Browsing by Author "MacKinnon, Anna L."
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Item Open Access Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women(2021-08-12) MacKinnon, Anna L.; Madsen, Joshua W.; Dhillon, Ashley; Keys, Elizabeth; Giesbrecht, Gerald F.; Williamson, Tyler; Metcalfe, Amy; Campbell, Tavis; Mrklas, Kelly J.; Tomfohr-Madsen, LianneAbstract 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.Item Open Access The Building Emotional Awareness and Mental health (BEAM) program developed with a community partner for mothers of infants: protocol for a feasibility randomized controlled trial(2023-03-09) Joyce, Kayla M.; Rioux, Charlie; MacKinnon, Anna L.; Katz, Laurence Y.; Reynolds, Kristin; Kelly, Lauren E.; Klassen, Terry; Afifi, Tracie O.; Mushquash, Aislin R.; Clement, Fiona M.; Chartier, Mariette; Xie, Elisabeth B.; Penner, Kailey E.; Hunter, Sandra; Berard, Lindsay; Tomfohr-Madsen, Lianne; Roos, Leslie E.Abstract Background Drastic increases in the rates of maternal depression and anxiety have been reported since the COVID-19 pandemic began. Most programs aim to improve maternal mental health or parenting skills separately, despite it being more effective to target both concurrently. The Building Emotional Awareness and Mental health (BEAM) program was developed to address this gap. BEAM is a mobile health program aiming to mitigate the impacts of pandemic stress on family well-being. Since many family agencies lack infrastructure and personnel to adequately treat maternal mental health concerns, a partnership will occur with Family Dynamics (a local family agency) to address this unmet need. The study’s objective is to examine the feasibility of the BEAM program when delivered with a community partner to inform a larger randomized controlled trial (RCT). Methods A pilot RCT will be conducted with mothers who have depression and/or anxiety with a child 6–18 months old living in Manitoba, Canada. Mothers will be randomized to the 10 weeks of the BEAM program or a standard of care (i.e., MoodMission). Back-end App data (collected via Google Analytics and Firebase) will be used to examine feasibility, engagement, and accessibility of the BEAM program; cost-effectiveness will also be examined. Implementation elements (e.g., maternal depression [Patient Health Questionnaire-9] and anxiety [Generalized Anxiety Disorder-7]) will be piloted to estimate the effect size and variance for future sample size calculations. Discussion In partnership with a local family agency, BEAM holds the potential to promote maternal-child health via a cost-effective and an easily accessible program designed to scale. Results will provide insight into the feasibility of the BEAM program and will inform future RCTs. Trial registration {2a} This trial was retrospectively registered with ClinicalTrial.gov ( NCT05398107 ) on May 31st, 2022.