Perimenstrual Symptoms and Emotional Dysregulation in Autism (MEDEA)

University Hospital, Strasbourg, France

Status: Not yet enrolling

Conditions: Borderline Personality Disorder BPD; Autism Spectrum Disorder

Treatments: Other: Semi-structured interviews SCID; Other: Cognitive assessment; Other: Momentary Ecological Assessment (EMA); Other: Self-report questionnaires

Study type: Interventional

Funder types: Other

Identifiers

NCT06871345

2024-A02269-38 (Other Identifier)

9499

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

Healthy voluntary group

Active Comparator group

Description:

20 menstruating women with a regular menstrual cycle that lasts between 25 and 35 days, not using hormonal contraception and without a psychiatric and/or neurological diagnosis.

Treatment:

Other: Self-report questionnaires

Other: Momentary Ecological Assessment (EMA)

Other: Cognitive assessment

Other: Semi-structured interviews SCID

Autism female patients group

Experimental group

Description:

20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.

Treatment:

Other: Self-report questionnaires

Other: Momentary Ecological Assessment (EMA)

Other: Cognitive assessment

Other: Semi-structured interviews SCID

Group of female patients with BPD

Experimental group

Description:

20 female patients with a diagnosis of BPD, according to DSM-5 criteria.

Treatment:

Other: Self-report questionnaires

Other: Momentary Ecological Assessment (EMA)

Other: Cognitive assessment

Other: Semi-structured interviews SCID