Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000397415
Ethics application status
Approved
Date submitted
24/07/2007
Date registered
2/08/2007
Date last updated
2/08/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Beating the Blues before Birth
Scientific title
Beating the Blues before Birth: Evaluating an Antenatal Depression Treatment Model as a Public Health Priority
Universal Trial Number (UTN)
Trial acronym
BBB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal depression 2190 0
Anxiety 2191 0
Social Support 2192 0
Condition category
Condition code
Mental Health 2285 2285 0 0
Depression
Mental Health 2286 2286 0 0
Anxiety
Reproductive Health and Childbirth 2287 2287 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention group is allocated to 8 sessions of a cognitive behavioural therapy group program and networked with health professionals. Each weekly session runs for an hour and a half and it is expected that women attend every session. Women in this condition will be case-managed by a midwife/health professional and referred to other agencies/services as necessary, as normally happens where specialised programs are not available.
Intervention code [1] 1906 0
Treatment: Other
Comparator / control treatment
Control group receive routine primary care and networking with health professionals over an 8 week period.
Control group
Active

Outcomes
Primary outcome [1] 3176 0
Beck Depression Inventory - Second Edition
Timepoint [1] 3176 0
At entry to trial (20-30 weeks of pregnancy) and post treatment.
Primary outcome [2] 3177 0
Beck Anxiety Inventory
Timepoint [2] 3177 0
At entry to trial (20-30 weeks of pregnancy) and post treatment.
Primary outcome [3] 3178 0
Social provisions scale
Timepoint [3] 3178 0
At entry to trial (20-30 weeks of pregnancy) and post treatment.
Secondary outcome [1] 5299 0
Beck Depression Inventory - Second Edition
Timepoint [1] 5299 0
At 3, 6 & 12 months follow-up.
Secondary outcome [2] 5300 0
Beck Anxiety Inventory
Timepoint [2] 5300 0
At 3, 6 & 12 months follow-up.
Secondary outcome [3] 5301 0
Social Provisions Scale
Timepoint [3] 5301 0
At 3, 6 & 12 months follow-up.
Secondary outcome [4] 5302 0
Information about birth & services used
Timepoint [4] 5302 0
At 6 month follow-up.

Eligibility
Key inclusion criteria
Participants will be women, 20-30 weeks pregnant, 18 years or over with a DSM-IV diagnosis of minor or major depression.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who are unable to understand written english; major health problem; concurrent major psychiatric disorder affecting competence to give informed consent (e.g., psychotic depression); risk requiring crisis management; and participation in other psychological programs.

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, double-blinded pre-generated allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A variable-length permuted 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
5/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2451 0
Charities/Societies/Foundations
Name [1] 2451 0
Australian Rotary Health Research Fund
Country [1] 2451 0
Australia
Primary sponsor type
Government body
Name
Parent-Infant Research InstituteAustin Health
Address
Country
Australia
Secondary sponsor category [1] 2223 0
Hospital
Name [1] 2223 0
The Northern Hospital, Melbourne
Address [1] 2223 0
Country [1] 2223 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4305 0
Austin Health
Ethics committee address [1] 4305 0
Ethics committee country [1] 4305 0
Australia
Date submitted for ethics approval [1] 4305 0
Approval date [1] 4305 0
17/05/2007
Ethics approval number [1] 4305 0
H2007/02835
Ethics committee name [2] 4306 0
Northern Hospital
Ethics committee address [2] 4306 0
Ethics committee country [2] 4306 0
Australia
Date submitted for ethics approval [2] 4306 0
Approval date [2] 4306 0
27/03/2007
Ethics approval number [2] 4306 0
15/07

Summary
Brief summary
Antenatal depression (AND) is at least as prevalent as postnatal depression and is an important risk factor for postnatal depression. Depression has major implications for women's well-being and for the health and well-being of their babies. Despite more than 1 in 10 women being affected by a clinical depression in pregnancy, treatment following identification is not part of routine antenatal care services. This study will test whether an 8 session cognitive behavioural group therapy program will reduce antenatal depression, anxiety and increase health service uptake compared to pregnant women not receiving the program. 100 women with a clinical diagnosis for depression will be randomised to either intervention or control group. Participants will be assessed by self-administered questionnaires pre and post treatment and at 3,6 and 12 month follow-up time points.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27720 0
Address 27720 0
Country 27720 0
Phone 27720 0
Fax 27720 0
Email 27720 0
Contact person for public queries
Name 11095 0
Christopher Holt
Address 11095 0
Parent-Infant Research Institute (PIRI) Department of Clinical & Health Psychology Heidelberg Repatriation Hospital
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 11095 0
Australia
Phone 11095 0
+61 (03) 9496 4496
Fax 11095 0
Email 11095 0
christopher.holt@austin.org.au
Contact person for scientific queries
Name 2023 0
Christopher Holt
Address 2023 0
Parent-Infant Research Institute (PIRI) Department of Clinical & Health Psychology Heidelberg Repatriation Hospital
Austin Health
300 Waterdale Rd
Heidelberg West VIC 3081
Country 2023 0
Australia
Phone 2023 0
+61 (03) 9496 4496
Fax 2023 0
Email 2023 0
christopher.holt@austin.org.au

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
SourceTitleYear of PublicationDOI
EmbaseSocial support-a protective factor for depressed perinatal women?.2019https://dx.doi.org/10.3390/ijerph16081426
EmbaseA 7-year follow-up of antenatal depression treatment with cognitive behavioral therapy: A case report of maternal and child outcomes.2019https://dx.doi.org/10.1177/2050313X19841463
EmbaseExploring the effect of antenatal depression treatment on children's epigenetic profiles: Findings from a pilot randomized controlled trial.2019https://dx.doi.org/10.1186/s13148-019-0616-2
EmbaseCognitive Behavioral Therapy for Antenatal Depression in a Pilot Randomized Controlled Trial and Effects on Neurobiological, Behavioral and Cognitive Outcomes in Offspring 3-7 Years Postpartum: A Perspective Article on Study Findings, Limitations and Future Aims.2020https://dx.doi.org/10.3389/fpsyt.2020.00034
N.B. These documents automatically identified may not have been verified by the study sponsor.