Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000474459
Ethics application status
Approved
Date submitted
18/03/2016
Date registered
11/04/2016
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Date results provided
23/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Treating postnatal depression with psychotherapy inclusive of the mother-baby relationship.
Scientific title
An interpersonal psychotherapy inclusive of the mother-baby relationship versus treatment-as-usual for postnatally depressed women: A multi-centre controlled trial.
Secondary ID [1] 288778 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal depression 298043 0
Maternal-child relational problems 298044 0
Condition category
Condition code
Mental Health 298203 298203 0 0
Depression
Reproductive Health and Childbirth 298441 298441 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a controlled trial with cluster allocation of participants identified by their maternal and child health nurse as being at risk of mood disorder. Participants who meet SCID criteria for major depressive episode (post partum onset) will be cluster allocated in groups of between three and five to one of two conditions: either treatment as usual via their maternal and child health nurse; or treatment as usual PLUS a group therapy of a 10-week Interpersonal Psychotherapy (IPT) with mother-child content (IPT-MC). Assessment will be made by mental health clinicians qualified to administer SCID (at least provisional psychologist status).
Treatment: Group facilitators will be psychologists with specific training in IPT-MC. The intervention is 10 x weekly 1.5 hour session. There is an additional partners-only session for the partners of participants, conducted during either Week 7 or Week 8. This psychoeducational in nature only, providing information on PND and suggestions to support their spouse focussed on listening to requests for support, and emphasising both instrumental and emotional support as options.
IPT focusses on communication strategies used by participants to gather, access, and negotiate both emotional and instrumental support. The sessions involve participants brainstorming and working on communication strategies. Particular focus is paid to the role transition to parenthood and how that affects social support; communication with the new baby; communication with their partner; and communication with other social supports. Participants are strongly encouraged to attend all 10 sessions and monitored however are not excluded if they miss sessions.
Intervention code [1] 294224 0
Treatment: Other
Intervention code [2] 294433 0
Behaviour
Comparator / control treatment
TAU: All participants, including those allocated to the treatment as usual group, will receive their normal 'best practice' care by their Maternal and Child Health Nurse, including any option as currently exist in the community. This includes referral to GP for psychological intervention/medication, sleep interventions ("sleep school"), educational, support, or intervention groups, or "new parents" group for those with babies of appropriate age.
Control group
Active

Outcomes
Primary outcome [1] 297711 0
Change in scores from baseline on the Emotional Availability Scales
Timepoint [1] 297711 0
6 months after baseline
Primary outcome [2] 297930 0
Change in scores from baseline on the Parenting Stress Index.
Timepoint [2] 297930 0
6 months after baseline
Primary outcome [3] 297950 0
Change in scores from baseline on the Infant Characteristics Questionnaire
Timepoint [3] 297950 0
6 months after baseline
Secondary outcome [1] 321962 0
Change in scores from baseline on the Maternal Attachment Inventory
PLEASE NOTE THAT THIS IS A PRIMARY OUTCOME (OUTCOME #4)
Timepoint [1] 321962 0
6 months after baseline
Secondary outcome [2] 322668 0
Change in scores from baseline on expected outcomes of IPT:
- Beck Depression Inventory
Timepoint [2] 322668 0
6 months after baseline
Secondary outcome [3] 322733 0
Change in scores from baseline on expected outcomes of IPT:
- Beck Anxiety Inventory
Timepoint [3] 322733 0
6 months after baseline
Secondary outcome [4] 322734 0
Change in scores from baseline on expected outcomes of IPT:
- Social Adjustment Scale - Short Form
Timepoint [4] 322734 0
6-months after baseline

Eligibility
Key inclusion criteria
Women with a SCID diagnosis of major depressive episode who are 18 years of age or older and have a child under 12 months at the commencement of the study, will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women need to have a sufficient grasp of English to participate in a group therapy, and this will be determined by their ability to participate fully in the assessment interview. If they are unable to understand the content of any of the interview questions or are unable to verbally communicate their answers, they will be considered to not be able to benefit from a group therapy. Women will also be excluded if they fulfill any of the following criteria: current substance abuse, diagnosed manic/hypomanic episode or psychosis; current inpatient psychiatric admission; or participation with any of their children in an attachment-based mother-child intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a cluster allocation procedure in which groups of three to five women are grouped together. The first three women who agree to participate in the trial in the same Council site, are grouped together. This group may include three, four, or five women if additional women become eligible for inclusion within three weeks of the allocation being made. The allocation is made once three women are eligible to be grouped. The next group of three to five women is again grouped based on location and a cutoff of three weeks after the date that three women become available. This group is allocated to the alternate condition. For example, if the first allocation was to IPT-MC, the next group are automatically allocated to TAU. The purpose of cluster allocation is to reduce the amount of time eligible women spend waiting to participate in the program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An umbrella MANOVA will test the main and interaction effects for a design incorporating 2 treatment groups (between groups) x 3 treatment times (within groups) x 4 response variables. MANOVA will be completed for the primary outcomes (EAS maternal sensitivity, maternal attachment self-report, parenting stress, and infant behaviours). A separate 2 x 3 x 3 MANOVA will then be completed for the secondary outcomes (depression, anxiety, and social adjustment).
Repeated measures ANOVA follow-up tests will be conducted for each individual measure, and those that reveal significant effects would have t-tests for individual differences. This is in line with the approach taken by Forman et al (2003) in their study on the effects of IPT on maternal sensitivity. Planned contrast between-groups, two-tailed t-tests would test the individual differences between the mean scores (change from baseline) for the control and intervention groups at each time point. With an alpha level of 0.05 and a power level of 0.8, the effect size was set based on estimated MAI scores from the Mulcahy et al (2010) study of group IPT for PND. This gives an initial sample size required of n=32 participants. To account for moderate clustering within the groups, the number was increased by 50% to n=48 participants, and rounded to 50.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/04/2014
Date of last participant enrolment
Anticipated
31/12/2016
Actual
30/12/2016
Date of last data collection
Anticipated
Actual
28/07/2017
Sample size
Target
50
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293146 0
Government body
Name [1] 293146 0
Moonee Valley City Council
Country [1] 293146 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Department of Psychiatry
Faculty of Medicine, Dentistry and Health Sciences
The University of Melbourne
Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 291941 0
None
Name [1] 291941 0
Address [1] 291941 0
Country [1] 291941 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294642 0
The University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 294642 0
Ethics committee country [1] 294642 0
Australia
Date submitted for ethics approval [1] 294642 0
01/05/2013
Approval date [1] 294642 0
23/05/2013
Ethics approval number [1] 294642 0
1238586.2

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64454 0
Prof Anne Buist
Address 64454 0
Department of Psychiatry
The University of Melbourne
Melbourne, Victoria 3010
Country 64454 0
Australia
Phone 64454 0
+61 3 8344 8975
Fax 64454 0
Email 64454 0
[email protected]
Contact person for public queries
Name 64455 0
Carolyn Deans
Address 64455 0
College of Arts
Victoria University
PO Box 14428
Melbourne Victoria 8001
Country 64455 0
Australia
Phone 64455 0
+61 3 9919 2334
Fax 64455 0
Email 64455 0
[email protected]
Contact person for scientific queries
Name 64456 0
Carolyn Deans
Address 64456 0
College of Arts
Victoria University
PO Box 14428
Melbourne Victoria 8001
Country 64456 0
Australia
Phone 64456 0
+61 3 9919 2334
Fax 64456 0
Email 64456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.