The Effects of Executive Functions and Social Cognition on Mental Health

NCT06213194 | Completed Results

• 1 other identifier: 2023/07-03
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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. 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.

Conditions

Autism or Autistic Traits; Mental Health Disorder; Executive Dysfunction; Social Cognition

Keywords

Autism; Executive Functions; Online Training; Social Cognition; Mental Health

Outcome Measures

Primary Outcomes (6)

• Depression_1

  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.

  Pre-test (baseline), Post-test (immediately after the intervention)

• Anxiety

  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.

  Pre-test (baseline), Post-test (immediately after the intervention)

• Stress

  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.

  Pre-test (baseline), Post-test (immediately after the intervention)

• Cognitive Flexibility - Errors Rate

  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.

  Pre-test (baseline), Post-test (immediately after the intervention)

• Working Memory - Errors Rate

  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

  Pre-test (baseline), Post-test (immediately after the intervention)

• Inhibition - Errors Rate

  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.

  Pre-test (baseline), Post-test (immediately after the intervention)

Secondary Outcomes (2)

• Cognitive Empathy

  pretest and posttest conditions

• Self-Assessment Manikin for Affective Empathy

  pretest and posttest conditions

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: MindZone

Control Group

NO INTERVENTION

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

MindZone OTHER

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18 or above
• Fluent in writing and speaking in Turkish
• No record of any psychiatric disorders
• No record of neurological conditions

You may not qualify if:

• under age 18
• Have any record of psychiatric
• Have any neurological conditions

Sponsors & Collaborators

• Ibn Haldun University: lead

Study Sites (1)

Dilruba Sönmez

Istanbul, Basaksehir, 34480, Turkey (Türkiye)

Location

Related Publications (20)

• 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: 39131758 BACKGROUND

• 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: 32662285 RESULT

• 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: 12039606 RESULT

• 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: 27274255 RESULT

• 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: 31003723 RESULT

• 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: 25256627 RESULT

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

  PMID: 23020641 RESULT

• 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 Jun 8.

  PMID: 29882629 RESULT

• 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.

  PMID: 29772912 RESULT

• 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.

  PMID: 28960841 RESULT

• 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.

  PMID: 26886468 RESULT

• 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):2423-33. doi: 10.1017/S0033291711000377. Epub 2011 Mar 22.

  PMID: 21426604 RESULT

• 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.

  PMID: 35116075 RESULT

• 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. 2021 Jan 23;47(1):108-117. doi: 10.1093/schbul/sbaa085.

  PMID: 32614046 RESULT

• 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.

  PMID: 33170393 RESULT

• 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.biopsycho.2015.09.008. Epub 2015 Sep 25.

  PMID: 26407521 RESULT

• 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.

  PMID: 32075434 RESULT

• Allemand M, Steiger AE, Fend HA. Empathy development in adolescence predicts social competencies in adulthood. J Pers. 2015 Apr;83(2):229-41. doi: 10.1111/jopy.12098. Epub 2014 May 4.

  PMID: 24684661 RESULT

• 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: 10.1177/1362361312453882. Epub 2012 Aug 23.

  PMID: 22917843 RESULT

• 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 epidemiological studies. Mol Psychiatry. 2022 Jan;27(1):281-295. doi: 10.1038/s41380-021-01161-7. Epub 2021 Jun 2.

  PMID: 34079068 RESULT

MeSH Terms

Conditions

Autistic Disorder; Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Personal Satisfaction; Behavior

Results Point of Contact

• Title: Dr. Dilruba Sönmez
• Organization: Ibn Haldun University

dilrubasonmez@gmail.com

905365646640

Study Officials

• Dilruba Sönmez, MA

  Ibn Haldun University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 19, 2024
• Study Start: May 20, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 21, 2024
• Last Updated: March 17, 2025
• Results First Posted: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)