None listed
Conditions
Brief summary
Symptoms of insomnia are common for women in the perinatal period. A primary precipitating factor for postpartum insomnia is infant nocturnal awakenings. As women cope with these significant sleep disruptions, they may also develop unhelpful sleep-related cognitions/behaviours, which can perpetuate sleep problems well into the postpartum period. Therefore, (a) infant sleep as a precipitator, and (b) maternal sleep-related cognitions and behaviours as perpetuators are sound therapeutic targets for reducing and preventing insomnia in perinatal women. The primary aim (Aim 1) is to examine whether reducing exposure to a major precipitator of postpartum insomnia by increasing infant sleep continuity and duration from 0-6 months, lowers symptoms of postpartum insomnia in first-time mothers who are at risk for insomnia. It is predicted that compared to controls, women receiving the infant sleep intervention will report better sleep and wellbeing. The secondary aim (Aim 2) is exploratory. It examines how two interventions, one addressing infant sleep, the other targeting maternal sleep-related cognition/behaviours, might ameliorate the development of postpartum insomnia. Participants, 114 mother-and-infant dyads recruited during pregnancy (N = 228), will be randomised into 1 of 3 conditions: (a) an infant sleep intervention, (b) a maternal sleep intervention, and (c) a control condition. Infant sleep intervention participants will receive a bassinet that uses noise and ‘rocking’ motions to boost infant sleep. The maternal sleep intervention is based on Cognitive Behavioural Therapy for Insomnia (CBT-I), and is delivered at 6 stages: 30 and 35 weeks pregnancy, then 2 weeks, 2 months, 3 months, and 6 months postpartum. The control group will receive sleep information at 26-32 weeks pregnancy. Outcome measures of sleep and wellbeing will be collected at 30 and 35 weeks pregnancy, and 2, 6, and 12 months postpartum.
Interventions
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: Partic
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).
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Outcome results
None listed