Clinical trial NCT06213194: The Effects of Executive Functions and Social Cognition on Mental Health
Official title: Investigating The Effects of Executive Functions and Social Cognition on the Relationship Between Autistic Traits and Mental Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism or Autistic Traits
Mental Health Disorder
Executive Dysfunction
Social Cognition
Keywords: Autism
Executive Functions
Online Training
Social Cognition
Mental Health
Lead sponsor: Ibn Haldun University
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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. 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Depression_1
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
measure: Anxiety
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
measure: Stress
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
measure: Cognitive Flexibility - Errors Rate
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
measure: Working Memory - Errors Rate
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
measure: Inhibition - Errors Rate
timeFrame: Pre-test (baseline), Post-test (immediately after the intervention)
Secondary outcomes:
measure: Cognitive Empathy
timeFrame: pretest and posttest conditions
measure: Self-Assessment Manikin for Affective Empathy
timeFrame: pretest and posttest conditions
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dilruba Sönmez
state: Basaksehir
Study officials:
affiliation: Ibn Haldun University
name: Dilruba Sönmez, MA
role: PRINCIPAL_INVESTIGATOR
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