Evaluation of the Links Between Perimenstrual Symptoms and Emotional Dysregulation in Autistic Individuals: Ecological, Subjective, and Cognitive Approach
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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;
研究组 & 干预措施
Group of female patients with PMDD
20 patients with a diagnosis of PMDD, according to DSM-5 criteria
干预措施: Self-report questionnaires (Other)
Autism female patients group
20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.
干预措施: Semi-structured interviews SCID (Other)
Autism female patients group
20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.
干预措施: Self-report questionnaires (Other)
Healthy voluntary group
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.
干预措施: Semi-structured interviews SCID (Other)
Healthy voluntary group
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.
干预措施: Self-report questionnaires (Other)
Healthy voluntary group
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.
干预措施: Momentary Ecological Assessment (EMA) (Other)
Autism female patients group
20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group of female patients with BPD
20 female patients with a diagnosis of BPD, according to DSM-5 criteria.
干预措施: Semi-structured interviews SCID (Other)
Group of female patients with BPD
20 female patients with a diagnosis of BPD, according to DSM-5 criteria.
干预措施: Self-report questionnaires (Other)
Group of female patients with BPD
20 female patients with a diagnosis of BPD, according to DSM-5 criteria.
干预措施: Momentary Ecological Assessment (EMA) (Other)
Group of female patients with PMDD
20 patients with a diagnosis of PMDD, according to DSM-5 criteria
干预措施: Semi-structured interviews SCID (Other)
Group of female patients with PMDD
20 patients with a diagnosis of PMDD, according to DSM-5 criteria
干预措施: Momentary Ecological Assessment (EMA) (Other)
结局指标
主要结局
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
时间窗: 3 months
Comparison between groups (autistic people, people with BPD, people with PMDD, people without disorder) of the intensity of EA assessed using self-questionnaires according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase)
次要结局
- Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers(3 months)
- The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers(3 months)
- The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers(3 months)
- The impact of the menstrual cycle on emotional manifestations(3 months)
- The impact of the menstrual cycle on cognitive manifestations(3 months)
- The impact of the menstrual cycle on behavioral manifestations(3 months)
- Cognitive correlates of emotional dysregulation by phase of the menstrual cycle(3 months)
- Evaluate the intensity of dysphoric symptoms during two menstrual cycles(3 months)
- Understand the impact of these dysphoric symptoms during two menstrual cycles(3 months)
- The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles(3 months)
- The evolution of the emotional experience, assessed in daily life, during two menstrual cycles(3 months)
- The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles(3 months)