Psychiatric ProblemNCT04792671
Prevalence and Risk Factors of Women Mental Health Disorders
An observational study of Psychiatric Problem and Wolman Disease, run by Assiut University.
Trial summary
Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Problem, Wolman Disease
- What is being tested?
- Sociodemographic variables, Family affluence scale (FAS) and Edinburgh postnatal depression scale (EPDS)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This is study will take part in the Assiut government primary health centres in community
Who may be able to join
- age 18 years -50 years.
- No previous history of psychiatric, neurological or medical disease
Who cannot join
- intelligence equation less than 80
- have history of psychiatric, neurological or medical disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prevalence and Risk Factors of Women Mental Health Disorders in Assiut Governorate
Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome.
So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it
- Conditions
- Psychiatric Problem, Wolman Disease
- Being tested
- Sociodemographic variables, Family affluence scale (FAS), Edinburgh postnatal depression scale (EPDS), Symptom Checklist 90 "SCL 90":
- Keywords
- women, mental health
- Medical subject headings
- Wolman Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sociodemographic variablesBehavioural
age, residence, education of the mother and her husband, occupation of the mother and her husband, parity, gender, and age of the last baby.
Family affluence scale (FAS)Behavioural
a four-item measure of family wealth, has been developed in the WHO Health Behaviour in School-aged Children Study as an alternative measure.
Edinburgh postnatal depression scale (EPDS)Behavioural
s a questionnaire originally developed to assist in identifying possible symptoms of depression in the postnatal period. It also has adequate sensitivity and specificity to identify depressive symptoms in the antenatal period and is useful in identifying symptoms of anxiety. more than 9 is clinically diagnosed
Symptom Checklist 90 "SCL 90":Behavioural
is a 90-item questionnaire used to assess psychological problems. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. More than 60 is considered clinically diagnosed
| Study group | Role | What they receive |
|---|---|---|
| Perinatal group | females who are pregnancy Receives: Behavioral: Sociodemographic variables; Behavioral: Family affluence scale (FAS); Behavioral: Edinburgh postnatal depression scale (EPDS); Behavioral: Symptom Checklist 90 "SCL 90": | |
| postpartum group | female who get delivery(from day 1 up to 1 year) Receives: Behavioral: Sociodemographic variables; Behavioral: Family affluence scale (FAS); Behavioral: Edinburgh postnatal depression scale (EPDS); Behavioral: Symptom Checklist 90 "SCL 90": |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal
Measured: through study completion, an average of 1 year
measure of risk factor of DSM 5 psychiatric disorders in perinatal and postnatal
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Mar 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Psychiatric ProblemStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gellan Karamalllah Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792671
- Sponsor's protocol ID
- women mental health disorders
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sambrook Smith M, Lawrence V, Sadler E, Easter A. Barriers to accessing mental health services for women with perinatal mental illness: systematic review and meta-synthesis of qualitative studies in the UK. BMJ Open. 2019 Jan 24;9(1):e024803. doi: 10.1136/bmjopen-2018-024803.
PubMed 30679296Sheffield KM, Woods-Giscombe CL. Efficacy, Feasibility, and Acceptability of Perinatal Yoga on Women's Mental Health and Well-Being: A Systematic Literature Review. J Holist Nurs. 2016 Mar;34(1):64-79. doi: 10.1177/0898010115577976. Epub 2015 Apr 20.
PubMed 25896571Sharma V, Burt VK. DSM-V: modifying the postpartum-onset specifier to include hypomania. Arch Womens Ment Health. 2011 Feb;14(1):67-9. doi: 10.1007/s00737-010-0182-2. Epub 2010 Sep 25.
PubMed 20872155
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Women Mental Health Disorders in Assiut Governorate
- ClinicalTrials.gov ID
- NCT04792671
- Acronym / sponsor ID
- women mental health disorders
- Conditions
- Psychiatric Problem, Wolman Disease
- Keywords
- women, mental health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Perinatal major depressive disorder affects 20% of women, while perinatal anxiety affects 10% of women. Although pharmacological treatment has shown effectiveness, many pregnant women are concerned about potential adverse effects on the fetus, maternal-infant bonding, and child development.. On the other hand, Depressive disorder in women mainly occurs during the first year after childbirth. It takes many forms according to the onset, severity, and duration of the symptoms including; Postpartum blues (PPB), Postpartum depression (PPD), and Postpartum psychosis (PPP). Lack of access to mental health services during the perinatal period is a significant public health concern that may worse outcome.
So, we aimed to study prevalence of women mental health in Assiut governorate and evaluate possible risk factor for it
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal group | – | Behavioral: Sociodemographic variables, Behavioral: Family affluence scale (FAS), Behavioral: Edinburgh postnatal depression scale (EPDS), Behavioral: Symptom Checklist 90 "SCL 90":females who are pregnancy |
| postpartum group | – | Behavioral: Sociodemographic variables, Behavioral: Family affluence scale (FAS), Behavioral: Edinburgh postnatal depression scale (EPDS), Behavioral: Symptom Checklist 90 "SCL 90":female who get delivery(from day 1 up to 1 year) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is study will take part in the Assiut government primary health centres in community
Key inclusion criteria (2 listed)
- age 18 years -50 years.
- No previous history of psychiatric, neurological or medical disease
Key exclusion criteria (2 listed)
- intelligence equation less than 80
- have history of psychiatric, neurological or medical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sociodemographic variablesage, residence, education of the mother and her husband, occupation of the mother and her husband, parity, gender, and age of the last baby. | Behavioural | Perinatal group, postpartum group |
| Family affluence scale (FAS)a four-item measure of family wealth, has been developed in the WHO Health Behaviour in School-aged Children Study as an alternative measure. | Behavioural | Perinatal group, postpartum group |
| Edinburgh postnatal depression scale (EPDS)s a questionnaire originally developed to assist in identifying possible symptoms of depression in the postnatal period. It also has adequate sensitivity and specificity to identify depressive symptoms in the antenatal period and is useful in identifying symptoms of anxiety. more than 9 is clinically diagnosed | Behavioural | Perinatal group, postpartum group |
| Symptom Checklist 90 "SCL 90":is a 90-item questionnaire used to assess psychological problems. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. More than 60 is considered clinically diagnosed | Behavioural | Perinatal group, postpartum group |
Primary outcome
measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal
Time frame: through study completion, an average of 1 year
measure of risk factor of DSM 5 psychiatric disorders in perinatal and postnatal
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Background: PubMed 30679296Sambrook Smith M, Lawrence V, Sadler E, Easter A. Barriers to accessing mental health services for women with perinatal mental illness: systematic review and meta-synthesis of qualitative studies in the UK. BMJ Open. 2019 Jan 24;9(1):e024803. doi: 10.1136/bmjopen-2018-024803.
- Results publication: PubMed 25896571Sheffield KM, Woods-Giscombe CL. Efficacy, Feasibility, and Acceptability of Perinatal Yoga on Women's Mental Health and Well-Being: A Systematic Literature Review. J Holist Nurs. 2016 Mar;34(1):64-79. doi: 10.1177/0898010115577976. Epub 2015 Apr 20.
- Results publication: PubMed 20872155Sharma V, Burt VK. DSM-V: modifying the postpartum-onset specifier to include hypomania. Arch Womens Ment Health. 2011 Feb;14(1):67-9. doi: 10.1007/s00737-010-0182-2. Epub 2010 Sep 25.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Problem and Wolman Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact gellan Ahmed (+201093663928, gillankaram@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure the prevalence of DSM 5 psychiatric disorders in perinatal and postnatal (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04792671, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.