The Effects of Executive Functions and Social Cognition on Mental Health

Mental Health Disorder Clinical Trial

Official title:

Investigating The Effects of Executive Functions and Social Cognition on the Relationship Between Autistic Traits and Mental Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213194
• Other study ID #: 2023/07-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: August 20, 2024

Study information

• Verified date: March 2024
• Source: Ibn Haldun University
• Contact: Dilruba Sönmez, MA
• Phone: 00905365646640
• Email: dilruba.sonmez[@]stu.ihu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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. Therefore, four main hypotheses will be addressed: 1. 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). 2. 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). 3. 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. 4. Online training in executive functions and social cognitive skills will promote mental health by reducing distress, depression, and anxiety symptoms in the current sample. Participants 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.

Description:

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. Previous 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. The 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. Using 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 20, 2024
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. aged 18 or above

2. Fluent in writing and speaking in Turkish

3. No record of any psychiatric disorders

4. No record of neurological conditions

Exclusion Criteria:

1. under age 18

2. Have any record of psychiatric

3. Have any neurological conditions

Related Conditions & MeSH terms

• Autistic Disorder
• Executive Dysfunction
• Mental Disorders
• Mental Health Disorder
• Social Cognition

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Dilruba Sönmez	Istanbul	Basaksehir

Sponsors (1)

Lead Sponsor	Collaborator
Ibn Haldun University

Country where clinical trial is conducted

Turkey, 

References & Publications (20)

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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 — View 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 2 — View 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 — View Citation

Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27. — View Citation

Eussen ML, Van Gool AR, Verheij F, De Nijs PF, Verhulst FC, Greaves-Lord K. The association of quality of social relations, symptom severity and intelligence with anxiety in children with autism spectrum disorders. Autism. 2013 Nov;17(6):723-35. doi: 10.1 — View 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. Epub 2018 — View Citation

Gambin M, Sharp C. Relations between empathy and anxiety dimensions in inpatient adolescents. Anxiety Stress Coping. 2018 Jul;31(4):447-458. doi: 10.1080/10615806.2018.1475868. Epub 2018 May 17. — View Citation

Gardiner E, Iarocci G. Everyday executive function predicts adaptive and internalizing behavior among children with and without autism spectrum disorder. Autism Res. 2018 Feb;11(2):284-295. doi: 10.1002/aur.1877. Epub 2017 Sep 27. — View Citation

Gokcen E, Frederickson N, Petrides KV. Theory of Mind and Executive Control Deficits in Typically Developing Adults and Adolescents with High Levels of Autism Traits. J Autism Dev Disord. 2016 Jun;46(6):2072-2087. doi: 10.1007/s10803-016-2735-3. — View Citation

Lundstrom S, Chang Z, Kerekes N, Gumpert CH, Rastam M, Gillberg C, Lichtenstein P, Anckarsater H. Autistic-like traits and their association with mental health problems in two nationwide twin cohorts of children and adults. Psychol Med. 2011 Nov;41(11):24 — View Citation

Mason D, Happe F. The role of alexithymia and autistic traits in predicting quality of life in an online sample. Res Autism Spectr Disord. 2022 Feb;90:None. doi: 10.1016/j.rasd.2021.101887. — View Citation

Nahum M, Lee H, Fisher M, Green MF, Hooker CI, Ventura J, Jordan JT, Rose A, Kim SJ, Haut KM, Merzenich MM, Vinogradov S. Online Social Cognition Training in Schizophrenia: A Double-Blind, Randomized, Controlled Multi-Site Clinical Trial. Schizophr Bull. — View Citation

Sandgreen H, Frederiksen LH, Bilenberg N. Digital Interventions for Autism Spectrum Disorder: A Meta-analysis. J Autism Dev Disord. 2021 Sep;51(9):3138-3152. doi: 10.1007/s10803-020-04778-9. Epub 2020 Nov 10. — View Citation

Sari BA, Koster EH, Pourtois G, Derakshan N. Training working memory to improve attentional control in anxiety: A proof-of-principle study using behavioral and electrophysiological measures. Biol Psychol. 2016 Dec;121(Pt B):203-212. doi: 10.1016/j.biopsyc — View Citation

Solmi M, Radua J, Olivola M, Croce E, Soardo L, Salazar de Pablo G, Il Shin J, Kirkbride JB, Jones P, Kim JH, Kim JY, Carvalho AF, Seeman MV, Correll CU, Fusar-Poli P. Age at onset of mental disorders worldwide: large-scale meta-analysis of 192 epidemiolo — View Citation

Sönmez, D., & Jordan, T. R. (2023). Investigating associations between cognitive empathy, affective empathy and anxiety in adolescents with autism spectrum disorder. International Journal of Developmental Disabilities, 1-9.

Zelazo PD. Executive Function and Psychopathology: A Neurodevelopmental Perspective. Annu Rev Clin Psychol. 2020 May 7;16:431-454. doi: 10.1146/annurev-clinpsy-072319-024242. Epub 2020 Feb 19. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression	Depression Anxiety Stress Scale 21 will be used to measure depression outcome	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Depression	Patient Health Questionnaire - 9 will be used to measure depression outcome	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Anxiety	Depression Anxiety Stress Scale - 21 will be used to measure anxiety outcome	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Anxiety	Generalized Anxiety Disorder Questionnaire - 7 will be used to measure anxiety outcome	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Stress	Depression Anxiety Stress Scale - 21 will be used to measure stress outcome.	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Cognitive Flexibility - Reaction Time	Cognitive flexibility - Reaction Time will be measured by the Wisconsin Card Sorting Task .	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Cognitive Flexibility - Accuracy Rate	Cognitive flexibility - Accuracy Rate will be measured by the Wisconsin Card Sorting Task.	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Working Memory - Reaction Time	Working memory - Reaction Time will be measured by the N-back task.	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Working Memory - Accuracy Rate	Working memory - Accuracy Rate will be measured by the N-back task.	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Inhibition - Reaction Time	Inhibition - Reaction Time will be measured by Go/No Go task	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)
Primary	Inhibition - Accuracy Rate	Inhibition - Accuracy Rate will be measured by Go/No Go task.	Pre-test (baseline), Post-test (immediately after the intervention), and Follow up (up to 4 weeks)