Mindfulness for African Americans Postpartum

NCT05280938 | Completed DMC

• 2 other identifiers: 212354K23NR019101
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized clinical trial (RCT) design will be used to compare an 8-week Mindfulness for African Americans Postpartum (MAAP) intervention to an 8-week Educational Program (active comparison group). The primary objective is to evaluate the effectiveness of MAAP to decrease maternal psycho-behavioral symptoms and to improve mother/infant bonding. To better meet the needs of new mothers, MAAP will use a online form of delivery (i.e., group synchronous virtual Zoom). A secondary objective is to explore proinflammatory cytokines and oxytocin as possible biological mechanisms by which the MAAP intervention might decrease psycho-behavioral symptoms and improve mother/infant bonding. The MAAP intervention includes best approach and is culturally adapted based on prior evidence and expert opinion, and it addresses weaknesses in rigor of prior studies.

Conditions

Mental Disorders of Mother, Postpartum

Outcome Measures

Primary Outcomes (21)

• Parental Stress Level

  Stress is this proposal specifically measures how a participant feels regarding her infant. Stress will be measured with the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). PSS: NICU has good construct validity and uses 28 items, rated on a 5-point Likert scale. Maternal perceived stress is measured using 3 sub-scales: 1) Stress experienced by parents from appearance, 2) behavior of their child, 3) the NICU environment affecting parenting role. Cronbach's alphas for the sub-scales are reported to be .80-.87, and the Cronbach's alpha is .88 for the total scale. This instrument is specifically tailored to parents with infants in the NICU and questions include: How stressful it is to see your infant with tubes or other devices, How stressful it is to witness your infant's behavior such as breathing difficulty, and How stressful it is to be a parent and not able to fully are for your infant.

  Baseline (week 1)

• Parental Stress Level

  Stress is this proposal specifically measures how a participant feels regarding her infant. Stress will be measured with the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). PSS: NICU has good construct validity and uses 28 items, rated on a 5-point Likert scale. Maternal perceived stress is measured using 3 sub-scales: 1) Stress experienced by parents from appearance, 2) behavior of their child, 3) the NICU environment affecting parenting role. Cronbach's alphas for the sub-scales are reported to be .80-.87, and the Cronbach's alpha is .88 for the total scale. This instrument is specifically tailored to parents with infants in the NICU and questions include: How stressful it is to see your infant with tubes or other devices, How stressful it is to witness your infant's behavior such as breathing difficulty, and How stressful it is to be a parent and not able to fully are for your infant.

  mid treatment (week 4)

• Parental Stress Level

  Stress is this proposal specifically measures how a participant feels regarding her infant. Stress will be measured with the Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU). PSS: NICU has good construct validity and uses 28 items, rated on a 5-point Likert scale. Maternal perceived stress is measured using 3 sub-scales: 1) Stress experienced by parents from appearance, 2) behavior of their child, 3) the NICU environment affecting parenting role. Cronbach's alphas for the sub-scales are reported to be .80-.87, and the Cronbach's alpha is .88 for the total scale. This instrument is specifically tailored to parents with infants in the NICU and questions include: How stressful it is to see your infant with tubes or other devices, How stressful it is to witness your infant's behavior such as breathing difficulty, and How stressful it is to be a parent and not able to fully are for your infant.

  end of treatment (week 8)

• Depressive Symptoms

  Depressive symptoms include feelings of sadness and loss of interest and can affect sleep, eating, anxiety, trouble concentrating, self-blame, and unexplained physical discomfort. These symptoms can cause difficulty with day to day activities including difficulty with maternal interactions with her infant and daily infant care. Postpartum depressive symptoms are depressive symptoms occurring during the postpartum time which has been defined as up to 4 weeks postpartum ranging to up to one year postpartum. Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression Scale (CESD). The CESD is a self-report measure consisting of 20 depressive symptoms items and rated on a 4-point Likert Scale. Scores range from 0-60. Higher scores indicate more depressive symptoms. Scores \>15 indicate elevated depressive symptoms. Cronbach's alpha = .87-91 in minority mothers of preterm infants.

  Baseline (week 1)

• Depressive Symptoms

  Depressive symptoms include feelings of sadness and loss of interest and can affect sleep, eating, anxiety, trouble concentrating, self-blame, and unexplained physical discomfort. These symptoms can cause difficulty with day to day activities including difficulty with maternal interactions with her infant and daily infant care. Postpartum depressive symptoms are depressive symptoms occurring during the postpartum time which has been defined as up to 4 weeks postpartum ranging to up to one year postpartum. Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression Scale (CESD). The CESD is a self-report measure consisting of 20 depressive symptoms items and rated on a 4-point Likert Scale. Scores range from 0-60. Higher scores indicate more depressive symptoms. Scores \>15 indicate elevated depressive symptoms. Cronbach's alpha = .87-91 in minority mothers of preterm infants.

  mid treatment (week 4)

• Depressive Symptoms

  Depressive symptoms include feelings of sadness and loss of interest and can affect sleep, eating, anxiety, trouble concentrating, self-blame, and unexplained physical discomfort. These symptoms can cause difficulty with day to day activities including difficulty with maternal interactions with her infant and daily infant care. Postpartum depressive symptoms are depressive symptoms occurring during the postpartum time which has been defined as up to 4 weeks postpartum ranging to up to one year postpartum. Depressive symptoms will be measured with the Center for Epidemiologic Studies Depression Scale (CESD). The CESD is a self-report measure consisting of 20 depressive symptoms items and rated on a 4-point Likert Scale. Scores range from 0-60. Higher scores indicate more depressive symptoms. Scores \>15 indicate elevated depressive symptoms. Cronbach's alpha = .87-91 in minority mothers of preterm infants.

  end of treatment (week 8)

• Anxiety Level

  Anxiety includes feelings of worry, nervousness, fear, unease, or excess uncertainty. State anxiety is a transient reaction directly related to an adverse situation and will be measured in this proposal. Maternal state anxiety will be measured with the state anxiety sub-scale of the State-Trait Anxiety Inventory (STAI). The state sub-scale consists of 20 items rated on a 4-point Likert scale and includes topics such as the degree to which the mother currently feels happy, calm, comfortable, jittery, upset, and confused. A higher score is associated with higher levels of anxiety. Cronbach's alphas .85-.95. Numerous reliability and validity studies of the STAI have been conducted with coefficients ranging from .16-.53, as would be expected, as the STAI is designed to be influenced by situational factors.

  Baseline (week 1)

• Anxiety Level

  Anxiety includes feelings of worry, nervousness, fear, unease, or excess uncertainty. State anxiety is a transient reaction directly related to an adverse situation and will be measured in this proposal. Maternal state anxiety will be measured with the state anxiety sub-scale of the State-Trait Anxiety Inventory (STAI). The state sub-scale consists of 20 items rated on a 4-point Likert scale and includes topics such as the degree to which the mother currently feels happy, calm, comfortable, jittery, upset, and confused. A higher score is associated with higher levels of anxiety. Cronbach's alphas .85-.95. Numerous reliability and validity studies of the STAI have been conducted with coefficients ranging from .16-.53, as would be expected, as the STAI is designed to be influenced by situational factors.

  mid treatment (week 4)

• Anxiety Level

  Anxiety includes feelings of worry, nervousness, fear, unease, or excess uncertainty. State anxiety is a transient reaction directly related to an adverse situation and will be measured in this proposal. Maternal state anxiety will be measured with the state anxiety sub-scale of the State-Trait Anxiety Inventory (STAI). The state sub-scale consists of 20 items rated on a 4-point Likert scale and includes topics such as the degree to which the mother currently feels happy, calm, comfortable, jittery, upset, and confused. A higher score is associated with higher levels of anxiety. Cronbach's alphas .85-.95. Numerous reliability and validity studies of the STAI have been conducted with coefficients ranging from .16-.53, as would be expected, as the STAI is designed to be influenced by situational factors.

  end of treatment (week 8)

• Elevated Posttraumatic stress

  Postpartum post-traumatic stress is a type of stress affecting persons exposed to traumatic events. Elevated post-traumatic stress symptoms include 1) re-experiencing the event through thoughts, 2) avoidance of stimuli related to the event, and 3) increased arousal since the event. Post-traumatic stress symptoms after childbirth may be related to a traumatic childbirth experience or to a previous traumatic event in the mother's life. The Perinatal PTSD Questionnaire (PPQ) will measure the extent to which mothers experience post-traumatic stress symptoms in response to their birth experience. PPQ has 14 yes-no items that measure intrusive thoughts (e.g., bad dreams of giving birth), avoidance or numbing (e.g., inability to remember parts of the hospitalization), and increased arousal (e.g., increased irritability or anger). The "yes" answers are summed. Cronbach's alpha was .83 and test-retest reliability from 2 to 4 weeks was .92

  Baseline (week 1)

• Elevated Posttraumatic stress

  Postpartum post-traumatic stress is a type of stress affecting persons exposed to traumatic events. Elevated post-traumatic stress symptoms include 1) re-experiencing the event through thoughts, 2) avoidance of stimuli related to the event, and 3) increased arousal since the event. Post-traumatic stress symptoms after childbirth may be related to a traumatic childbirth experience or to a previous traumatic event in the mother's life. The Perinatal PTSD Questionnaire (PPQ) will measure the extent to which mothers experience post-traumatic stress symptoms in response to their birth experience. PPQ has 14 yes-no items that measure intrusive thoughts (e.g., bad dreams of giving birth), avoidance or numbing (e.g., inability to remember parts of the hospitalization), and increased arousal (e.g., increased irritability or anger). The "yes" answers are summed. Cronbach's alpha was .83 and test-retest reliability from 2 to 4 weeks was .92

  mid treatment (week 4)

• Elevated Posttraumatic stress

  Postpartum post-traumatic stress is a type of stress affecting persons exposed to traumatic events. Elevated post-traumatic stress symptoms include 1) re-experiencing the event through thoughts, 2) avoidance of stimuli related to the event, and 3) increased arousal since the event. Post-traumatic stress symptoms after childbirth may be related to a traumatic childbirth experience or to a previous traumatic event in the mother's life. The Perinatal PTSD Questionnaire (PPQ) will measure the extent to which mothers experience post-traumatic stress symptoms in response to their birth experience. PPQ has 14 yes-no items that measure intrusive thoughts (e.g., bad dreams of giving birth), avoidance or numbing (e.g., inability to remember parts of the hospitalization), and increased arousal (e.g., increased irritability or anger). The "yes" answers are summed. Cronbach's alpha was .83 and test-retest reliability from 2 to 4 weeks was .92

  end of treatment (week 8)

• Sleep Quality

  Sleep disturbance includes difficulties falling asleep, staying asleep, and contributes to disease, impaired cognition, and poor quality of life. Sleep disturbances have been reported by many postpartum women and are associate with psycho-behavioral disturbances such as depressive symptoms. Maternal sleep quality will be measured by the Pittsburgh Sleep Quality Inventory (PSQI). The PSQI is a 19 question self-rated questionnaire which assesses sleep quality, has a global score of 0-21, and has 7 sub-scales. Higher scores indicate worse sleep quality. A PSQI score \>5 yielded a sensitivity of 89.6% and a specificity of 86.5% in distinguishing good and poor sleepers. Internal consistency is .76-.83 and in perinatal women Cronbach's alpha ranges are .72-.78.

  Baseline (week 1)

• Sleep Quality

  Sleep disturbance includes difficulties falling asleep, staying asleep, and contributes to disease, impaired cognition, and poor quality of life. Sleep disturbances have been reported by many postpartum women and are associate with psycho-behavioral disturbances such as depressive symptoms. Maternal sleep quality will be measured by the Pittsburgh Sleep Quality Inventory (PSQI). The PSQI is a 19 question self-rated questionnaire which assesses sleep quality, has a global score of 0-21, and has 7 sub-scales. Higher scores indicate worse sleep quality. A PSQI score \>5 yielded a sensitivity of 89.6% and a specificity of 86.5% in distinguishing good and poor sleepers. Internal consistency is .76-.83 and in perinatal women Cronbach's alpha ranges are .72-.78.

  mid treatment (week 4)

• Sleep Quality

  Sleep disturbance includes difficulties falling asleep, staying asleep, and contributes to disease, impaired cognition, and poor quality of life. Sleep disturbances have been reported by many postpartum women and are associate with psycho-behavioral disturbances such as depressive symptoms. Maternal sleep quality will be measured by the Pittsburgh Sleep Quality Inventory (PSQI). The PSQI is a 19 question self-rated questionnaire which assesses sleep quality, has a global score of 0-21, and has 7 sub-scales. Higher scores indicate worse sleep quality. A PSQI score \>5 yielded a sensitivity of 89.6% and a specificity of 86.5% in distinguishing good and poor sleepers. Internal consistency is .76-.83 and in perinatal women Cronbach's alpha ranges are .72-.78.

  end of treatment (week 8)

• Fatigue Symptoms

  Fatigue is extreme tiredness resulting from mental or physical exertion. Symptoms of fatigue include tiredness, headache, aching/sore muscles, impaired decision-making and judgement, moodiness, and irritability. Fatigue has been reported in many postpartum women and is associate with psycho-behavioral disturbances. Maternal fatigue will be measured by the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF). MFSI-SF is a 14 item self-report instrument that measure severity, frequency, and patterns of fatigue. The MFSI provides a score for overall fatigue in 5 domains (general, emotional, physical, mental, vigor). Factor analysis shows good fit and internal consistency ranges from .87-.96

  Baseline (week 1)

• Fatigue Symptoms

  Fatigue is extreme tiredness resulting from mental or physical exertion. Symptoms of fatigue include tiredness, headache, aching/sore muscles, impaired decision-making and judgement, moodiness, and irritability. Fatigue has been reported in many postpartum women and is associate with psycho-behavioral disturbances. Maternal fatigue will be measured by the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF). MFSI-SF is a 14 item self-report instrument that measure severity, frequency, and patterns of fatigue. The MFSI provides a score for overall fatigue in 5 domains (general, emotional, physical, mental, vigor). Factor analysis shows good fit and internal consistency ranges from .87-.96

  mid treatment (week 4)

• Fatigue Symptoms

  Fatigue is extreme tiredness resulting from mental or physical exertion. Symptoms of fatigue include tiredness, headache, aching/sore muscles, impaired decision-making and judgement, moodiness, and irritability. Fatigue has been reported in many postpartum women and is associate with psycho-behavioral disturbances. Maternal fatigue will be measured by the Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF). MFSI-SF is a 14 item self-report instrument that measure severity, frequency, and patterns of fatigue. The MFSI provides a score for overall fatigue in 5 domains (general, emotional, physical, mental, vigor). Factor analysis shows good fit and internal consistency ranges from .87-.96

  end of treatment (week 8)

• Mindfulness

  Mindfulness is a mental state of focusing one's awareness on the present moment, acknowledging/accepting one's mental feelings, physical feelings, and thoughts. The Five Facets of Mindfulness Questionnaire (FFMQ) will be used to assess mindfulness. These facets include: observing,describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. The FFMQ utility with African American samples is established with an internal consistency range of .60-.86

  Baseline (week 1)

• Mindfulness

  Mindfulness is a mental state of focusing one's awareness on the present moment, acknowledging/accepting one's mental feelings, physical feelings, and thoughts. The Five Facets of Mindfulness Questionnaire (FFMQ) will be used to assess mindfulness. These facets include: observing,describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. The FFMQ utility with African American samples is established with an internal consistency range of .60-.86

  mid treatment (week 4)

• Mindfulness

  Mindfulness is a mental state of focusing one's awareness on the present moment, acknowledging/accepting one's mental feelings, physical feelings, and thoughts. The Five Facets of Mindfulness Questionnaire (FFMQ) will be used to assess mindfulness. These facets include: observing,describing, acting with awareness, non-judging of inner experience, non-reactivity to inner experience. The FFMQ utility with African American samples is established with an internal consistency range of .60-.86

  end of treatment (week 8)

Secondary Outcomes (6)

• Pro-inflammatory cytokines

  Baseline (week 1)

• Pro-inflammatory cytokines

  mid treatment (week 4)

• Pro-inflammatory cytokines

  end of treatment (week 8)

• oxytocin

  Baseline (week 1)

• oxytocin

  mid treatment (week 4)

Study Arms (2)

MAAP Intervention

EXPERIMENTAL

The MAAP intervention is an 8-week adapted mindfulness intervention based upon Kabat-Zinn's MBSR. The intervention includes spirituality, self-empowerment, interdependence, and story-telling which are salient to AAW. Session topics include Tasting Your Life, Seeing and Believing, The Scent of Roses, When Life Hurts, Hearing Your Own Cries, Embracing Inner Peace, Holding on, Welcoming Stillness. Each session will include an introduction, opening mindfulness practice, class responses to the previous week, review guidelines for class, guided individual reflection, group go-around/discussion, yoga, abdominal breathing, body scan, conclusion, and home practice. Face to face sessions 1, 4, 8 will be in a quiet room to allow group sitting or free floor space. Sessions 2, 3, 5, 6, are virtual on the zoom app. Participants receive practice links and a program workbook. Program attendance, type/amount of practice (weekly logs), and changes in mindfulness will be included in data analysis.

Behavioral: MAAP

Educational Program

ACTIVE COMPARATOR

The Education Program (attention control group) will be an 8-week educational program matched in duration and frequency to the MAAP intervention. Session topics are:1) Perineum and Incision Care, 2) Safe Sexual Practices, 3) Understanding Infant Feeding Methods, 4) How to Communicate Effectively with your Child's Health Care Providers, 5) Healthy Eating, 6) Infant Changing and Baths, 7) Infant Safety at Home, and 8) Utilizing Support from Family and the Community. Sessions will be given in groups by the same expert clinicians/educators for all cohorts. Subject receipt of the attention control will be monitored by attendance. Control group instructor will not include content on stress reduction or methods (yoga, meditation, etc.) taught in the MAAPI intervention. Classes will be given in the same setting as the MAAPI intervention, at the same time but on a different evening, to avoid crossover of effects.

Behavioral: Educational Program

Interventions

MAAP BEHAVIORAL

Women randomized to the MAAP intervention will complete an 8 week (2hr/wk) hybrid adapted Kabat-Zinn's MBSR.(Kabat-Zinn, 1990) MAAP intervention includes activities related to spirituality, self-empowerment, interdependence, and story-telling, which are salient to AAW.(Watson-Singleton et al., 2019) Women will receive practice links and a program work book (5th grade level) containing objectives and weekly MAAP activities/. Individual weekly home practice is expected. Type and minutes of home practice will be recorded in weekly logs. Program attendance, type, amount of practice, and changes in mindfulness (Five Facet Mindfulness Questionnaire) will be included in data analysis.

MAAP Intervention

Educational Program BEHAVIORAL

The 8-week Educational Program will be matched in duration, frequency, delivery method, and data collection to the MAAP intervention. Like MAAP, it will be delivered using a hybrid format (virtual Zoom and in person visits). Sessions will be given in groups by an expert perinatal clinician/educator for all cohorts. Content will be "set" and delivered consistently across cohorts. Sessions will be audiotaped and rated for achievement of objectives and consistency of delivery. Deviations will be promptly addressed. Subject receipt will be monitored by attendance. Sessions will not include content on stress reduction (yoga, meditation, etc.). Classes will be given in the same setting as the MAAP intervention, at the same time but on a different evening, to avoid crossover (diffusion) of effects.

Educational Program

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria.
• Participants must identify as African American/Black and have given birth to an infant
• Participants will be over the age of 18 and able to speak and read English at a 5th grade level or above.
• Participants must be willing to comply with study procedures including completion of an 8-week intervention or educational program, provide saliva samples 3 times at session 1, 4, and 8, answer questionnaires concerning demographics, and psycho-behavioral health symptoms, and be available for in person and virtual sessions during the duration of the study.
• Participants must be willing to adhere to the MAAP intervention.
• Participants must have access to a smart phone and agree to download the free app Zoom
• Participants must sign and date an informed consent document -

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation:
• Participants will be excluded from the study if they are currently using immune medications such as steroids, whether prescribed or not
• Participants are excluded from the study if they have a diagnosis or disease process (physical or psychological) that precludes participation in the MAAP intervention.

Sponsors & Collaborators

• Loyola University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 15, 2022
• Study Start: February 7, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)