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Perimenstrual Symptoms and Emotional Dysregulation in Autism

NCT06871345 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    lead OTHER

Principal Investigators

  • Luisa WEINER, Professor · Department of Psychiatry II Psychiatry, Mental Health and Addiction Medicine, University Hospitals of Strasbourg

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-05-01
Completion
2029-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06871345 on ClinicalTrials.gov