Clinical trial NCT06871345: Perimenstrual Symptoms and Emotional Dysregulation in Autism
Official title: Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic People: Ecological, Subjective, Cognitive and Physiological Approach.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Borderline Personality Disorder BPD
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion criteria:

Common Inclusion Criteria for Healthy Patients and Volunteers:

* Female aged 18 to 45;
* Woman with regular menstrual cycles (variations in duration, measured between the shortest menstrual cycle) and the longest cycle, remain strictly less than 7 days) between 25 and 35 days;
* Woman without hormonal contraception (or NON-hormonal copper IUD) or who has stopped contraception for more than 3 months (and does not wish to take it again);
* Woman with a smartphone with an internet connection;
* Woman able to understand the objectives and risks of the research and to give informed, dated and signed consent;
* Woman affiliated to a social protection health insurance scheme, beneficiary or beneficiary.

Patient-specific inclusion criteria:

* Patient with a diagnosis of Autism Spectrum Disorder without intellectual disability (ASD), according to the criteria of the DSM-5 OR
* Patient with a diagnosis of BPD, according to DSM-5 criteria

Exclusion criteria:

Non-inclusion criteria common to healthy patients and volunteers:

* Taking hormonal treatment or synthetic steroids;
* Woman using hormonal contraceptives (pill, patch, hormonal IUD, vaginal ring, implant, intramuscular injection);
* Pregnancy or breastfeeding on the declaration of the person for less than 3 months;
* Desire to become pregnant within 3 months of inclusion;
* Endocrinopathies (in particular clinical signs of hyperandrogenism) or untreated gynaecological pathologies that may influence menstrual cycles and/or ovulation;
* Participation in another study that may interfere with the study;
* Inability to give the person informed information (person in an emergency or life-threatening situation);
* Woman under judicial protection;
* Woman under guardianship or curatorship;
* Woman hospitalized for a period \> 24 hours

Patient-specific non-inclusion criteria:

* Patient with a diagnosis of psychotic disorder;
* Patient with a diagnosis of severe substance use disorder, i.e., presence of 6 or more symptoms;
* Patient with a diagnosis of bipolar disorder type I or II or cyclothymia;
* Patient with a diagnosis of co-occurring ASD and BPD;
* Patient with an intellectual disability (IQ ≤ 70);
* Patient with neurological comorbidity (e.g., acquired brain injury);
* Patient on treatment that alters physiological response (heart rhythm, e.g., beta-blockers).

Non-inclusion criteria specific to healthy volunteers:

* Woman with a psychiatric, neurodevelopmental or neurological history;
* Woman on psychotropic therapy or treatment that modifies physiological parameters (e.g., beta-blockers).

Primary outcomes:
measure: The links between emotional dysregulation and premenstrual dysphoric symptoms in autistic women compared to women with borderline personality disorder and women without a diagnosed psychiatric disorder (healthy volunteers).
timeFrame: 3 months
Secondary outcomes:
measure: The impact of the menstrual cycle on emotional manifestations
timeFrame: 3 months
measure: The impact of the menstrual cycle on cognitive manifestations
timeFrame: 3 months
measure: The impact of the menstrual cycle on behavioral manifestations
timeFrame: 3 months
measure: Subjective differences in real-life emotional experience between ASD, BPD, and healthy volunteers
timeFrame: 3 months
measure: Cognitive correlates of emotional dysregulation by phase of the menstrual cycle
timeFrame: 3 months
measure: The concordance between subjective, physiological and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD and healthy volunteers
timeFrame: 3 months
measure: The concordance between cognitive and physiological measures of emotional dysregulation, assessed in consultation, in autistic people compared to people with BPD and healthy volunteers
timeFrame: 3 months
measure: The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD and healthy volunteers
timeFrame: 3 months
measure: Evaluate the intensity of dysphoric symptoms during two menstrual cycles
timeFrame: 3 months
measure: Understand the impact of these dysphoric symptoms during two menstrual cycles
timeFrame: 3 months
measure: The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles
timeFrame: 3 months
measure: The evolution of the emotional experience, assessed in daily life, during two menstrual cycles
timeFrame: 3 months
measure: The evolution of physiological emotional responses, assessed in daily life and in consultation, during two menstrual cycles
timeFrame: 3 months
measure: The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles
timeFrame: 3 months
measure: The concordance between cognitive and physiological measures of emotional dysregulation, assessed in consultation, in autistic people compared to people with BPD and healthy volunteers
timeFrame: 3 months
measure: The concordance between cognitive and physiological measures of emotional dysregulation, assessed in consultation, in autistic people compared to people with BPD and healthy volunteers
timeFrame: 3 months
measure: The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD and healthy volunteers
timeFrame: 3 months
measure: The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD and healthy volunteers
timeFrame: 3 months
measure: The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles
timeFrame: 3 months
measure: The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
name: Luisa WEINER, Professor
role: PRINCIPAL_INVESTIGATOR
References: