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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01002027




Registration number
NCT01002027
Ethics application status
Date submitted
23/10/2009
Date registered
27/10/2009
Date last updated
27/10/2009

Titles & IDs
Public title
Three Model Care Pathways for Postnatal Depression
Scientific title
Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
Secondary ID [1] 0 0
H2005/01895
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - CBT-Counselling

Active comparator: CBT-counselling with Nurse - CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner

Active comparator: CBT-Counselling by Psychologist - CBT-counselling with Psychologist, adjunctive to management by general medical practitioner

No intervention: Routine management - Ongoing management by general medical practitioner


BEHAVIORAL: CBT-Counselling
Intervention entailed six sessions of counselling-CBT delivered either by a trained Nurse, or by a Psychologist. Sessions focussed on: psycho-education about PND, main issues of concern, assessment of symptom severity, problem solving. Behavioural interventions (pleasant activities, anxiety management, relaxation, relationship communication) were used together with cognitive interventions (understanding links between thoughts and feelings, increasing positive thoughts, challenging negative self-talk and unhelpful beliefs).
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical Depression Score
Timepoint [1] 0 0
8 weeks post-randomization

Eligibility
Key inclusion criteria
* English-speaking women at 3-months postpartum
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Psychosis

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2007
Sample size
Target
Accrual to date
Final
68
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3081 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Beyondblue (The National Depression Initiative)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The study evaluates three best-practice care pathways for postnatal depression (PND) by comparing sole General Practitioner (GP) management to GP management in combination with CBT-based counselling from either a Psychologist or a Maternal and Child Health Nurse (MCHN).
Trial website
https://clinicaltrials.gov/study/NCT01002027
Trial related presentations / publications
Milgrom J, Holt CJ, Gemmill AW, Ericksen J, Leigh B, Buist A, Schembri C. Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling. BMC Psychiatry. 2011 May 27;11:95. doi: 10.1186/1471-244X-11-95.
Public notes

Contacts
Principal investigator
Name 0 0
Jeannette Milgrom, PhD
Address 0 0
University of Melbourne & Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01002027