The primary objective is to explore phenotypes of (sub)clinical PMDD and explore the impact of (sub)clinical PMDD on the lives of the affected women.The secondary objective is to assess the validity of a Dutch translation of the self-administered C-…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
- Gender related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is PMM/PMDD symptomatology as assessed using the
C-PASS questionnaire.
Secondary outcome
Secondary parameters are clinical diagnosis (SCID in validation study only),
PMDD symptoms, co-morbid somatic and mental symptoms (GRSR, EPDS, PANAS, PQ-16,
BSI-18, ADHD-screener, ASSIST-Lite), personality (DAPP-sf, HSP), quality of
life (Q-LES-Q-SF), days of sick leave, disease course, medication use, service
use, wellbeing, social functioning, psychiatric symptoms and history.
Background summary
Premenstrual disorders (PMDs), including premenstrual syndrome and premenstrual
dysphoric disorder, (PMDD) affect millions of women of reproductive age with a
significant health impact. Research into aetiology, phenotyping, and treatment
of PMDs is hampered by the absence of validated measures and the reliance on
retrospective data. Prospective cohorts with valid measures on PMDs are
urgently needed. PMDs in general, and PMDD (Premenstrual Mood Dysphoric
Disorder) in particular are largely absent from Dutch research. We aim to
describe phenotypes of (sub)clinical PMDD and explore the impact of
(sub)clinical PMDD on the lives of the affected women.
Study objective
The primary objective is to explore phenotypes of (sub)clinical PMDD and
explore the impact of (sub)clinical PMDD on the lives of the affected women.
The secondary objective is to assess the validity of a Dutch translation of the
self-administered C-PASS questionnaire in detecting patients diagnosed with
PMDD.
Study design
This study will be a prospective observational cohort study using a convenience
sample of women, self-diagnosed as suffering from premenstrual syndrome (PMS)
or premenstrual dysphoric disorder (PMDD). The aim of the study is to describe
phenotypes of (sub)clinical PMDD and to explore the impact of these symptoms on
the lives of the affected women. Secondly, we aim to study the validity of the
Dutch translation of the C-PASS as a diagnostic instrument to screen for PMDD.
Premenstrual symptoms will be assessed over a period of three menstrual cycles.
The participants are women suffering from (self) diagnosed PMS or PMDD. The
participants will be recruited through the social media channels of the
patient*s grassroots organization (Stichting PMDD NL). The participants will be
enrolled after they are checked for the in- and exclusion criteria and have
signed the informed consent form (IC). After signing informed consent, they
will be interviewed by a trained interviewer on hormonal cycle, hormonal and
mental health symptoms, illness and treatment history and family history of
hormonal disorders and mental illness. A series of fully structured symptom
questionnaires will be administered through the use of a datacapture system
(CASTOR). Depending on the nature of the symptoms, these will be administered
monthly, bi-weekly (in luteal and follicular phase), or daily.
A selection of the participants will be invited to participate in a study to
validate the C-PASS screening interview. For this study, stricter in- and
exclusion criteria apply. Enrollment will take place after informed consent has
been signed. For this study, participants will be interviewed using the SCID
interview to establish a clinical diagnosis of PMDD according to DSM-TR
criteria, as well as fill in the C-PASS on a daily basis over a three month
period.
The study is non-invasive and all questionnaires can be administered online.
Study burden and risks
In this research, we study a population of women with self-reported clinical
and subclinical premenstrual symptoms. However, these women are not part of a
clinical population: the subjects will be recruited through the patient
association, and will consist of a mix of women with self-reported clinical and
subclinical premenstrual complaints.
By participating in this study, women do not receive a direct benefit. They do
benefit from their symptoms being heard and talked about, since this population
is usually undiagnosed. Peer-support is also available and beneficial to women
who may need this. Participants will need to fill in different questionnaires
at various time points in this study, which can be filled in at home. The
design of the study is non-therapeutic. The risks of participation are close to
zero. No risks are known for self-report questionnaires.
The only minor risk for participating in this study is reporting about
childhood trauma through the childhood trauma questionnaire. This
questionnaire will be administered once, at the beginning of the study
There will be a few minor burdens for participating in this study, which
includes amongst
others: an interview by a trained interviewer about women*s hormonal cycle,
hormonal and mental health symptoms, illness and treatment history, and family
history of hormonal disorders and mental illness at inclusion (30 min) and a
semi-structured clinical interview SCID interview (30 min). Furthermore. the
C-PASS and sleep-related questionnaire may form a burden. Participants will
administer these daily for 3 months.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
For the observational prospective cohort study women must meet the following
criteria:
All participants must give signed informed consent.
All participants must be of fertile age (16 years of age or older, with a
maximum of 60 years).
Participants must experience self-reported PMS or PMDD related symptoms.
Participants must have a detectable cycle, which may either be a natural
menstrual cycle or induced by hormonal contraceptives, of no longer than 40
days.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from the observational prospective cohort study:
Current pregnancy, or actively trying to conceive
Insufficient proficiency in Dutch
A potential subject who meets any of the following criteria will be excluded
from the validation study:
Current pregnancy, or actively trying to conceive
Insufficient proficiency in Dutch
Any current DSM-5 Axis 1 clinical disorder (other than PMDD) according to the
SCID interview
Current use of psychopharmaceutical medication
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL83427.078.23 |