Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000055303
Ethics application status
Approved
Date submitted
5/12/2016
Date registered
11/01/2017
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Can better sleep health during pregnancy regulate depressive symptoms in women with a previous history of depression?
Scientific title
Can better sleep health during pregnancy regulate depressive symptoms in women with a previous history of depression?
Secondary ID [1] 290512 0
Nil known
Universal Trial Number (UTN)
U1111-1190-4767
Trial acronym
Sleep HAPi (Sleep Health and Pregnancy Information)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Depression 300916 0
Sleep 300917 0
Condition category
Condition code
Reproductive Health and Childbirth 300728 300728 0 0
Antenatal care
Mental Health 300729 300729 0 0
Depression
Reproductive Health and Childbirth 300730 300730 0 0
Normal pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sleep HAPi is an individualised education package of information and strategies for healthy sleep during pregnancy, tailored for each participant in each trimester. Sleep HAPi is an intervention specifically designed for this study and will be used in each of the three intervention weeks; one intervention per trimester (this corresponds to time points 2, 3 and 4 – see ‘Study Process’ document attached to this ANZCTR registration form).

The package comprises of:
+ A booklet providing evidence based material on:
* The basic physiology of sleep;
* The benefits of healthy sleep and consequences of poor sleep;
* The fundamental principles of achieving healthy sleep;
* Trimester specific sleep changes and expectations;
* Trimester specific sleep suggestions.
+ A summary of the actigraphy data from the measurement week prior.

The package is designed to be expanded on over the three intervention weeks, with the majority of information provided and discussed in the first intervention week, with additional trimester specific information and actigraphy data added as the study, and pregnancy, progress.

The study will utilise both subjective and objective measures of sleep. The subjective measures will be obtained from six questionnaires at all six time points (see ‘Study Process’ attached). The first questionnaire at T1 (study commencement) is expected to take 10 minutes, the questionnaire at T2 (11-14 weeks gestation) approximately 30-40 minutes, the questionnaires at T3 (21-24 weeks gestation), T4 (32-35 weeks gestation), T5 (6 weeks postnatal) and T6 (12 weeks postnatal) approximately 20-30 minutes each. The first questionnaire will be completed at the initial meeting with the participant, while the remainder will be posted to the participant for completion in their own time within a specified date range.

The objective measures will be obtained from a total of six weeks of actigraphy and sleep diaries at T2, T3 and T4 - two separate weeks at each time point, one before the intervention and one after. The participant will wear an actiwatch and fill out a sleep diary for a seven day period. It is expected that filling out the sleep diaries will take no more than 10 minutes per day.

Analysis of the objective and subjective measures will elucidate the participant’s sleep behaviours and patterns, which will then be discussed with the participant during the intervention. Relevant suggestions from the Sleep HAPi booklet will then be explored in an attempt to improve sleep. The actigraphy week immediately following each intervention will indicate adherence and whether the sleep suggestions are improving the participant’s sleep.

The interventions are a one-on-one, face-to-face meeting scheduled at T2, T3 and T4. These meetings, delivered by a Sleep Scientist, will take place at either the participant’s home, or at the Sleep/Wake Research Centre’s meeting rooms. The first intervention at T2 is expected to be 60-90 minutes in length, with subsequent interventions at T3 and T4 expected to be 45-60 minutes in length.

Intervention fidelity is addressed by having a single researcher delivering the education package. Intervention adherence will be assessed using an action and reflection plan. At each intervention time point, the researcher and participant will discuss and develop a sleep action plan. Actigraphy in the week following the intervention will be assessed to determine adherence to the action plan, and the subsequent intervention will be used to reflect on the effectiveness of the plan.

Intervention code [1] 296526 0
Prevention
Intervention code [2] 296527 0
Treatment: Other
Intervention code [3] 296528 0
Behaviour
Comparator / control treatment
From October 2009 to October 2012, the Sleep/Wake Research Centre at Massey University (Wellington, New Zealand) conducted a large Health Research Council (HRC) funded project entitled 'E Moe Mama: Maternal Sleep and Health in Aotearoa/New Zealand', with a cohort comprising of 1144 women: 407 Maori and 737 non-Maori women. It was a questionnaire-based project designed to investigate relationships between sleep changes across the perinatal period and maternal health, wellbeing and mood. Comprehensive questionnaires were administered at 35-37 weeks gestation and 12 weeks postpartum, and a phone interview completed at 4-6 weeks postpartum.

The second phase of the study, entitled 'Moe Kura', began after additional funding from Massey University was granted in late 2012. Moe Kura investigated the sleep and wellbeing of the same woman and child, with each pair followed up with an additional questionnaire when the child was 3 years of age.
Control group
Historical

Outcomes
Primary outcome [1] 300349 0
Incidence of depression in pregnancy and the postnatal period using the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory II (BDI-II).
Timepoint [1] 300349 0
Incidence of depression will be measured at T2, T3, T4, T5 and T6 - three antenatal time points (end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Primary outcome [2] 300350 0
Rate of change of depression in pregnancy and postnatal period using the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory II (BDI-II).
Timepoint [2] 300350 0
Rate of change of depression will be measured across T2, T3, T4, T5 and T6 - three antenatal time points (end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Primary outcome [3] 300529 0
Sleep timing during pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, a study questionnaire specifically designed for this study (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)).
Timepoint [3] 300529 0
Sleep timing will be measured at T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [1] 329758 0
The change of sleep timing across pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, a study questionnaire specifically designed for this study (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)). THIS IS A PRIMARY OUTCOME.
Timepoint [1] 329758 0
The change in sleep timing will be measured across T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [2] 330233 0
Sleep duration during pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, a study questionnaire specifically designed for this study (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)). THIS IS A PRIMARY OUTCOME.
Timepoint [2] 330233 0
Sleep duration will be measured at T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [3] 330234 0
The change in sleep duration across pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, study questionnaires (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)). THIS IS A PRIMARY OUTCOME.
Timepoint [3] 330234 0
The change in sleep duration will be measured across T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [4] 330236 0
Sleep quality during pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, a study questionnaire specifically designed for this study (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)). THIS IS A PRIMARY OUTCOME.
Timepoint [4] 330236 0
Sleep quality will be measured at T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [5] 330238 0
The change in sleep quality across pregnancy and the early postnatal period as measured by actigraphy, sleep diaries, study questionnaires (Sleep and Health during Pregnancy) and structured questionnaires (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS), General Sleep Disturbance Scale (GSDS), Munich Chronotype Questionnaire (MCTQ)). THIS IS A PRIMARY OUTCOME.
Timepoint [5] 330238 0
The change in sleep quality will be measured across T1, T2, T3, T4, T5 and T6 - four antenatal time points (one at study entry (retrospective) and one at the end of each trimester) and two postnatal time points (six and 12 weeks postnatal).
Secondary outcome [6] 330239 0
To assess if recruitment is possible for this study design, using a questionnaire designed specifically for this study.
Timepoint [6] 330239 0
Recruitment will be assessed at T1 (first trimester).
Secondary outcome [7] 330240 0
To assess if retention is possible for this study design, using a questionnaire designed specifically for this study..
Timepoint [7] 330240 0
Retention will be assessed at T6 (12 weeks postnatal).

Eligibility
Key inclusion criteria
Women will be eligible to participate if they:
*Are less than 13 weeks gestation;
*Have had a diagnosis of depression;
*Are over 16 years of age;
*Are primiparous;
*Have no children living at home under the age of three;
*Are proficient in English.
Minimum age
16 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women will be excluded if they:
*Are taking any depressive medication;
*Have current depressive symptomology;
*Have a diagnosed sleep conditions (such as OSA or restless leg syndrome);
*Have a history of severe mental illness, such as psychotic disorders.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There is insufficient information to perform power calculations. It is considered that 30 women will provide sufficient information on how items were being interpreted and completed.
There are 6 measurement time points, four of which are antenatal and 2 of which are postnatal. Analysis will examine the pattern of responses to demographic items, scales and items within the scales. Logistic regression analysis will be completed at each time point and a mixed model repeated measures analysis of variants will evaluate the outcome measures over time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2017
Actual
1/03/2017
Date of last participant enrolment
Anticipated
28/02/2018
Actual
14/02/2018
Date of last data collection
Anticipated
1/12/2018
Actual
7/12/2018
Sample size
Target
30
Accrual to date
Final
22
Recruitment outside Australia
Country [1] 8423 0
New Zealand
State/province [1] 8423 0
Greater Wellington

Funding & Sponsors
Funding source category [1] 295078 0
University
Name [1] 295078 0
Massey University
Country [1] 295078 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Wallace Street, Mount Cook, Wellington, 6021
Country
New Zealand
Secondary sponsor category [1] 293890 0
Individual
Name [1] 293890 0
Clare Ladyman
Address [1] 293890 0
PhD Student
Sleep/Wake Research Centre
Massey University
Wallace Street, Mount Cook, Wellington, 6021
Country [1] 293890 0
New Zealand
Secondary sponsor category [2] 293891 0
Individual
Name [2] 293891 0
Associate Professor Leigh Signal
Address [2] 293891 0
Primary Supervisor
Sleep and Circadian Researcher
Sleep/Wake Research Centre
Massey University
Wallace Street, Mount Cook, Wellington, 6021
Country [2] 293891 0
New Zealand
Secondary sponsor category [3] 293892 0
Individual
Name [3] 293892 0
Dr Bronwyn Sweeney
Address [3] 293892 0
Co-Supervisor
Sleep and Circadian Researcher/Clinical Psychologist
Sleep/Wake Research Centre
Massey University
Wallace Street, Mount Cook, Wellington, 6021
Country [3] 293892 0
New Zealand
Secondary sponsor category [4] 293893 0
Individual
Name [4] 293893 0
Professor Philippa Gander
Address [4] 293893 0
Co-Supervisor
Sleep and Circadian Researcher
Sleep/Wake Research Centre
Massey University
Wallace Street, Mount Cook, Wellington, 6021
Country [4] 293893 0
New Zealand
Secondary sponsor category [5] 293894 0
Individual
Name [5] 293894 0
Dr Mark Huthwaite
Address [5] 293894 0
Co-Supervisor
Perinatal Psychiatrist, Specialist Maternal Mental Health Service
Associate Dean of Student Affairs
Otago University
23 Mein St, Newtown, Wellington 6242
Country [5] 293894 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296431 0
Massey University, Human Ethics Committee (Southern A)
Ethics committee address [1] 296431 0
Ethics committee country [1] 296431 0
New Zealand
Date submitted for ethics approval [1] 296431 0
26/04/2016
Approval date [1] 296431 0
13/07/2016
Ethics approval number [1] 296431 0
SOA16/29

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1276 1276 0 0
/AnzctrAttachments/371829-Ethics Approval Letter.pdf (Ethics approval)
Attachments [2] 1335 1335 0 0
/AnzctrAttachments/371829(v15-12-2016-12-44-48)-Study Process.pdf (Other)

Contacts
Principal investigator
Name 70374 0
Mrs Clare Ladyman
Address 70374 0
Massey University, Wallace Street, Mount Cook, Wellington, 6021
Country 70374 0
New Zealand
Phone 70374 0
+64 (0)4 979 3024
Fax 70374 0
Email 70374 0
[email protected]
Contact person for public queries
Name 70375 0
Clare Ladyman
Address 70375 0
Massey University, Wallace Street, Mount Cook, Wellington, 6021
Country 70375 0
New Zealand
Phone 70375 0
+64 (0)4 979 3024
Fax 70375 0
Email 70375 0
[email protected]
Contact person for scientific queries
Name 70376 0
Clare Ladyman
Address 70376 0
Massey University, Wallace Street, Mount Cook, Wellington, 6021
Country 70376 0
New Zealand
Phone 70376 0
+64 (0)4 979 3024
Fax 70376 0
Email 70376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.