Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-26 @ 12:00 AM
Study NCT ID:
NCT06213194
Status:
COMPLETED
Last Update Posted:
2025-03-17
First Post:
2023-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effects of Executive Functions and Social Cognition on Mental Health
Sponsor:
Organization:
Raw JSON
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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.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': '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.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression_1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'Pretest Mean (SD) :9.87(3.72) Posttest Mean (SD): 7.65 (2.57)'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'depression subscale of DASS-21'}], 'classes': [{'title': 'Pretest', 'categories': [{'measurements': [{'value': '9.87', 'spread': '3.72', 'groupId': 'OG000'}, {'value': '10.24', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '7.65', 'spread': '2.57', 'groupId': 'OG000'}, {'value': '9.15', 'spread': '4.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': 'Depression Anxiety Stress Scale 21 will be used to measure depression outcome. 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Higher scores indicate higher stress. 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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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'experimental group vs. control group'}, {'type': 'PRIMARY', 'title': 'Working Memory - Errors Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'Errors rate'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'Control group errors scores'}], 'classes': [{'title': 'Pretest', 'categories': [{'measurements': [{'value': '20.65', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '15.09', 'spread': '11.94', 'groupId': 'OG001'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '13.13', 'spread': '8.59', 'groupId': 'OG000'}, {'value': '10.50', 'spread': '7.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'experimental group'}, {'type': 'PRIMARY', 'title': 'Inhibition - Errors Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'Inhibitory Control - Errors rate'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'control group errors scores'}], 'classes': [{'title': 'Pretest', 'categories': [{'measurements': [{'value': '5.48', 'spread': '6.59', 'groupId': 'OG000'}, {'value': '3.24', 'spread': '5.18', 'groupId': 'OG001'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '4.48', 'spread': '3.37', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '3.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'experimental group vs. control group'}, {'type': 'SECONDARY', 'title': 'Cognitive Empathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'accuracy'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'accuracy'}], 'classes': [{'title': 'Pretest', 'categories': [{'measurements': [{'value': '24.45', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '25.65', 'spread': '3.27', 'groupId': 'OG001'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '25.39', 'spread': '4.29', 'groupId': 'OG000'}, {'value': '26.59', 'spread': '3.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pretest and posttest conditions', 'description': 'The Eyes Test were used to measure cognitive empathy. Higher scores indicate higher cognitive empathy scores. Maximum score is 36, minimum score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'experimental and control groups'}, {'type': 'SECONDARY', 'title': 'Self-Assessment Manikin for Affective Empathy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental Group', 'description': 'summing the scores for affective empathy performance task'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'summing the scores for affective empathy performance task'}], 'classes': [{'title': 'Pretest', 'categories': [{'measurements': [{'value': '130.16', 'spread': '20.43', 'groupId': 'OG000'}, {'value': '119.35', 'spread': '16.88', 'groupId': 'OG001'}]}]}, {'title': 'Posttest', 'categories': [{'measurements': [{'value': '126.16', 'spread': '12.90', 'groupId': 'OG000'}, {'value': '117.38', 'spread': '16.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pretest and posttest conditions', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'experimental and control groups'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Experimental Group', 'description': "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.\n\nMindZone: 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."}, {'id': 'FG001', 'title': 'Control Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '89'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '55'}]}]}], 'recruitmentDetails': 'Online data collection were used.', 'preAssignmentDetails': 'Participants are under the age of 18, and who have any record of psychiatric or physical conditions excluded from the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Experimental Group', 'description': "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.\n\nMindZone: 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."}, {'id': 'BG001', 'title': 'Control Group', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.58', 'spread': '5.95', 'groupId': 'BG000'}, {'value': '27.24', 'spread': '6.13', 'groupId': 'BG001'}, {'value': '27.41', 'spread': '6.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'We included participants who completed the post-test condition.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'We included the participants who completed the post-test condition.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-03-07', 'size': 188661, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-07T06:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'To reduce biases, a single-blind procedure will be applied. It will be provided basic information about topics including social-cognitive skills and mental health but no detailed description of training will be given.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All participants would be assigned randomly to the experimental group and control group (wait-list condition) to see whether the combined training program is effective for the general population.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 178}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-07', 'studyFirstSubmitDate': '2023-12-14', 'resultsFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2024-01-09', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-07', 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression_1', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.'}, {'measure': 'Anxiety', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.'}, {'measure': 'Stress', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.'}, {'measure': 'Cognitive Flexibility - Errors Rate', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.'}, {'measure': 'Working Memory - Errors Rate', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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'}, {'measure': 'Inhibition - Errors Rate', 'timeFrame': 'Pre-test (baseline), Post-test (immediately after the intervention)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cognitive Empathy', 'timeFrame': 'pretest and posttest conditions', 'description': 'The Eyes Test were used to measure cognitive empathy. Higher scores indicate higher cognitive empathy scores. Maximum score is 36, minimum score is 0.'}, {'measure': 'Self-Assessment Manikin for Affective Empathy', 'timeFrame': 'pretest and posttest conditions', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism', 'Executive Functions', 'Online Training', 'Social Cognition', 'Mental Health'], 'conditions': ['Autism or Autistic Traits', 'Mental Health Disorder', 'Executive Dysfunction', 'Social Cognition']}, 'referencesModule': {'references': [{'pmid': '39131758', 'type': 'BACKGROUND', 'citation': 'Sonmez D, Jordan TR. Investigating associations between cognitive empathy, affective empathy and anxiety in adolescents with autism spectrum disorder. Int J Dev Disabil. 2023 Jan 9;70(5):957-965. doi: 10.1080/20473869.2022.2163605. eCollection 2024.'}, {'pmid': '32662285', 'type': 'RESULT', 'citation': 'Albantakis L, Brandi ML, Zillekens IC, Henco L, Weindel L, Thaler H, Schliephake L, Timmermans B, Schilbach L. Alexithymic and autistic traits: Relevance for comorbid depression and social phobia in adults with and without autism spectrum disorder. Autism. 2020 Nov;24(8):2046-2056. doi: 10.1177/1362361320936024. Epub 2020 Jul 14.'}, {'pmid': '12039606', 'type': 'RESULT', 'citation': 'Baron-Cohen S. The extreme male brain theory of autism. Trends Cogn Sci. 2002 Jun 1;6(6):248-254. doi: 10.1016/s1364-6613(02)01904-6.'}, {'pmid': '27274255', 'type': 'RESULT', 'citation': 'Craig F, Margari F, Legrottaglie AR, Palumbi R, de Giambattista C, Margari L. A review of executive function deficits in autism spectrum disorder and attention-deficit/hyperactivity disorder. Neuropsychiatr Dis Treat. 2016 May 12;12:1191-202. doi: 10.2147/NDT.S104620. eCollection 2016.'}, {'pmid': '31003723', 'type': 'RESULT', 'citation': "Dell'Osso L, Carpita B, Muti D, Morelli V, Salarpi G, Salerni A, Scotto J, Massimetti G, Gesi C, Ballerio M, Signorelli MS, Luciano M, Politi P, Aguglia E, Carmassi C, Maj M. Mood symptoms and suicidality across the autism spectrum. Compr Psychiatry. 2019 May;91:34-38. doi: 10.1016/j.comppsych.2019.03.004. Epub 2019 Apr 3."}, {'pmid': '25256627', 'type': 'RESULT', 'citation': 'de Vries M, Prins PJ, Schmand BA, Geurts HM. Working memory and cognitive flexibility-training for children with an autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2015 May;56(5):566-76. doi: 10.1111/jcpp.12324. Epub 2014 Sep 26.'}, {'pmid': '23020641', 'type': 'RESULT', 'citation': 'Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.'}, {'pmid': '29882629', 'type': 'RESULT', 'citation': 'Fietz J, Valencia N, Silani G. Alexithymia and autistic traits as possible predictors for traits related to depression, anxiety, and stress: A multivariate statistical approach. J Eval Clin Pract. 2018 Aug;24(4):901-908. doi: 10.1111/jep.12961. 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Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to analyze the effects of executive functions (EFs) and social-cognitive abilities on the associations between autistic traits and mental health indicators (depression, anxiety, and stress). Moreover, the study will produce online training modules for executive functions and social cognition, aimed at reducing the likelihood of adverse mental health outcomes in individuals with and without elevated autistic traits.\n\nTherefore, four main hypotheses will be addressed:\n\n1. Revealing the mediating role of executive functions (cognitive flexibility, inhibitory control, and working memory) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).\n2. Revealing the mediating role of social cognitive skills (cognitive empathy and affective empathy) will help predict the association between autistic traits and mental health symptoms (anxiety, depression, and stress).\n3. Online training in executive functions and social cognitive skills will help develop executive functions (working memory, inhibitory control, and cognitive flexibility) and social cognitive skills (cognitive empathy and affective empathy) in the current sample.\n4. Online training in executive functions and social cognitive skills will promote mental health by reducing distress, depression, and anxiety symptoms in the current sample.\n\nParticipants will be between the ages of 18-35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Using a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined EFs and social cognition online training for mental health symptoms.', 'detailedDescription': "Autism spectrum disorder (ASD) refers to a neurodevelopmental condition that is associated with impairments in social and cognitive functions, repetitive behaviors, and restricted interests, while autistic traits refer to a subclinical level of ASD and its symptoms distributed in the general population. Previous studies have identified people with elevated autistic traits who show susceptibility to other mental health conditions such as anxiety disorders, mood disorders, borderline personality disorder, internet addiction, conduct disorder, substance abuse, and suicidal risk in the general population. Although there is no identifiable explanation of susceptibility to other mental health conditions, the presence of social and cognitive impairments including problems in executive functions and social cognitive skills might be contributing factors.\n\nPrevious research indicated that social cognitive skills such as cognitive and affective empathy and executive functions including working memory, inhibitory control and cognitive flexibility play important roles in physical and mental health, quality of life, social competence, school and job success, marital harmony, and public safety. Nevertheless, although autistic traits increase susceptibility to other mental health conditions, no study so far has focused on examining the relationships among autistic traits, executive functions, and social cognitive skills to design intervention and prevention programs for mental health conditions and quality of life in both general and clinical populations.\n\nThe primary purpose of the research is to investigate the effects of executive functions and social cognitive skills on the relationship between autistic traits and mental health symptoms that would be significant for designing intervention and prevention programs. The second purpose of the research is to design online executive functions and social cognitive training that might help to reduce vulnerability to negative effects on mental health symptoms in the general population regarding elevated autistic traits.\n\nUsing a longitudinal design including pre-test, post-test, and follow-up conditions to test the effectiveness of combined executive functions (EFs) and social cognition online training via computers, tablets, or smartphones for mental health symptoms (depression, anxiety, and stress). This study's independent variables are executive functions (cognitive flexibility, inhibition, and working memory) and social cognition (cognitive empathy and affective empathy). Dependent variables are mental health scores (depression, anxiety, and stress symptoms). Participants will be between the ages of 18 and 35 because previous findings indicate that the age of onset of various mental health problems is between the ages of 17 and 35. Participants will be randomly assigned to the experimental and control groups. Online-based training will consist of combined executive functions and social cognitive (i.e., cognitive empathy and affective empathy) tasks. The length of the training each week will be 75 minutes based on the previous studies. Three within conditions will be present: pre-test, post-test, and follow-up. The primary outcomes of the study are mental health symptoms (anxiety, depression, stress), EFs (working memory, cognitive flexibility, and inhibition), and social cognition (cognitive and affective empathy)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18 or above\n2. Fluent in writing and speaking in Turkish\n3. No record of any psychiatric disorders\n4. No record of neurological conditions\n\nExclusion Criteria:\n\n1. under age 18\n2. Have any record of psychiatric\n3. Have any neurological conditions'}, 'identificationModule': {'nctId': 'NCT06213194', 'briefTitle': 'The Effects of Executive Functions and Social Cognition on Mental Health', 'organization': {'class': 'OTHER', 'fullName': 'Ibn Haldun University'}, 'officialTitle': 'Investigating The Effects of Executive Functions and Social Cognition on the Relationship Between Autistic Traits and Mental Health', 'orgStudyIdInfo': {'id': '2023/07-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': "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.", 'interventionNames': ['Other: MindZone']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': '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.'}], 'interventions': [{'name': 'MindZone', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34480', 'city': 'Istanbul', 'state': 'Basaksehir', 'country': 'Turkey (Türkiye)', 'facility': 'Dilruba Sönmez', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Dilruba Sönmez, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ibn Haldun University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To ensure the ethical rights of the participants, the data will be available only for current research unless the participants give permission.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ibn Haldun University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist', 'investigatorFullName': 'Dilruba Sönmez', 'investigatorAffiliation': 'Ibn Haldun University'}}}}