Perimenstrual Symptoms and Emotional Dysregulation in Autism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Semi-structured interviews SCID

    Other intervention

    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 intervention

    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 intervention

    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).

Treatment groups

90 Participants
are divided into 4 treatment groups
Group A: Healthy voluntary groupActive comparator 3 interventions
Group B: Autism female patients groupExperimental treatment 3 interventions
Group C: Group of female patients with BPDExperimental treatment 3 interventions
Group D: Group of female patients with PMDDOther 3 interventions

Trial outcomes

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)

Time frame
3 months

Secondary outcomes

1

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)

Time frame
3 months
2

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)

Time frame
3 months
3

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)

Time frame
3 months
4

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

Premenstrual dysphoric symptoms scores

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: