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Healthier Moms and Babies: Nursing Professor Cynthia Connelly Launches Second Major Perinatal Study

Tuesday, October 22, 2013

The Hahn School of Nursing and Health Science’s first Perinatal Health Study, now in its fifth and final year, has screened over 2,000 poor, educationally, racially, and ethnically diverse pregnant women receiving perinatal care in ten community-based obstetric clinics around San Diego County.

Professor Cynthia D. Connelly, the study’s Principal Investigator, received a $3.1 million dollar grant from the National Institutes for Mental Health to conduct this randomized clinical trial that examined depression and other key variables in women during pregnancy and through their infants’ first year. The research then tested a telehealth intervention to improve depression in the 500 women, 85% of whom were Latina, who met criteria for depression.

The study team found a high incidence of depressive symptomatology, 25 percent, in their screening population. This is of great concern, as are the other serious comorbidities identified in the women. Twenty-three percent identified substance abuse problems, 10% reported exposure to physical abuse –either as direct victims of abuse or by living arrangements in which someone else was abused– and a high incidence of anxiety. Forty-four percent of the women reported significant sleep problems.

Poor and insufficient sleep is an important and too-often neglected aspect of pregnancy. Few mothers are identified or treated for this problem. For the majority of women disruption of sleep is caused by pregnancy-related factors; yet, 29 to 46 percent attribute sleeplessness to other factors.

When nocturnal sleep disturbances are substantiated and associated with clinically significant distress, a diagnosis of “Probable Insomnia Disorder” is warranted. Research findings highlight the deleterious sequelae of perinatal Probable Insomnia Disorder, which include intrauterine growth restriction and preterm delivery.

Little is known about the sleep patterns of Latina women in the United States and even less is known about insomnia among pregnant Latinas. Connelly and her team are not aware of any research on insomnia and its correlates among pregnant Latinas, despite a birth rate approximately 50% higher than among women from other major ethnic groups in the United States. Connelly’s data showed that of 1289 pregnant Latinas (386 in their first trimester [weeks 1-12], 492 in the second trimester [weeks 13-26], and 411 in the third trimester [weeks = 27]), 217 or 16.8% met criteria for Probable Insomnia Disorder based on an Insomnia Severity Index score of 10 or above.

Logistic regression analysis showed depressive symptom level, language in which measures were completed, pregnancy week, marital status, age, household income, and educational level explained 32% of the variance in clinically significant insomnia status. The model correctly classified 96% of those without Probable Insomnia Disorder and 30% of those with Probable Insomnia Disorder. Significant predictors of Probable Insomnia Disorder were higher total scores (excluding the insomnia item) on the Edinburgh Postnatal Depression Scale, completing the measures in English, and lower household income.

Connelly and her study team concluded that insomnia rates among pregnant Latinas are significant, and may be even higher than among non-Latina pregnant women. Rates are particularly high among women with severe depressive symptoms. The possibility that acculturation may uniquely contribute to insomnia among Latina women warrants further study. Future research could determine the unique effects of acculturation, separate from depressive symptoms, and identify specific acculturation factors that may need to be targeted in treatment.

The high levels of insomnia found in the first Perinatal Depression study prompted Connelly to explore possible interventions. Thus, she and Dr. Rachel Manber, a clinical psychologist at Stanford University School of Medicine, are now co-Principal Investigators for a new 5-year $2.7 million multisite randomized clinical trial designed to examine the efficacy and effectiveness of nurse-delivered cognitive behavioral therapy (CBTI) for Maternal Insomnia Disorder. The study also will examine secondary outcomes of maternal and infant sleeping, maternal depressive levels, and quality of life. The USD research team also includes investigators Drs. Karen Macauley and Lois Howland.

This research will test a primary care intervention for Maternal Insomnia Disorder among economically, educationally, racially, and ethnically diverse pregnant women to reduce adverse consequences of poor maternal and reproductive health in minorities and underserved populations.

Maternal Insomnia Disorder, which encompasses insomnia during pregnancy and postpartum, is associated with adverse consequences for the mother and her family. These include increased risk for preterm birth, infants small for gestational age, cesarean birth, poor maternal infant attachment, worsening of the marital relationship, and increased risk for perinatal depression.

Given concerns about taking hypnotics during pregnancy, an accessible and acceptable treatment to improve maternal sleep and mitigate the negative consequences of poor sleep on the mother and the infant is highly significant.

Cognitive Behavioral Therapy for Insomnia (CBTI) is an effective treatment that has demonstrated improvement equivalent to that of hypnotic medications; and its effects are more durable than medication after treatment is discontinued. The weight of evidence supporting CBTI, summarized in several meta-analyses, led to its recognition as a first-line treatment for insomnia by the National Institutes of Health Consensus Statement and the British Association of Psychopharmacology.

Even when factors outside of an individual’s control interfere with sleep, CBTI can lead to significant improvement as shown by: evidence that CBTI leads to significant reductions in time awake at night and insomnia severity when Insomnia Disorder is comorbid with medical conditions, such as chronic pain and cancer, which disrupt sleep; and recent evidence that CBTI is effective for postpartum insomnia, despite sleep disruption caused by the need to attend to an infant.

One reason CBTI is effective, even when sleep is disrupted by factors not in one’s control, it increases the sleep drive, extinguishes conditioned arousal, and focuses on altering the maladaptive behaviors and cognitions that patients adopt in their efforts to improve their sleep at bedtime or after waking up in the night.

Connelly, Manbar, Howland, and Macauley will be the first to test the efficacy of CBTI in treating Maternal Insomnia Disorder. Six studies have documented the efficacy of CBTI for insomnia when delivered in primary care settings but no study has been conducted in an obstetric clinic.

Several features of the current investigation will facilitate engagement in treatment and maximize acceptance and accessibility. A large proportion of the target population consists of low income women.

Therefore, the method of service delivery will be flexible (in the obstetric clinic or by telephone); sessions will be shorter than traditional CBTI to allow integration into busy obstetrical clinics; and therapy will be provided by nurses to minimize stigma.

Nurses will be trained using Standardized Patients in USD’s Simulation and Standardized Patient Nursing Lab and competency will be determined using a CBTI Competency Rating Scale. A novel aspect of the CBTI is the use of two nurse-administered educational interventions (TIPS-Tips for Infant and Parent Sleep).

– Barbara Davenport

This story first appeared in the Fall 2013 USD Nursing Times magazine.

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