Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000635965
Ethics application status
Approved
Date submitted
1/06/2011
Date registered
22/06/2011
Date last updated
20/10/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Help-seeking for postnatal depression as a major public health problem: A cluster randomised controlled trial of motivational interviewing
Scientific title
Motivational interviewing to facilitate help-seeking for postnatal depression by mothers in the first year following childbirth: A cluster randomised controlled trial
Secondary ID [1] 262288 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 267999 0
Condition category
Condition code
Mental Health 268127 268127 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational Interviewing. Maternal and child health (MCH) nurses in this condition will receive training in motivational interviewing over two, 5-6 hour interactive small group sessions. Training will be provided by a psychologist experienced in motivational interviewing and will cover the "Spirit", principles and core skills of motivational interviewing. MCH nurses will then deliver a brief motivational interviewing intervention (approximately 10 minutes) during their routine appointments with new mothers at 4-weeks, 8-weeks and 4-months postpartum. The MCH nurses will follow a detailed manual and will receive a supervision session by telephone around two weeks after the training sessions (approximately 20 minutes). The motivational interviewing intervention provides guidance for MCH nurses about the way to talk with mothers about how they are managing.
Intervention code [1] 266684 0
Other interventions
Comparator / control treatment
Standard care. Maternal and child health (MCH) nurses in this condition will continue to follow their usual practice when talking with mothers about how they are managing.
Control group
Active

Outcomes
Primary outcome [1] 266876 0
Percentage of participants reporting that they sought help for personal-emotional problems as measured by a dichotomous variable (yes/no)
Timepoint [1] 266876 0
7-weeks, 15-weeks and 12-months postpartum
Secondary outcome [1] 276548 0
Beck Depression Inventory Score
Timepoint [1] 276548 0
7-weeks, 15-weeks and 12-months postpartum

Eligibility
Key inclusion criteria
Ability to understand spoken and written English.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
nil

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised administration of a coded, pre-generated allocation schedule by an independent person blind to coding. Allocation is concealed from researchers and maternal and child health nurses until the point of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length permuted blocks, computer-generated random sequence. The allocation schedule has been stratified by municipality.
Masking / blinding
Blinded (masking 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
Recruiting
Date of first participant enrolment
Anticipated
6/10/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267174 0
Charities/Societies/Foundations
Name [1] 267174 0
Australian Rotary Health
Country [1] 267174 0
Australia
Primary sponsor type
Individual
Name
Professor Jeannette Milgrom
Address
Parent-Infant Research Institute
Level 1, South Wing, Centaur Building
Heidelberg Repatriation Hospital
300 Waterdale Rd
Hiedelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 266248 0
None
Name [1] 266248 0
Address [1] 266248 0
Country [1] 266248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269167 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 269167 0
Ethics committee country [1] 269167 0
Australia
Date submitted for ethics approval [1] 269167 0
Approval date [1] 269167 0
16/02/2011
Ethics approval number [1] 269167 0
H2011/04180

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

Contacts
Principal investigator
Name 32685 0
Address 32685 0
Country 32685 0
Phone 32685 0
Fax 32685 0
Email 32685 0
Contact person for public queries
Name 15932 0
Dr Charlene Schembri
Address 15932 0
Parent-Infant Research Institute
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 15932 0
Australia
Phone 15932 0
+61 3 9496 4496
Fax 15932 0
+61 3 9496 4148
Email 15932 0
[email protected]
Contact person for scientific queries
Name 6860 0
Dr Charlene Schembri
Address 6860 0
Parent-Infant Research Institute
Heidelberg Repatriation Hospital
300 Waterdale Rd
Heidelberg Heights VIC 3081
Country 6860 0
Australia
Phone 6860 0
+61 3 9496 4496
Fax 6860 0
+61 3 9496 4148
Email 6860 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Holt, C., Milgrom, J., & Gemmill, A.W. (2017). Imp... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving help-seeking for postnatal depression and anxiety: a cluster randomised controlled trial of motivational interviewing.2017https://dx.doi.org/10.1007/s00737-017-0767-0
N.B. These documents automatically identified may not have been verified by the study sponsor.