Perimenstrual Symptoms and Emotional Dysregulation in Autism

Sponsor
University Hospital, Strasbourg, France
Study ID
NCT06871345
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

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".
  • 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.
  • 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).

Study Details

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.

Key Dates

First listed
Mar 11, 2025
Start date
May 1, 2026
Status verified
May 2026
Primary completion
May 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • Experimental: Autism female patients group
    20 female patients with a diagnosis of Autism Spectrum Disorder (ASD), according to DSM-5 criteria.
  • Experimental: Group of female patients with BPD
    20 female patients with a diagnosis of BPD, according to DSM-5 criteria.
  • Other: Group of female patients with PMDD
    20 patients with a diagnosis of PMDD, according to DSM-5 criteria

Primary Outcome Measure

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 [ Time Frame: 3 months ]

Central Contacts

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