Clinical trial NCT04442529: Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention
Official title: Qatar Mothers and Babies: Examining the Feasibility, Acceptability, and Preliminary Outcomes Associated With Integrating a Postpartum Depression Intervention Into Perinatal Services for Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Anxiety
Diabetes
Lead sponsor: Sidra Medicine
Sponsor class: OTHER
Collaborators: name: Northwestern University
First posted: 2020-06-22
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Postpartum depression and anxiety are the two most common perinatal mental health disorders (mental health disorders occurring during pregnancy and the year after birth), with prevalence rates higher among women living in Qatar than in most western countries. The negative outcomes associated with postpartum depression and anxiety are profound, and include poor birth outcomes, poor parenting practices, and compromised infant and young child development. Although interventions exist to prevent postpartum depression and anxiety, to date there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic speaking women in the Middle East, including Qatar. This project brings together a multidisciplinary team of researchers and clinicians from Sidra Medicine (Qatar) and Northwestern University Feinberg School of Medicine (USA) to conduct a first-of-its-kind study that examines the feasibility, acceptability, and outcomes associated with an evidence-based postpartum depression intervention-Mothers and Babies (MB). MB has been widely used in the USA and has been linguistically translated into Arabic and successfully delivered to Arab-American women. In Phase One of this project, the investigators will culturally and contextually adapt Mothers and Babies to ensure its suitability for use with women residing in Qatar. In Phase Two, the investigators will conduct a small pilot study that examines the acceptability, appropriateness, and feasibility of the adapted Mothers and Babies intervention. Specifically, the investigators will deliver the adapted intervention to 10 women receiving prenatal care at Sidra Medicine. In Phase Three, the investigators will conduct a randomized controlled trial (n = 210) to determine the effectiveness of the adapted Mothers and Babies intervention on depressive symptoms, anxiety symptoms, and perceived stress among women receiving prenatal care at Sidra Medicine. As part of the randomized controlled trial, the investigators will recruit a sub-group of 40 women with diabetes, given the high prevalence of diabetes among women in Qatar and the negative outcomes associated with diabetes on mother and child. The investigators will explore whether the cognitive-behavioral techniques in Mothers and Babies are effective not only in promoting better mental health outcomes among this subgroup, but also better diabetes self-management.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptoms
timeFrame: Pre-Screening tool
measure: Anxiety symptoms
timeFrame: Pre-Screening tool
measure: Perceived stress
timeFrame: Baseline and six month follow-up
Secondary outcomes:
measure: Behavioral Activation
timeFrame: Baseline and six month follow-up
measure: Mood Regulation
timeFrame: Baseline and six month follow-up
measure: Social Support
timeFrame: Baseline and six month follow-up
measure: Decentering Thoughts
timeFrame: Baseline and six month follow-up
measure: Diabetes self-management
timeFrame: Baseline and six month follow-up
measure: Religious Coping- major life stressors
timeFrame: Baseline and six month follow-up
measure: Mothers and Babies Skill Utilization
timeFrame: Six-month follow-up
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Sidra
Study officials:
References: