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The Effects of Executive Functions and Social Cognition on Mental Health
NA trial testing MindZone in Autism or Autistic Traits in 178 participants. Completed in 21 October 2024.
| Lead sponsor | Ibn Haldun University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 178 |
| Start date | 20 May 2024 |
| Primary completion | 10 October 2024 |
| Estimated completion | 21 October 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Ibn Haldun University
Adults 18 to 40, any sex, with Autism or Autistic Traits or Mental Health Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 9.87 | ± 3.72 |
| Control Group | 10.24 | ± 4.02 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 7.65 | ± 2.57 |
| Control Group | 9.15 | ± 4.13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 9.42 | ± 3.70 |
| Control Group | 9.44 | ± 3.94 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 6.74 | ± 2.94 |
| Control Group | 8.03 | ± 4.20 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 7.61 | ± 3.98 |
| Control Group | 6.32 | ± 3.98 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 5.58 | ± 3.56 |
| Control Group | 7.79 | ± 4.05 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 21 | ± 10 |
| Control Group | 22 | ± 4 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 40 | ± 20 |
| Control Group | 37 | ± 15 |
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
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 20.65 | ± 9.19 |
| Control Group | 15.09 | ± 11.94 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 13.13 | ± 8.59 |
| Control Group | 10.50 | ± 7.55 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 5.48 | ± 6.59 |
| Control Group | 3.24 | ± 5.18 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 4.48 | ± 3.37 |
| Control Group | 3.85 | ± 3.21 |
The Eyes Test were used to measure cognitive empathy. Higher scores indicate higher cognitive empathy scores. Maximum score is 36, minimum score is 0.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 24.45 | ± 3.88 |
| Control Group | 25.65 | ± 3.27 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 25.39 | ± 4.29 |
| Control Group | 26.59 | ± 3.44 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 130.16 | ± 20.43 |
| Control Group | 119.35 | ± 16.88 |
| Group | Value | 95% CI |
|---|---|---|
| Experimental Group | 126.16 | ± 12.90 |
| Control Group | 117.38 | ± 16.61 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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