NCT01002027

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

2.3 years

First QC Date

October 23, 2009

Last Update Submit

October 26, 2009

Conditions

Keywords

Postnatal DepressionCBT-CounsellingPrimary care

Outcome Measures

Primary Outcomes (1)

  • Clinical Depression Score

    8 weeks post-randomization

Study Arms (3)

CBT-counselling with Nurse

ACTIVE COMPARATOR

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

Behavioral: CBT-Counselling

CBT-Counselling by Psychologist

ACTIVE COMPARATOR

CBT-counselling with Psychologist, adjunctive to management by general medical practitioner

Behavioral: CBT-Counselling

Routine management

NO INTERVENTION

Ongoing management by general medical practitioner

Interventions

CBT-CounsellingBEHAVIORAL

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).

CBT-Counselling by PsychologistCBT-counselling with Nurse

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English-speaking women at 3-months postpartum

You may not qualify if:

  • Psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Austin Health

Melbourne, Victoria, 3081, Australia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Jeannette Milgrom, PhD

    University of Melbourne & Austin Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2009

First Posted

October 27, 2009

Study Start

November 1, 2004

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations