Perimenstrual Symptoms and Emotional Dysregulation in Autism

NCT06871345 | Not Yet Recruiting

• 2 other identifiers: 94992024-A02269-38
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Autism Spectrum Disorder; Borderline Personality Disorder BPD; a Premenstrual Dysphoric Disorder (PMDD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• Subjective differences in real-life emotional experience between ASD, BPD, PMDD and healthy volunteers

  3 months

• Cognitive correlates of emotional dysregulation by phase of the menstrual cycle

  3 months

Study Arms (4)

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.

Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA)

Autism female patients group

EXPERIMENTAL

20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.

Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA)

Group of female patients with BPD

EXPERIMENTAL

20 female patients with a diagnosis of BPD, according to DSM-5 criteria.

Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA)

Group of female patients with PMDD

OTHER

20 patients with a diagnosis of PMDD, according to DSM-5 criteria

Other: Semi-structured interviews SCID; Other: Self-report questionnaires; Other: Momentary Ecological Assessment (EMA)

Interventions

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".

Autism female patients group; Group of female patients with BPD; Group of female patients with PMDD; Healthy voluntary group

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.

Autism female patients group; Group of female patients with BPD; Group of female patients with PMDD; Healthy voluntary group

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).

Autism female patients group; Group of female patients with BPD; Group of female patients with PMDD; Healthy voluntary group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female patients and female volunteers
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Ecological Momentary Assessment

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Luisa WEINER, Professor

  Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luisa WEINER, Professor

CONTACT

0388116511; luisa.weiner@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04