-21
|
|---|---|---|
|
Self-Assessment Manikin for Affective Empathy
Pretest
|
130.16 score on a scale
Standard Deviation 20.43
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119.35 score on a scale
Standard Deviation 16.88
|
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Self-Assessment Manikin for Affective Empathy
Posttest
|
126.16 score on a scale
Standard Deviation 12.90
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117.38 score on a scale
Standard Deviation 16.61
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Adverse Events
Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place