Three Model Care Pathways for Postnatal Depression

Postnatal Depression Clinical Trial

Official title:

Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002027
• Other study ID #: H2005/01895
• Status: Completed
• Phase: N/A
• First received: October 23, 2009
• Last updated: October 26, 2009
• Start date: November 2004
• Est. completion date: February 2007

Study information

• Verified date: October 2009
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking women at 3-months postpartum

Exclusion Criteria:

• Psychosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postnatal Depression

Intervention

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).

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	Beyondblue (The National Depression Initiative)

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Depression Score		8 weeks post-randomization	No