Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000859987
Ethics application status
Approved
Date submitted
11/05/2011
Date registered
12/08/2011
Date last updated
7/07/2022
Date data sharing statement initially provided
7/07/2022
Date results provided
7/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An Early Sleep Psychoeducational Intervention to improve sleep management and reduce depressive symptoms in new mothers
Scientific title
An Early Sleep Psychoeducational Intervention to improve sleep management and reduce depressive symptoms in new mothers
Secondary ID [1] 259770 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Natal Depression 261349 0
Sleep deprivation during post natal period 265826 0
Mother child relationship 265827 0
Baby's feeding schedule 265828 0
Baby's sleep patterns 265864 0
Condition category
Condition code
Reproductive Health and Childbirth 265984 265984 0 0
Childbirth and postnatal care
Mental Health 265985 265985 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A:
We shall be providing sleep and mood information in a psychoeducational intervention (interactive slide presentation) in a group setting and booklets about sleep, relaxation and babies' sleep to first time parents in the third trimester. Due to parental time restraints we are intending to provide only two 1.5 hour sessions as research has shown that one session can be almost as effective as 4 sessions. The group sessions will be run by a Sleep Psychologist and will consist of groups of 4-10 couples or individuals. These participants will also receive a phone call at 3 and 6 weeks following delivery to monitor their progress and answer any questions they may have. Participants will complete questionnaires at baseline (prenatal), 6 weeks, 4 months and 10 months following delivery.
Intervention code [1] 264199 0
Prevention
Intervention code [2] 264564 0
Behaviour
Comparator / control treatment
Our control group will consist of first time parents-to-be, who will not attend the psychoeducational session but will receive information about sleep hygiene, relaxation and babies’ sleep. They will receive a phone call at 3 and 6 weeks following delivery to monitor their progress. This group will also complete the same questionnaires as Group A at baseline (prenatal), 6 weeks, 4 months and 10 months following delivery.
Control group
Active

Outcomes
Primary outcome [1] 262317 0
Sleep quality as indicated by scores on the Pittsburgh Sleep Quality Index, the Insomnia Severity Index, Multidimensional Assessment of Fatigue and the Epworth Sleepiness Scale. We hypothesise that the group receiving psychoeducation will have better sleep quality overall than the control group.

On approaching analysis, we realised that we had selected four questionnaires to measure the concept of sleep as primary outcomes. Therefore it should be noted that we will now be using the Bonferonni-Holm correction in order to share the 5% error rate between these questionnaires for our primary outcome
Timepoint [1] 262317 0
Prenatal, 6 weeks, 4 months and 10 months post natal.
Secondary outcome [1] 273526 0
Mothers depressive symptoms as assessed by the Edinbugh Post Natal Depression Scale and the Depression, Anxiety and Stress Scale. We hypothesise that the group receiving psychoeducation will have lower depressive symptoms than the control group
Timepoint [1] 273526 0
Prenatal, 6 weeks, 12 - 16 weeks and 10 months post natal
Secondary outcome [2] 276270 0
Coping with a newborn baby.
Brief Coping Scale to assess coping styles pre and post natal
Timepoint [2] 276270 0
Prenatal, 6 weeks, 12 - 16 weeks and 10 months post natal
Secondary outcome [3] 276338 0
More realistic beliefs about sleep whilst having a newborn
Measured through open ended queries on a generic questionnaire administered pre and post intervention. This generic questionnaire is not validated at present.
Timepoint [3] 276338 0
Prenatal, 6 weeks, 12 - 16 weeks and 10 months post natal
Secondary outcome [4] 276339 0
Experience of bonding demonstrated through scores on the Being a Mother & Bonding Scale (BaMB) which assesses the experience of motherhood. We hypothesis the psychoeducational group will have lower scores compared with the control group.
Timepoint [4] 276339 0
Prenatally
6 weeks post natal
12 - 16 weeks post natal

Eligibility
Key inclusion criteria
Women who are expecting their first baby and are in the third trimester of their pregnancy
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women with any significant medical condition, current major depression and or any psychotic disorder. Women who have English as a second language and have difficulty with written language will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment in will be achieved via sealed opaque envelopes prepared by the trial epidemiologist who also generated the random sequence who will play no role in the recruitment of patients. Investigators other than the epidemiologist will not have access to the random sequence until the end of the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We shall use a computer generated cluster randomisation sequence with a 1:1 ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/07/2012
Actual
14/01/2013
Date of last participant enrolment
Anticipated
Actual
18/07/2014
Date of last data collection
Anticipated
Actual
18/07/2015
Sample size
Target
214
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5605 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 13050 0
2037 - Glebe

Funding & Sponsors
Funding source category [1] 264647 0
Charities/Societies/Foundations
Name [1] 264647 0
BUPA
Country [1] 264647 0
Australia
Funding source category [2] 265045 0
Government body
Name [2] 265045 0
Centre for Integrated Research & Understanding of Sleep (CIRUS)
Country [2] 265045 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Woolcock Institute of Medical Research
PO BOx M77
Missenden Road
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 266528 0
None
Name [1] 266528 0
Address [1] 266528 0
Country [1] 266528 0
Other collaborator category [1] 252005 0
Individual
Name [1] 252005 0
Ms Maureen Ryan
Address [1] 252005 0
Maureen Ryan
Head of Department Low Risk Obstetrics
RPA Women and Babies
Missenden Road
Camperdown NSW 2050
Country [1] 252005 0
Australia
Other collaborator category [2] 252006 0
Individual
Name [2] 252006 0
Dr Bandana Saini
Address [2] 252006 0
Senior Lecturer
Faculty of Pharmacy, Research Theme: Respiratory

THE UNIVERSITY OF SYDNEY
Rm No S303, Building Name No A15 The University of Sydney NSW 2006
Country [2] 252006 0
Australia
Other collaborator category [3] 252141 0
Charities/Societies/Foundations
Name [3] 252141 0
Sutherland Early Support Service
Address [3] 252141 0
Contact: Anne Van Vuuren
Sutherland Early Support Service
Community Health Caringbah
The Sutherland Hospital
430 The Kingsway
Caringbah NSW 2232
Country [3] 252141 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266651 0
Sydney Local Health Network
Ethics committee address [1] 266651 0
Ethics committee country [1] 266651 0
Australia
Date submitted for ethics approval [1] 266651 0
14/03/2011
Approval date [1] 266651 0
28/04/2011
Ethics approval number [1] 266651 0
11/RPAH/49

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

Contacts
Principal investigator
Name 32334 0
Mrs Liora Kempler
Address 32334 0
Woolcock Institute of Medical Research
431 Glebe Point Rd, Glebe. NSW 2037
Country 32334 0
Australia
Phone 32334 0
+61291140495
Fax 32334 0
Email 32334 0
[email protected]
Contact person for public queries
Name 15581 0
Associate Professor Delwyn Bartlett
Address 15581 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown
NSW 2050
Country 15581 0
Australia
Phone 15581 0
+612 9114 0460
Fax 15581 0
+612 9114 0465
Email 15581 0
[email protected]; [email protected]
Contact person for scientific queries
Name 6509 0
Associate Professor Delwyn Bartlett
Address 6509 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown
NSW 2050
Country 6509 0
Australia
Phone 6509 0
+612 9114 0460
Fax 6509 0
+612 9114 0465
Email 6509 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?
Individual participant underlying published results only.
When will data be available (start and end dates)?
Data will be made available upon request, after publication, with no end date determined.
Available to whom?
Data will be made available upon request, after publication and will be determined upon negotiation with researchers who provided a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Secure data transfer and signed data access agreement. Contact: [email protected]


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
EmbaseA brief sleep focused psychoeducation program for sleep-related outcomes in new mothers: A randomized controlled trial.2020https://dx.doi.org/10.1093/sleep/zsaa101
N.B. These documents automatically identified may not have been verified by the study sponsor.