Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women

Abstract

Background Insomnia and sleep disturbances are common in pregnancy and have potentially significant consequences for both maternal and infant health. There is limited research examining the effectiveness of cognitive behavioral therapy for insomnia (CBT-I) during pregnancy. 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. 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). Methods A 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. Five weekly individual sessions of CBT-I will be delivered in person or via telehealth depending on physical distancing guidelines. 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). Discussion CBT-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). 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. 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. Trial registration ClinicalTrials.gov NCT03918057. Registered on 17 April 2019.

Tailoring cognitive behavioural therapy for insomnia across contexts, conditions, and individuals: What do we know, where do we go?

“…Adaptations to standard CBT-I cognitive components have focused on incorporating commonly used cognitive techniques from the treatments of comorbid conditions. Cognitive components have been expanded to address concerns related to the comorbid condition that may interfere with sleep, such as worries about relapse in substance use disorders (Arnedt et al, 2011(Arnedt et al, , 2023, pain catastrophising in fibromyalgia (Martínez et al, 2014), controllable and uncontrollable factors in pregnancy (MacKinnon et al, 2021), unhelpful beliefs about rest versus sleep in traumatic brain injury (Nguyen et al, 2017), coping with daytime fatigue in depression (Carney et al, 2017), and sleepwake state perception in bipolar disorders (Steinan et al, 2014). To address these cognitions, elements from CBT for chronic pain (McCrae et al, 2019;Pigeon et al, 2012;Tang et al, 2020), depression (Scogin et al, 2018), psychosis (Waite et al, 2016), and alcohol and substance use disorders (Arnedt et al, 2023) were provided alongside sleep-focused cognitive therapy.…”

COVID-19–Related Insomnia Populations Research and Management Strategies: A Review

“…During the COVID-19 pandemic, panic, mandatory isolation, unemployment and bankruptcy have had a huge economic, physical and psychological impact on vulnerable populations, and the ensuing anxiety and depression have seriously affected their sleeping conditions. [21][22][23][24] Elderly people are prone to underlying diseases and low immunity. The symptoms of SARS-CoV-2 are complicated and can cause life-threatening conditions in the elderly.…”

“…Vulnerable populations include elderly, kids, disabled persons, adolescents and pregnant women, whose economic conditions are relatively poor, social status is low, and/or social competitiveness is feeble. During the COVID-19 pandemic, panic, mandatory isolation, unemployment and bankruptcy have had a huge economic, physical and psychological impact on vulnerable populations, and the ensuing anxiety and depression have seriously affected their sleeping conditions 21–24 …”

Common Sleep Disorders in Pregnancy

“…There is current research focused on the development of a digital CBT-I program directed to the pregnant population, which may be a promising management option in the future. 76…”