Perimenstrual Symptoms and Emotional Dysregulation in Autism (MEDEA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder; Borderline Personality Disorder BPD; a Premenstrual Dysphoric Disorder (PMDD)
• Intervention / Treatment: Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA)

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Luisa WEINER, Professor; Phone Number: 0388116511; Email: luisa.weiner@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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".; Other: 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.; Other: 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).
Experimental: Autism female patients group; 20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.	Other: 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".; Other: 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.; Other: 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).
Experimental: Group of female patients with BPD; 20 female patients with a diagnosis of BPD, according to DSM-5 criteria.	Other: 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".; Other: 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.; Other: 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).
Other: Group of female patients with PMDD; 20 patients with a diagnosis of PMDD, according to DSM-5 criteria	Other: 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".; Other: 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.; Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Luisa WEINER, Professor, Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder; Behavioral Disciplines and Activities; Psychological Tests; Ecological Momentary Assessment
• Other Study ID Numbers: 9499; 2024-A02269-38 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No