Postnatal DepressionNCT01002027
Three Model Care Pathways for Postnatal Depression
A study testing CBT-Counselling in people with Postnatal Depression, run by University of Melbourne at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postnatal Depression
- What is being tested?
- CBT-Counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2004to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking women at 3-months postpartum
Who cannot join
- Psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
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).
- Conditions
- Postnatal Depression
- Being tested
- CBT-Counselling
- Keywords
- Postnatal Depression, CBT-Counselling, Primary care
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-CounsellingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| CBT-counselling with Nurse | Active comparator | CBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner Receives: Behavioral: CBT-Counselling |
| CBT-Counselling by Psychologist | Active comparator | CBT-counselling with Psychologist, adjunctive to management by general medical practitioner Receives: Behavioral: CBT-Counselling |
| Routine management | No intervention | Ongoing management by general medical practitioner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Depression Score
Measured: 8 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startNov 2004
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postnatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Beyondblue (The National Depression Initiative)
- Investigators
- Jeannette Milgrom, PhD, Principal investigator, University of Melbourne & Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002027
- Sponsor's protocol ID
- H2005/01895
- Status last verified
- Oct 2009
- First submitted
- 23 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21615968
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Models of Care: Evaluating a Best Practice Model of Treating Postnatal Depression (PND)
- ClinicalTrials.gov ID
- NCT01002027
- Acronym / sponsor ID
- H2005/01895
- Conditions
- Postnatal Depression
- Keywords
- Postnatal Depression, CBT-Counselling, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Collaborators
- Beyondblue (The National Depression Initiative)
- Study start
- Nov 2004
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBT-counselling with Nurse | Active comparator | Behavioral: CBT-CounsellingCBT-counselling with Maternal Health Nurse, adjunctive to management by general medical practitioner |
| CBT-Counselling by Psychologist | Active comparator | Behavioral: CBT-CounsellingCBT-counselling with Psychologist, adjunctive to management by general medical practitioner |
| Routine management | No intervention | –Ongoing management by general medical practitioner |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- English-speaking women at 3-months postpartum
Key exclusion criteria (1 listed)
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-CounsellingIntervention 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). | Behavioural | CBT-Counselling by Psychologist, CBT-counselling with Nurse |
Primary outcome
Clinical Depression Score
Time frame: 8 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Derived from this study: PubMed 21615968Milgrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette Milgrom, PhD principal investigator
University of Melbourne & Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-Counselling in people with Postnatal Depression, run by University of Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Depression Score (time frame: 8 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009.