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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02269-38 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy voluntary group | Active Comparator | 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. |
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| Autism female patients group | Experimental | 20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria. |
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| Group of female patients with BPD | Experimental | 20 female patients with a diagnosis of BPD, according to DSM-5 criteria. |
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| Group of female patients with PMDD | Other | 20 patients with a diagnosis of PMDD, according to DSM-5 criteria |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interviews SCID | Other | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of the menstrual cycle on emotional manifestations | Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP) | 3 months |
| The impact of the menstrual cycle on cognitive manifestations |
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Inclusion criteria:
Common Inclusion Criteria for Healthy Patients and Volunteers:
Patient-specific inclusion criteria:
Exclusion criteria:
Non-inclusion criteria common to healthy patients and volunteers:
Patient-specific non-inclusion criteria:
Non-inclusion criteria specific to healthy volunteers:
- Woman with a psychiatric, neurodevelopmental, or neurological history;
Female patients and female volunteers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luisa WEINER, Professor | Contact | 0388116511 | luisa.weiner@chru-strasbourg.fr |
| Name | Affiliation | Role |
|---|---|---|
| Luisa WEINER, Professor | Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg | Principal Investigator |
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|
| Self-report questionnaires | Other | Participants will complete a battery of self-report questionnaires, assessing emotional dysregulation (including SRD, the primary endpoint), childhood adversity, anxiety, depression, and premenstrual symptoms. |
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| Momentary Ecological Assessment (EMA) | Other | 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). |
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Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP) |
| 3 months |
| The impact of the menstrual cycle on behavioral manifestations | Correlation and mediation between scores on scales regarding emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), childhood adversities (CTQ), and premenstrual dysphoric symptoms (PSST, DRSP) | 3 months |
| Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers | Premenstrual dysphoric symptoms scores | 3 months |
| Cognitive correlates of emotional dysregulation by phase of the menstrual cycle | Comparison of scores obtained on scales assessing emotional dysregulation (DERS-16, BEDS, TAS-20, FREE), borderline traits (BSL-23), autistic traits (AQ), anxious traits (EDAS-21), and depressive traits (EDAS-21, BDI) in the follicular phase and in the late luteal phase of the menstrual cycle; | 3 months |
| The concordance between subjective and cognitive measures of emotional dysregulation, assessed in daily life, in ASD, BPD, PMDD and healthy volunteers | Comparison of the frequency, intensity, and variability of emotional responses recorded in real-life contexts (ecological momentary assessment - EMA) according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase) | 3 months |
| Evaluate the intensity of dysphoric symptoms during two menstrual cycles | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | 3 months |
| Understand the impact of these dysphoric symptoms during two menstrual cycles | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | 3 months |
| The evolution of the emotional experience, assessed in daily life, during two menstrual cycles | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | 3 months |
| The evolution of cognitive functioning underlying emotional dysregulation, over the course of two menstrual cycles | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | 3 months |
| The association between subjective and cognitive measures of emotional dysregulation, assessed in consultation, in ASD compared to BPD, PMDD, and healthy volunteers | Comparison of performance on the emotional Stroop task proposed in daily life according to the phase of the menstrual cycle (follicular phase, luteal phase, and late luteal phase); | 3 months |
| The evolution of self-reported emotional dysregulation assessed in daily life during two menstrual cycles | Comparison of all these assessments between the groups (autistic women, women with borderline personality disorder, women with PMDD, and control group). | 3 months |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000072860 | Ecological Momentary Assessment |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
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