Three Model Care Pathways for Postnatal Depression

• Sponsor: University of Melbourne (Other)
• Overall Status: Completed
• CT.gov ID: NCT01002027
• Collaborator: Beyondblue (The National Depression Initiative) (Other)
• Enrollment: 68
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Postnatal Depression	Behavioral: CBT-Counselling	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Feb 1, 2007
• Actual Study Completion Date: Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBT-counselling with Nurse CBT-counselling with Maternal Health Nurse, adjunctive to 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).
Active Comparator: CBT-Counselling by Psychologist CBT-counselling with Psychologist, adjunctive to 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).
No Intervention: Routine management Ongoing management by general medical practitioner

Outcome Measures

Primary Outcome Measures

1. Clinical Depression Score [8 weeks post-randomization]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• English-speaking women at 3-months postpartum

Exclusion Criteria:

• Psychosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Austin Health	Melbourne	Victoria	Australia	3081

Sponsors and Collaborators

• University of Melbourne
• Beyondblue (The National Depression Initiative)

Investigators

• Principal Investigator: Jeannette Milgrom, PhD, University of Melbourne & Austin Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01002027
• Other Study ID Numbers: H2005/01895
• First Posted: Oct 27, 2009
• Last Update Posted: Oct 27, 2009
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: Postnatal Depression; CBT-Counselling; Primary care
• Additional relevant MeSH terms: Depression, Postpartum; Depression; Depressive Disorder

Study Results

No Results Posted as of Oct 27, 2009