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

Primary Purpose

Postpartum Depression, Anxiety, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mothers and Babies (MB)
Sponsored by
Sidra Medical and Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Depression

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 7-12 on the Edinburgh Postpartum Depression Scale (EPDS) and/or 10-15 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 > 15 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    Pregnant women will receive prenatal care as usual.

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    Behavioral Activation
    Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).
    Mood Regulation
    Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro & Means, 1990). For each question, participants will use a 5-point scale to indicate participants' beliefs, or when participants are disappointed or experiencing a negative mood. For the analyses, the study investigators will develop an average to these items to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.
    Social Support
    Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.
    Decentering Thoughts
    Secondary outcome of Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of data analyses, study investigators will create a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.
    Diabetes self-management
    The Diabetes self-care will be assessed using the summary of Diabetes Self-Management questionnaire. The tool contains 16 items, it is a reliable and valid instrument and enables an efficient assessment of self-care behaviors associated with glycemic control. Scale scores were calculated as sums of item scores and then transformed to a scale ranging from 0 to 10 (raw score / theoretical maximum score * 10). A transformed score of ten represents the highest self-rating of the assessed behavior.
    Religious Coping- major life stressors
    The Religious Coping- major life stressors tool is a continuous scale which contains 12 items of religious coping with major life stressors. It has helped contributing to the growth of knowledge about the religion roles that serve in the process of dealing with crisis, trauma, and transition.
    Mothers and Babies Skill Utilization
    The Mothers and Babies Skill Utilization is administered at the 6-month follow-up survey with higher scores indicating greater use of in daily life. The instrument that will be utilized has been developed by the investigators.

    Full Information

    First Posted
    June 18, 2020
    Last Updated
    April 19, 2021
    Sponsor
    Sidra Medical and Research Center
    Collaborators
    Northwestern University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04442529
    Brief Title
    Mothers and Babies Qatar (MB-Q): A Postpartum Depression Intervention
    Acronym
    MB
    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

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2021 (Anticipated)
    Study Completion Date
    October 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sidra Medical and Research Center
    Collaborators
    Northwestern University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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 = 160) 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Depression, Anxiety, Diabetes

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Pregnant women will receive prenatal care as usual.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Pregnant women will receive the 12-session Mothers and Babies intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mothers and Babies (MB)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Depressive symptoms
    Description
    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.
    Time Frame
    Pre-Screening tool
    Title
    Anxiety symptoms
    Description
    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.
    Time Frame
    Pre-Screening tool
    Title
    Perceived stress
    Description
    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.
    Time Frame
    Baseline and six month follow-up
    Secondary Outcome Measure Information:
    Title
    Behavioral Activation
    Description
    Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).
    Time Frame
    Baseline and six month follow-up
    Title
    Mood Regulation
    Description
    Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro & Means, 1990). For each question, participants will use a 5-point scale to indicate participants' beliefs, or when participants are disappointed or experiencing a negative mood. For the analyses, the study investigators will develop an average to these items to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.
    Time Frame
    Baseline and six month follow-up
    Title
    Social Support
    Description
    Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.
    Time Frame
    Baseline and six month follow-up
    Title
    Decentering Thoughts
    Description
    Secondary outcome of Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of data analyses, study investigators will create a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.
    Time Frame
    Baseline and six month follow-up
    Title
    Diabetes self-management
    Description
    The Diabetes self-care will be assessed using the summary of Diabetes Self-Management questionnaire. The tool contains 16 items, it is a reliable and valid instrument and enables an efficient assessment of self-care behaviors associated with glycemic control. Scale scores were calculated as sums of item scores and then transformed to a scale ranging from 0 to 10 (raw score / theoretical maximum score * 10). A transformed score of ten represents the highest self-rating of the assessed behavior.
    Time Frame
    Baseline and six month follow-up
    Title
    Religious Coping- major life stressors
    Description
    The Religious Coping- major life stressors tool is a continuous scale which contains 12 items of religious coping with major life stressors. It has helped contributing to the growth of knowledge about the religion roles that serve in the process of dealing with crisis, trauma, and transition.
    Time Frame
    Baseline and six month follow-up
    Title
    Mothers and Babies Skill Utilization
    Description
    The Mothers and Babies Skill Utilization is administered at the 6-month follow-up survey with higher scores indicating greater use of in daily life. The instrument that will be utilized has been developed by the investigators.
    Time Frame
    Six-month follow-up

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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 7-12 on the Edinburgh Postpartum Depression Scale (EPDS) and/or 10-15 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 > 15 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sawssan Ahmed, PhD
    Phone
    974 4003-6506
    Email
    sahmed2@sidra.org

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The investigators anticipate making the individual participant data available to other researchers who submit a reasonable request to analyze study data.

    Learn more about this trial

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

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