Perimenstrual Symptoms and Emotional Dysregulation in Autism
NCT ID: NCT06871345
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
70 participants
INTERVENTIONAL
2025-03-01
2028-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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".
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.
Cognitive assessment
Cognitive assessment, coupled with the recording of physiological parameters (Biopac).
Participants will complete a battery of neuropsychological tests targeting emotional processes. These tests will make it possible to evaluate the hot component of executive functioning, i.e. specifically involved in the processing of socio-emotional information. Autobiographical verbal fluences and the emotional Hayling test will be used to measure initiation and inhibition processes, respectively.
Momentary Ecological Assessment (EMA)
A momentary ecological evaluation protocol will be proposed between visits V1 and V4 in order to assess the emotional and symptomatic dynamics in a context of daily life. During two menstrual cycles, subjects will be invited, via their smartphone, to take daily semi-random readings (indicated by SMS) of their subjective (4 times/day), but also spontaneous emotional experiences
Autism female patients group
20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.
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".
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.
Cognitive assessment
Cognitive assessment, coupled with the recording of physiological parameters (Biopac).
Participants will complete a battery of neuropsychological tests targeting emotional processes. These tests will make it possible to evaluate the hot component of executive functioning, i.e. specifically involved in the processing of socio-emotional information. Autobiographical verbal fluences and the emotional Hayling test will be used to measure initiation and inhibition processes, respectively.
Momentary Ecological Assessment (EMA)
A momentary ecological evaluation protocol will be proposed between visits V1 and V4 in order to assess the emotional and symptomatic dynamics in a context of daily life. During two menstrual cycles, subjects will be invited, via their smartphone, to take daily semi-random readings (indicated by SMS) of their subjective (4 times/day), but also spontaneous emotional experiences
Group of female patients with BPD
20 female patients with a diagnosis of BPD, according to DSM-5 criteria.
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".
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.
Cognitive assessment
Cognitive assessment, coupled with the recording of physiological parameters (Biopac).
Participants will complete a battery of neuropsychological tests targeting emotional processes. These tests will make it possible to evaluate the hot component of executive functioning, i.e. specifically involved in the processing of socio-emotional information. Autobiographical verbal fluences and the emotional Hayling test will be used to measure initiation and inhibition processes, respectively.
Momentary Ecological Assessment (EMA)
A momentary ecological evaluation protocol will be proposed between visits V1 and V4 in order to assess the emotional and symptomatic dynamics in a context of daily life. During two menstrual cycles, subjects will be invited, via their smartphone, to take daily semi-random readings (indicated by SMS) of their subjective (4 times/day), but also spontaneous emotional experiences
Interventions
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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".
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.
Cognitive assessment
Cognitive assessment, coupled with the recording of physiological parameters (Biopac).
Participants will complete a battery of neuropsychological tests targeting emotional processes. These tests will make it possible to evaluate the hot component of executive functioning, i.e. specifically involved in the processing of socio-emotional information. Autobiographical verbal fluences and the emotional Hayling test will be used to measure initiation and inhibition processes, respectively.
Momentary Ecological Assessment (EMA)
A momentary ecological evaluation protocol will be proposed between visits V1 and V4 in order to assess the emotional and symptomatic dynamics in a context of daily life. During two menstrual cycles, subjects will be invited, via their smartphone, to take daily semi-random readings (indicated by SMS) of their subjective (4 times/day), but also spontaneous emotional experiences
Eligibility Criteria
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Inclusion Criteria
* 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 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
* 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 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).
* Woman with a psychiatric, neurodevelopmental or neurological history;
* Woman on psychotropic therapy or treatment that modifies physiological parameters (e.g., beta-blockers).
18 Years
45 Years
FEMALE
Yes
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Luisa WEINER, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg
Central Contacts
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Other Identifiers
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2024-A02269-38
Identifier Type: OTHER
Identifier Source: secondary_id
9499
Identifier Type: -
Identifier Source: org_study_id
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