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

Not Applicable

Completed

• Conditions: Insomnia; Sleep disturbance; Mental Health - Other mental health disorders; Reproductive Health and Childbirth - Childbirth and postnatal care; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001166167
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Study Completion: 2022-03-21
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 127

Inclusion Criteria

(a)Nulliparous mothers in the 3rd trimester of pregnancy (i.e., 26-32 weeks gestation and no older children).
(b)Singleton pregnancy;
(c)Age >= 18 years.
(d)Able to read and write in English.
(e)Have regular access to a smartphone, email, and internet.
(f)Score > 7 on the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).

Exclusion Criteria

(a)Participants who use medications or substance that directly effect sleep (including sleep medications, melatonin, steroid inhalers, antidepressant medications, cannabis, etc.)
(b)Unstable medical conditions that directly affect sleep;
(c)Participants who show the following symptoms of sleep disorders:
a.Sleep apnea: loud snoring OR observed gasping or pauses in breathing OR previously diagnosed with apnea hypopnea index >15 but not/inadequately treated
b.Previously diagnosed Periodic Limb Movement Disorder with arousal index > 15
c.Restless Legs Syndrome (RLS; based on structured interview) occurring greater than or equal to 3 times/week, with duration of at least one month and onset prior to pregnancy. Include even if RLS increased or emerged during pregnancy (as long as pre-pregnancy frequency was no more than once a week before pregnancy and duration criterion was met).
d.Circadian rhythm disorders (based on structured interview):
•Irregular Sleep Wake Disorder
•Non-24-Hour Sleep-Wake Syndrome
•Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8 pm and habitual wake time is earlier than 4 am. Occasional deviation from this schedule is allowed.)
•Delayed Sleep-Phase Syndrome (if habitual bed time is later than 3 am and habitual wake time is later than 11 am. Occasional deviation from this schedule is allowed.)
•Fixed night shift work between midnight and 5 a.m., or rotating work schedules that require night shifts during the course of their pregnancy or during their participation.
•Narcolepsy.
e.Other previously diagnosed sleep disorders – if severe (discuss with PI)
(d)Report severe current psychopathology, including posttraumatic stress disorder, panic disorder (if > 4 nocturnal panic attacks in the past month), substance abuse/dependence disorders; OR life-time bipolar or psychotic disorders; OR having high risk of harm to self or others. Those with current suicidal ideation/self-harm behaviours or those who pose a high risk of harm to others will be excluded and referred to appropriate services.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maternal insomnia symptoms measured via Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001). [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).<br><br>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.]