Perimenstrual Symptoms and Emotional Dysregulation in Autism

Официальное название

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

Обзор

Emotional dysregulation (ED) is defined by difficulties in modulating the experience and expression of emotions, which are characterized by particularly marked reactivity, intensity, and duration. 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, known adversities during childhood, and premenstrual dysphoric symptoms. This study aims to characterize the variability of ED throughout a menstrual cycle by measuring it in an ecological real-life context. The variability of ED will be compared to that of women with borderline personality disorder (BPD), women with premenstrual dysphoric disorder (PMDD), and women without a diagnosed disorder.

Вмешательства

• Другое 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".
• Другое 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.
• Другое Momentary Ecological Assessment (EMA)
  A momentary ecological assessment protocol will be proposed between the inclusion visit and the end-of-protocol visit in order to evaluate emotional and symptomatic dynamics in a daily life context. For two menstrual cycles, subjects will be invited, via their smartphone, to make daily recordings (prompted by SMS) of their subjective emotional experiences (3 times/day).

Первичные конечные точки

• The links between emotional dysregulation and premenstrual dysphoric symptoms in autistic women compared to women with borderline personality disorder, women with premenstrual dysphoric disorder compared to women without a diagnosed psychiatr [Срок оценки: 3 months]

Вторичные конечные точки (12)

• The impact of the menstrual cycle on emotional manifestations [Срок оценки: 3 months]
• The impact of the menstrual cycle on cognitive manifestations [Срок оценки: 3 months]
• The impact of the menstrual cycle on behavioral manifestations [Срок оценки: 3 months]
• Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers [Срок оценки: 3 months]
• Cognitive correlates of emotional dysregulation by phase of the menstrual cycle [Срок оценки: 3 months]
• The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers [Срок оценки: 3 months]
• Evaluate the intensity of dysphoric symptoms during two menstrual cycles [Срок оценки: 3 months]
• Understand the impact of these dysphoric symptoms during two menstrual cycles [Срок оценки: 3 months]
• The evolution of the emotional experience, assessed in daily life, during two menstrual cycles [Срок оценки: 3 months]
• The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles [Срок оценки: 3 months]
• The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers [Срок оценки: 3 months]
• The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles [Срок оценки: 3 months]

Критерии участия

Критерии включения

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:

• Specific inclusion criteria for female patients
• Patient with a diagnosis of Autism Spectrum Disorder without intellectual disability (ASD), according to DSM-5 criteria OR
• Patient with a diagnosis of BPD, according to DSM-5 criteria OR
• Patient meeting the diagnostic criteria for PMDD with the SCID

Критерии исключения

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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06871345 · 9499 · 2024-A02269-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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