Treat insomnia pregnancy trial#

Since being declared a global pandemic on Ma, the outbreak of coronavirus disease 2019 (COVID-19) and the related public health measures put in place to limit its spread (i.e., physical and social distancing) have been associated with significantly increased distress and mental health concerns, particularly among pregnant women. Meta-analyses suggest that the prevalence of poor sleep quality and clinically significant insomnia during pregnancy ranges from 20 to 60%, depending on trimester and method of assessment. Insomnia and poor sleep quality-defined as difficulty initiating or maintaining sleep, restriction in hours of sleep, or feeling that sleep is unrefreshing-is common in pregnancy. This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Treat insomnia pregnancy trial#

Name and contact information for the trial sponsor ĭepartment of Psychology, University of CalgaryĢ500 University Drive NW, Calgary, Alberta, T2N 1N4 Lianne Tomfohr-Madsen, University of Calgary Gerald F. Giesbrecht, University of Calgary This work was supported by an Early Career Investigator operating grant in Maternal, Reproductive, Child & Youth Health from the Canadian Institutes of Health Research (LTM).Įlizabeth Keys, University of British Columbia, Okanagan Campus The trial was registered with (NCT03918057) on April 17, 2019. Sleeping for Two: study protocol for a randomized controlled trial of cognitive behavioural therapy for insomnia in pregnant women Findings will enhance understanding of pregnancy-related sleep problems, as well as means by which to improve the health and sleep of mothers and their children. This RCT builds on a successful open pilot trial conducted by our team and will provide further evaluation of a novel evidence-based treatment for pregnancy-related insomnia, which can be widely disseminated and used to treat individuals that are most in need of intervention.

DiscussionĬBT-I delivered in pregnancy has the potential to reduce symptoms of insomnia and depression and could lead to reduced risk of preterm birth, all of which can minimize risk of negative maternal and child health and developmental consequences in the short (e.g., infant death) and long terms (e.g., developmental delays). Assessment of insomnia diagnosis by structured interview, self-reported insomnia symptom severity and sleep problems, and sleep quantity and quality as measured by a daily diary and actigraphy will occur at 12–28 weeks of pregnancy (T1), 1 week post-treatment (T2), and 6 months postpartum (T3). Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. MethodsĪ two-arm, single-blinded, parallel group randomized controlled trial (RCT) design with repeated measures will be used to evaluate the impact of CBT-I compared to TAU among a sample of 62 pregnant women, enrolled between 12 and 28 weeks of gestation, who self-identify as experiencing insomnia. The aims of this trial are to evaluate the impact of the Sleeping for Two adaptation of CBT-I in pregnancy (in-person or telehealth) versus treatment as usual (TAU) in reducing symptoms of insomnia (primary outcome), as well as increasing gestational length and reducing symptoms of depression (secondary outcomes). With increased distress and limited access to services during the COVID-19 pandemic, there is also an unprecedented need for telehealth delivery of treatment programs for pregnant women. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health.