NCT06871345

Perimenstrual Symptoms and Emotional Dysregulation in Autism

Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic People: Ecological, Subjective, Cognitive and Physiological Approach.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Strasbourg, France · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Emotional dysregulation (ED) is defined as difficulties in modulating the experience and expression of emotions, which are characterized by a particularly marked reactivity, intensity and duration. In order to improve the understanding of ED, its consequences in autistic women, and to be able to offer them appropriate treatments, it seems crucial to investigate the links between ED, adversities experienced during childhood and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED along a menstrual cycle by measuring it in a real-life ecological context. The variability of ED will be compared to that of women with borderline personality disorder BPD and that of women without psychiatric disorders.

Conditions

• Autism Spectrum Disorder
• Borderline Personality Disorder BPD

Interventions

Type	Name	Description
OTHER	Semi-structured interviews SCID	Structured Clinical Interview for DSM-5 Personality Disorder (SCID) : The SCID is a 90-item semi-structured interview, covering all 10 categories of personality disorder as described in the DSM-5. Each item is rated on a three-point scale: "absent", "subclinical level" and "present".
OTHER	Self-report questionnaires	Participants will complete a battery of self-report questionnaires, assessing emotional dysregulation (including SRD, the primary endpoint), childhood adversity, anxiety, depression, and premenstrual symptoms.
OTHER	Cognitive assessment	Cognitive assessment, coupled with the recording of physiological parameters (Biopac). Participants will complete a battery of neuropsychological tests targeting emotional processes. These tests will make it possible to evaluate the hot component of executive functioning, i.e. specifically involved in the processing of socio-emotional information. Autobiographical verbal fluences and the emotional Hayling test will be used to measure initiation and inhibition processes, respectively.
OTHER	Momentary Ecological Assessment (EMA)	A momentary ecological evaluation protocol will be proposed between visits V1 and V4 in order to assess the emotional and symptomatic dynamics in a context of daily life. During two menstrual cycles, subjects will be invited, via their smartphone, to take daily semi-random readings (indicated by SMS) of their subjective (4 times/day), but also spontaneous emotional experiences

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-03-01
• Completion: 2028-09-01
• First posted: 2025-03-11
• Last updated: 2025-03-11