Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention (NCT04442529) | Clinical Trial Compass
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Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention
Qatar120 participantsStarted 2021-05-01
Plain-language summary
Qatar Mothers and Babies is a 4-year collaboration between Northwestern University Feinberg School of Medicine and Sidra Medicine in Doha, Qatar that will generate and evaluate a cultural and contextual adaptation of the Mothers and Babies intervention for pregnant Arabic-speaking women in Qatar. The study will examine the feasibility and acceptability of the adapted intervention as well as its effectiveness in improving mental health outcomes among pregnant women receiving prenatal care at Sidra Medicine in Doha. Additionally, given the high prevalence of diabetes among this study population, the investigators are also interested in seeing if the Mothers and Babies interventions helps improve the management of this disease. Funded by the Qatar National Research Fund's National Priorities Research Program (NPRP), this project has the potential to guide future cultural adaptations of Mothers and Babies as well as other evidence-based interventions, and the delivery of Mothers and Babies to Arab and Arab-American women.
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria are identical for the pilot study and RCT.
* Participants must be 18 years of age or older
* Participants should speak Arabic fluently
* Participants must be up to 28 + 0 weeks pregnant
* Participants should not be diagnosed with a fetal anomaly that is incompatible with life or whose anomalies will have significant physical or developmental morbidity
* Participants should not be currently receiving treatment for mental health difficulties,
* Participants should not have a history of a serious mental health condition and,
* Participants must screen between 6-12 on the Edinburgh Postpartum Depression Scale (EPDS) and/or 5-14 on the Generalized Anxiety and Depression Scale (GAD-7).
Exclusion criteria:
* Participants who do not meet these screening criteria but are experiencing mild to moderate symptoms of depression will be provided mental health resources including a link to the Mothers \& Babies website with English and Arabic manuals for self-directed study.
* Screened women scoring \> 14 on the GAD-7 and/or \>12 on the EPDS and/or those currently receiving mental health treatment will be offered a referral to Sidra's Women's Mental Health Clinic for further evaluation and treatment, as needed.
* Anyone who endorses the suicidality question ideation (EPDS #10) will be offered same day review by a Sidra women's mental health clinician, who will ascertain the level of risk and offer assistance as clinically indicated.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.