Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention

NCT04442529 | Recruiting

• 1 other identifier: 2019-0004
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression; Anxiety; Diabetes

Outcome Measures

Primary Outcomes (3)

• Depressive symptoms

  First primary outcome of depressive symptoms is the Edinburgh Postpartum Depression Scale (EPDS). Scores are determined by participant self-report on screening questions. The total can range from 0 to 30 with higher scores indicating greater depressive symptoms.

  Pre-Screening tool

• Anxiety symptoms

  Second primary outcome of anxiety symptoms is the Generalized Anxiety Disorder 7-Item Scale (GAD-7). Scores are determined by participant self-report on screening questions. The GAD-7 total score can range from 0-21 with higher scores indicating more anxiety symptoms.

  Pre-Screening tool

• Perceived stress

  Third primary outcome of perceived stress is the Perceived Stress Scale 10-item version (PSS-10). Scores are determined by participant self-report at baseline and six-month follow-up. Scores range from 0-40 with higher scores indicate greater perceived stress.

  Baseline and six month follow-up

Secondary Outcomes (7)

• Behavioral Activation

  Baseline and six month follow-up

• Mood Regulation

  Baseline and six month follow-up

• Social Support

  Baseline and six month follow-up

• Decentering Thoughts

  Baseline and six month follow-up

• Diabetes self-management

  Baseline and six month follow-up

Study Arms (2)

Control

NO INTERVENTION

Pregnant women will receive prenatal care as usual.

Intervention

EXPERIMENTAL

Pregnant women will receive the 12-session Mothers and Babies intervention

Behavioral: Mothers and Babies (MB)

Interventions

Mothers and Babies (MB) BEHAVIORAL

Mothers and Babies is an evidence-based postpartum depression prevention intervention. It consists of 12 sessions which each last between 15-20 minutes. Intervention sessions are to be delivered either in person or by phone. The intervention is based on principles of cognitive-behavioral therapy (CBT).

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidra Medicine: lead
• Northwestern University: collaborator

Study Sites (1)

Sidra

Doha, 26999, Qatar

RECRUITING

Related Publications (1)

• Ahmed SR, Watt F, Mahfoud ZR, Korayem M, Buhmaid S, Alberry M, Ibrahim IM, Tandon SD. Examining Feasibility, Acceptability, and Preliminary Outcomes of a Culturally Adapted Evidence-Based Postpartum Depression Preventive Intervention for Women in Doha, Qatar: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Aug 11;12:e11623. doi: 10.2196/11623.

  PMID: 37566449 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Sawssan Ahmed, PhD

CONTACT

974 4003-6506; sahmed2@sidra.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: May 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Locations

QA (1)