Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000926235
Ethics application status
Approved
Date submitted
26/08/2009
Date registered
28/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beating the Blues before Birth (individual treatment)
Scientific title
Beating the Blues before Birth - Evaluating an Antenatal Depression Treatment Program: A Randomised Controlled Trial
Secondary ID [1] 959 0
Nil
Universal Trial Number (UTN)
Trial acronym
BBBi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal depression and anxiety 243598 0
Condition category
Condition code
Mental Health 239880 239880 0 0
Depression
Mental Health 252275 252275 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women allocated to the intervention condition receive the 'Beating the Blues before Birth' treatment package, which consists of eight individual cognitive-behavioural therapy sessions with a psychologist (the woman's partner is invited to attend one of the sessions). Sessions are delivered weekly over 8 weeks and are an hour in length.

All women who participate (regardless of allocated condition) receive a clinical assessment with a specialist psychologist, help linking in with appropriate health professionals and support services, a 'community connections' pamphlet that we developed which encourages the use of community supports and includes a list of contacts for appropriate servcies, and an 'Emotional health during pregnancy and early parenthood' booklet from beyondblue.
Intervention code [1] 241153 0
Treatment: Other
Comparator / control treatment
Women allocated to the control condition receive routine primary care in which they will be case managed by their midwife or General Practitioner (GP) over the 8-week period.

All women who participate (regardless of allocated condition) receive a clinical assessment with a specialist psychologist, help linking in with appropriate health professionals and support services, a 'community connections' pamphlet that we developed which encourages the use of community supports and includes a list of contacts for appropriate servcies, and an 'Emotional health during pregnancy and early parenthood' booklet from beyondblue.
Control group
Active

Outcomes
Primary outcome [1] 240616 0
Depression as measured by the Beck Depression Inventory (BDI-II)
Timepoint [1] 240616 0
Baseline, Post-treatment, 6 months postpartum
Secondary outcome [1] 257253 0
Anxiety as measured by the Beck Anxiety Inventory (BAI)
Timepoint [1] 257253 0
Baseline, Post-treatment, 6 months postpartum
Secondary outcome [2] 257254 0
Social support as measured by the Social Provisions Scale (SPS)
Timepoint [2] 257254 0
Baseline, Post-treatment, 6 months postpartum

Eligibility
Key inclusion criteria
Participants will be women aged 18 years or over who are less than 32 weeks pregnant and who meet the Diagnostic amd Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for either Major Depression, Minor Depression, Adjustment Disorder with depressed mood, or Adjustment Disorder with mixed anxiety and depressed mood.
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: Co-morbid Axis I disorder or medical condition likely to interfere with participation, risk requiring crisis management, participation in other psychological programs, and significant difficulty with English.

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)
Centralised administration of a coded, pre-generated allocation schedule by an independent person blind to coding. Treatment assignment is concealed from researchers, therapists, and participants until the point of allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length premuted blocks, computer-generated random sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237539 0
Charities/Societies/Foundations
Name [1] 237539 0
MBF Foundation
Country [1] 237539 0
Australia
Primary sponsor type
Other
Name
Parent-Infant Research Institute
Address
Heidelberg Repatriation Hospital, Level 1, South Wing, Centaur Building, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country
Australia
Secondary sponsor category [1] 237019 0
None
Name [1] 237019 0
Address [1] 237019 0
Country [1] 237019 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243677 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 243677 0
Henry Buck Building, Austin Hospital, 145 Studley Rd, Heidelberg VIC 3084
Ethics committee country [1] 243677 0
Australia
Date submitted for ethics approval [1] 243677 0
Approval date [1] 243677 0
24/06/2009
Ethics approval number [1] 243677 0
H2009/03548

Summary
Brief summary
Depression during pregnancy (antenatal depression) is a clinical condition in its own right, which has been under-recognised and is in urgent need of an evidence-based treatment. This study will evaluate our Beating the Blues before Birth (BBB) program as a treatment for antenatal depression. It is hypothesised that women receiving the BBB program will report less depression and anxiety at post-treatment and at 6-month follow-up than women in the routine care condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30070 0
Address 30070 0
Country 30070 0
Phone 30070 0
Fax 30070 0
Email 30070 0
Contact person for public queries
Name 13317 0
Dr Charlene Schembri
Address 13317 0
Parent-Infant Research Institute, Dept. of Clinical & Health Psychology, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 13317 0
Australia
Phone 13317 0
+61 3 9496 4496
Fax 13317 0
Email 13317 0
[email protected]
Contact person for scientific queries
Name 4245 0
Dr Charlene Schembri
Address 4245 0
Parent-Infant Research Institute, Dept. of Clinical & Health Psychology, Heidelberg Repatriation Hospital, 300 Waterdale Rd, Heidelberg Heights VIC 3081
Country 4245 0
Australia
Phone 4245 0
+61 3 9496 4496
Fax 4245 0
Email 4245 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.