Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001166167
Ethics application status
Approved
Date submitted
6/08/2019
Date registered
20/08/2019
Date last updated
13/05/2022
Date data sharing statement initially provided
20/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Study for Mother-Infant Sleep (The SMILE Project): Reducing postpartum insomnia in first-time mothers.
Scientific title
The Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers.
Secondary ID [1] 298681 0
None
Universal Trial Number (UTN)
Trial acronym
SMILE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 313575 0
Sleep disturbance 313576 0
Condition category
Condition code
Mental Health 312008 312008 0 0
Other mental health disorders
Reproductive Health and Childbirth 312009 312009 0 0
Childbirth and postnatal care
Neurological 312420 312420 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 314948 0
Treatment: Devices
Intervention code [2] 314949 0
Behaviour
Comparator / control treatment
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).
Control group
Active

Outcomes
Primary outcome [1] 320652 0
Maternal insomnia symptoms measured via Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).
Timepoint [1] 320652 0
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.
Secondary outcome [1] 372334 0
Maternal sleep quality measured using the PROMIS Sleep Disturbance (Buysse et al., 2010).
Timepoint [1] 372334 0
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).
Secondary outcome [2] 372335 0
Maternal sleep-related impairment, measured using the PROMIS Sleep Related Impairment (Buysse et al., 2010).
Timepoint [2] 372335 0
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).
Secondary outcome [3] 372336 0
Mother-infant relationship measured using Mother to Infant Bonding Scale (MIBS; Taylor, Atkins, Kumar, Adams, & Glover, 2005).
Timepoint [3] 372336 0
Assessed at 8 weeks postpartum (T3), 6 months postpartum (T4), and 12 months postpartum (T5).
Secondary outcome [4] 372337 0
Maternal depressive symptoms measured with PROMIS Depression (Pilkonis et al., 2011)
Timepoint [4] 372337 0
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).
Secondary outcome [5] 372338 0
Relationship satisfaction, using the brief Dyadic Adjustment Scale (Sabourin, Valois, & Lussier, 2005) for mothers who have a partner.
Timepoint [5] 372338 0
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).
Secondary outcome [6] 372339 0
Maternal health-related quality of life, measured with the AQoL-4D (Hawthorne, Richardson, Day, Osborne, & McNeil, 2000).
Timepoint [6] 372339 0
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).
Secondary outcome [7] 372340 0
Maternal memory, measured using the Prospective and Retrospective Memory Questionnaire (PRMQ; Smith, Della Sala, Logie, & Maylor, 2000).
Timepoint [7] 372340 0
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).
Secondary outcome [8] 373881 0
Maternal anxiety symptoms measured using PROMIS Anxiety (Pilkonis et al., 2011),
Timepoint [8] 373881 0
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).
Secondary outcome [9] 394188 0
Infant sleep measured using the Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004), with additional items from the BISQ-R (Sadeh, Mindell, Luedtke, & Wiegand, 2009)
Timepoint [9] 394188 0
Will be assessed at 3 time points: 8 weeks postpartum (T3), 6 months postpartum (T4), and 12 months postpartum (T5).

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants will be randomized using a complete randomization scheme generated in advance. The randomization scheme will be generated and setup in REDCap by a member of the research staff who is (1) not involved in recruitment or delivery of intervention and (2) is not one of the study PIs. REDCap is a web application and back-end database model designed to support data capture for research studies. REDCap is an open source tool developed by Vanderbilt University to build and manage online forms for data collection (www.project-REDCap.org). REDCap was developed specifically around HIPAA-security guidelines with features such as data encryption. REDCap implements role-based security, which will be used to limit access based on user function to certain forms, reports and fields. To randomize a participant, an authorized research staff member will log in to REDCap, enter eligibility and stratification data on the participant and will receive the group allocation. Follow-up measures will either be self-completed or will be conducted by research staff who are blinded to the condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation. Block design with varying block sizes of 3 and 6 will be used. Random seeds will be generated to assure allocation concealment and pre-guessing of the allocation sequence at the end of each block. Randomization will be stratified by baseline ISI (<15 and > 14).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on an intention-to-treat basis. Missing data is expected in a longitudinal design, and will be addressed using mixed effects models, full information maximum likelihood when structural equation modeling (SEM) frameworks are applied, and multiple imputation in other analyses.

To examine group differences in primary and secondary outcomes at baseline and each subsequent time point (Aim 1 and Aim 2), multiple regression analyses will be conducted with treatment conditions (along with relevant covariates) as independent variable, and the outcome of interest as dependent variable. For Aim 2, path analyses will be conducted, with the presence of either intervention as predictors, infant sleep duration/quality and maternal sleep-related cognition and behaviours as mediators, and maternal insomnia symptom severity as the outcome.
Assuming 10% missing data at each follow-up, randomising 38 participants to each group will give the study 80% power (two tailed a=0.05) to detect a medium to large effect size (d = 0.7). The effect size estimation is based on a previous trial using the CBT-I intervention.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/09/2019
Actual
3/10/2019
Date of last participant enrolment
Anticipated
Actual
17/12/2020
Date of last data collection
Anticipated
26/03/2022
Actual
21/03/2022
Sample size
Target
114
Accrual to date
Final
127
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14194 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 27176 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 303231 0
University
Name [1] 303231 0
Monash University Graduate Research Student Funding/Developmental Research Funding
Country [1] 303231 0
Australia
Funding source category [2] 303466 0
Government body
Name [2] 303466 0
National Health and Medical Research Council
Country [2] 303466 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Innovation Walk, Monash University Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 303539 0
None
Name [1] 303539 0
Address [1] 303539 0
Country [1] 303539 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303777 0
Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 303777 0
Ethics committee country [1] 303777 0
Australia
Date submitted for ethics approval [1] 303777 0
30/04/2019
Approval date [1] 303777 0
26/07/2019
Ethics approval number [1] 303777 0
19/17

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94766 0
Dr Bei Bei
Address 94766 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 94766 0
Australia
Phone 94766 0
+61 3 9905 3903
Fax 94766 0
Email 94766 0
[email protected]
Contact person for public queries
Name 94767 0
Bei Bei
Address 94767 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 94767 0
Australia
Phone 94767 0
+61 3 9905 3903
Fax 94767 0
Email 94767 0
[email protected]
Contact person for scientific queries
Name 94768 0
Bei Bei
Address 94768 0
School of Psychological Sciences
Monash University
18 Innovation Walk
Clayton Campus, Clayton VIC 3800
Country 94768 0
Australia
Phone 94768 0
+61 3 9905 3903
Fax 94768 0
Email 94768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The research database will be made publicly available 7 years after the final publication, although we will de-identify the data by removing names, date of birth, addresses/contact details, and any information that may link the data to individual participants. These personally identifying data will be completely erased and destroyed.
When will data be available (start and end dates)?
Data will be available 7 years after the final publication. No end date.
Available to whom?
The de-identified database will be made available through Monash Figshare to maximize the potential benefit to the scientific and research community. Monash Figshare is a collaborative digital repository for Monash University researchers. Access is restricted to Monash researchers and graduate research students only.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
The database will be accessible via Monash Figshare.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AI0474 Three-arm randomised controlled trial of Cognitive Behavioural Therapy for Insomnia, a responsive bassinet, and sleep hygiene for preventing postpartum insomnia: Preliminary findings on maternal insomnia and sleep outcomes (Study for Mother-Infant Sleep)2022https://doi.org/10.1093/sleep/zsac079.471
Dimensions AI0475 Prevalence and Potential Benefits of Cannabis Use in Patients with Insomnia2022https://doi.org/10.1093/sleep/zsac079.472
Dimensions AI0476 A Mobile App-Based Behavioral Intervention for Insomnia Among College Students2022https://doi.org/10.1093/sleep/zsac079.473
N.B. These documents automatically identified may not have been verified by the study sponsor.