The Study for Mother-Infant Sleep (The SMILE Project): Reducing postpartum insomnia in first-time mothers.

Intervention

Intervention code Behaviour , Treatment: Devices

A provisional psychologist trained in the study protocol under the supervision of a clinical psychologist, will interact with participants in the three intervention conditions via phone to personalise interventions, providing recommendations of certain modules through an orientation phone call which will take up to 90 minutes. Participants will be randomised into 1 of 3 conditions: (a) an infant sleep intervention, (b) a maternal sleep intervention, and (c) a control condition. Group A: Particip .... A provisional psychologist trained in the study protocol under the supervision of a clinical psychologist, will interact with participants in the three intervention conditions via phone to personalise interventions, providing recommendations of certain modules through an orientation phone call which will take up to 90 minutes. Participants will be randomised into 1 of 3 conditions: (a) an infant sleep intervention, (b) a maternal sleep intervention, and (c) a control condition. Group A: Participants in the infant sleep intervention condition will be asked to use a responsive bassinet from birth until their infant reaches 6 months postpartum. The bassinet (a) automatically emits white-noise sounds, (b) safely swaddles the infant, which is recommended by the American Academy of Pediatrics (APP) as the safest sleeping position for the prevention of Sudden Infant Death Syndrome, and (c) provides rhythmic ‘rocking’ motions when crying noises are detected. Importantly, the bassinet employs these strategies for a maximum of 3 minutes. If the infant does not settle within this time, the bassinet alerts adults for additional assistance via a mobile application (e.g., feeding, changing). Use of the responsive bassinet and mobile application will be measured using an Intervention Adherence and Usefulness questionnaire delivered at 8 weeks and 6 months postpartum to examine roles in treatment response. Bassinet status/usage data will also be collected using the mobile application. Group B: The maternal sleep condition uses therapist-assisted self-help cognitive behavioural therapy for insomnia (CBT-I) to address maladaptive sleep-related cognitions and behaviours. Content of the intervention is delivered via the following three means, combined: (1) A 50-minute telephone session conducted by a provisional psychologist; (2) A series of emails containing text, graphics, and/or audio-based intervention components are delivered at 6 stages: 30 weeks and 35 weeks pregnancy, then 2 weeks, 2 months, 3 months, and 6 months postpartum. Each email will address a specific component of sleep disturbance relevant to women in the perinatal period (e.g. developing healthy sleep habits) via text and images, and may include links to audio-based mindfulness and relaxation exercises. All participants in Group B will receive the same emails, which have been specifically designed for this study. (3) Mothers who have difficulty applying the intervention materials can request brief email or telephone clarification from the provisional psychologist who conducted the initial session. Treatment adherence will be measured using an Intervention Adherence and Usefulness questionnaire delivered at 35-36 weeks of gestation, and 8 weeks and 6 months postpartum. Treatment effects will be assessed at 5 time points: 26-32 weeks of gestation (T1), 35-36 weeks of gestation (T2), 8 weeks postpartum (T3), 6 months postpartum (T4), and 12 months postpartum (T5).
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Comparison

Control group Active

Group C: Participants in the control condition will receive an information booklet at 30 weeks pregnancy containing the psychoeducation and sleep hygiene information from the maternal sleep intervention without other components. The information booklet has been designed specifically for this study. This condition will account for the non-specific effects of attention and participation in a sleep program (e.g., contact with health professionals, receiving health information, and expectations of b .... Group C: Participants in the control condition will receive an information booklet at 30 weeks pregnancy containing the psychoeducation and sleep hygiene information from the maternal sleep intervention without other components. The information booklet has been designed specifically for this study. This condition will account for the non-specific effects of attention and participation in a sleep program (e.g., contact with health professionals, receiving health information, and expectations of benefit).
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Outcomes

Outcome: Maternal insomnia symptoms measured via Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).
Timepoint: The ISI will be assessed at 5 time points: 26-32 weeks of gestation (T1), 35-36 weeks of gestation (T2), 8 weeks postpartum (T3), 6 months postpartum (T4), and 12 months postpartum (T5). The average ISI across T3-T5 will be used as the primary timepoint, as well as postpartum endpoint. As shown in previous data, sleep undergoes major changes during .... Outcome: Maternal insomnia symptoms measured via Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).
Timepoint: The ISI will be assessed at 5 time points: 26-32 weeks of gestation (T1), 35-36 weeks of gestation (T2), 8 weeks postpartum (T3), 6 months postpartum (T4), and 12 months postpartum (T5). The average ISI across T3-T5 will be used as the primary timepoint, as well as postpartum endpoint. As shown in previous data, sleep undergoes major changes during the postpartum period, and ISI scores across multiple time points estimate cumulative, total symptom burden. We will also examine group differences at T2 as the pregnancy endpoint.
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