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Trial registered on ANZCTR


Registration number
ACTRN12613000113752
Ethics application status
Approved
Date submitted
25/01/2013
Date registered
30/01/2013
Date last updated
26/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Web-based Cognitive Behavioural Therapy for Women with
Postnatal Depression
Scientific title
A randomised controlled trial of MumMoodBooster, a web-based cognitive behavioural therapy program for the treatment of clinical depression in postnatal women
Secondary ID [1] 281830 0
Nil
Universal Trial Number (UTN)
Trial acronym
MMB (MumMoodBooster)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postnatal Depression 288184 0
Postnatal anxiety 288252 0
Condition category
Condition code
Mental Health 288548 288548 0 0
Depression
Mental Health 288549 288549 0 0
Anxiety
Reproductive Health and Childbirth 288605 288605 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MumMoodBooster is a Web-based treatment targeted to women with postnatal depression, completed over 9 weeks, with low-intensity support from a telephone coach.

The MumMoodBooster Web-based intervention consists of a series of six sequential interactive sessions (30 min sessions) based on Cognitive Behaviour Therapy. These are designed to be completed over 9 weeks, which allows women to schedule sessions to fit their own needs and to re-visit previously completed material. Additionally, intervention participants will be phoned weekly (up to 30 minutes) by a phone coach who will monitor their progress and encourage practice of the recommended strategies. Participants will also have access to a web support forum and a significant amount of content to view at any time in the form of companion library articles.
Intervention code [1] 286385 0
Treatment: Other
Intervention code [2] 286432 0
Behaviour
Comparator / control treatment
Standard Treatment: Women allocated to this condition will be referred to their nurse or GP with a summary of their diagnostic assessment. Support and/or referral to other services/agencies will then occur as necessary, as usually happens in circumstances in which specialised programs are not available.
Control group
Active

Outcomes
Primary outcome [1] 288707 0
Depressive episode remission.
For this outcome the Structured Clinical Interview for DSM-IV (SCID) will assess major Axis I and II psychiatric disorders using DSM-IV criteria at baseline and at 3-month follow-up
Timepoint [1] 288707 0
3 months
Primary outcome [2] 288708 0
Amelioration of depression and anxiety symptoms. Depression and anxiety symptom severity will be measured by the Revised Beck Depression Inventory (BDI-II) and by the anxiety sub-scale of the Depression Anxiety Stress Scales (DASS-21) respectively.
Timepoint [2] 288708 0
3 months
Secondary outcome [1] 300795 0
Putative CBT change mechanisms, perceived stress, and marital functioning. These will be measured with the Automatic Thoughts Questionnare (ATQ), the Behavioural Activation Scale for Depression (BADS), the stress subscale of the Depression Anxiety Stress Scale (DASS-21), and the Dyadic Adjustment Scale (DAS-7) respectively.
Timepoint [1] 300795 0
3 months
Secondary outcome [2] 300796 0
Exploratory and descriptive analyses to examine treatment engagement, alliance and satisfaction with the Web-based CBT program and to examine potential baseline predictors of treatment response (in particular, baseline depression severity as measured by the BDI-II).

Session completion, Website usage (including the partner website) and “click-through paths” will be tracked via database flags and analysis of server activity logs. The Working Alliance Inventory (WAI-S) will be completed at 3 month follow-up to measure the strength of alliance with the telephone coach. Satisfaction with each of the main elements of the program will be recorded on a 4-point scale ranging from "Not at all satisfied" to "Very satisfied".
Timepoint [2] 300796 0
3 months

Eligibility
Key inclusion criteria
Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
In order to detect women with PND, we will use networks developed through prior research. Women will be screened for depression with the widely used, well-validated Edinburgh Postnatal Depression Scale (EPDS) during a routine postnatal visit at their Maternal and Child Health Centre. Maternal and Child Health Nurses (MCHNs) will be encouraged to refer women who score above 12 (threshold for probable depression) into the study. In addition, the study will be advertised widely (i.e. Internet, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, beyondblue, etc) will be contacted and encouraged to screen and/or refer women with suspected PND.


Participation will involve completing questionnaires (online, phone, and/or hard copy) at three time points: baseline (enrolment), 9-weeks post-enrolment, and three months post-enrolment. Participation will also involve an assessment interview completed by telephone at enrolment and three months post-enrolment.

Upon receipt of referral, a potential participant will be contacted by a member of the research team. The study will be explained and a preliminary check of whether the woman is likely to meet the eligibility criteria will be made. A cover letter and Participant Information Sheet and Consent Form will then be sent in the mail. Once the woman has read the Participant Information Sheet, had the opportunity to have any questions answered, clearly understands what participation involves and is willing to participate, she will then be asked to sign and return the consent form to the research team using the reply-paid envelope provided.

Eligible, consenting women will be randomly allocated to receive either the Web-based CBT program or the control condition (treatment as usual) ina one-to-one ratio. Allocation will be via centralised administration of a coded, pre-generated allocation schedule (variable-length permuted blocks, computer generated random sequence) prepared by an independent person and administered by another, both blind to coding. Treatment assignment is concealed from telephone coaches and participants until the point of allocation, and from those assessing outcomes and analysing data until follow-up and analysis are finalised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A coded, pre-generated allocation schedule (variable-length permuted blocks, computer generated random sequence) will be prepared by an independent person blind to coding.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous outcomes (e.g., symptom severity) will be analysed with random-effects regression models, accommodating time independent and dependent covariates, fixed and random factors, and incomplete data. Categorical outcomes (e.g., diagnostic status) will be
analysed using contingency tables and logistic regression; survival analysis (Cox regression, Kaplan-Meier product limit) will predict time-to-recovery of the index depressive episode. Consistent with CONSORT standards, (Shulz et al., 2010; Moher et al., 2010) all primary analyses to address our major hypotheses will adhere to intention-to-treat principles and will involve planned contrasts of the coached intervention condition vs. control condition. We will explore baseline and clinical characteristics associated with depression outcomes, acceptability, program usage and usability.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2013
Actual
Date of last participant enrolment
Anticipated
30/12/2013
Actual
14/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286614 0
Charities/Societies/Foundations
Name [1] 286614 0
beyondblue
Country [1] 286614 0
Australia
Funding source category [2] 286621 0
Charities/Societies/Foundations
Name [2] 286621 0
Windermere Foundation
Country [2] 286621 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Parent-Infant Research Institute
Address
Department of Clinical and Health Psychology
Austin Health,
Heidelberg Repatriation Hospital,
300 Waterdale Road,
Heidelberg Heights, Victoria, 3081,
Country
Australia
Secondary sponsor category [1] 285406 0
None
Name [1] 285406 0
Address [1] 285406 0
Country [1] 285406 0
Other collaborator category [1] 277265 0
Individual
Name [1] 277265 0
Dr Brian Danaher
Address [1] 277265 0
Oregon Research Institute,
1776 Millrace Drive
Eugene,
Oregon 97403
Country [1] 277265 0
United States of America
Other collaborator category [2] 277266 0
Individual
Name [2] 277266 0
Dr John Seeley
Address [2] 277266 0
Oregon Research Institute,
1776 Millrace Drive
Eugene,
Oregon 97403
Country [2] 277266 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288687 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 288687 0
Research Ethics Unit,
Henry Buck Building,
Austin Hospital,
145 Studley Road,
Heidelberg,
VIC 3084
Ethics committee country [1] 288687 0
Australia
Date submitted for ethics approval [1] 288687 0
14/05/2012
Approval date [1] 288687 0
30/07/2012
Ethics approval number [1] 288687 0
H2012/04682

Summary
Brief summary
Every year, Postnatal Depression (PND) affects at least 40,000 women in Australia. It has serious consequences for maternal mental health and infant development. Poor uptake of clinic-based treatments suggests a Web-based treatment can play a major role in tackling this public health problem, particularly as an increasing number of women will be identified as depressed through the National Perinatal Depression Initiative. Major barriers to treatment include stigma; poor access; treatment costs, and scheduling trips outside of the home with a new baby. We have developed an interactive, Web-based treatment targeted to women with PND and now aim to evaluate its efficacy comapred to Standard Care in a 2-group randomised controlled trial.

The main aims are to: (a) pilot the efficacy of the program with respect to the primary outcomes of depressive episode remission, and amelioration of depression and anxiety symptoms; and (b) to pilot the efficacy of the MumMoodBooster program with respect to secondary outcomes including the putative CBT change mechanisms, perceived stress, and marital functioning. A total of 50 mothers will be recruited via our well-developed relationship with Maternal and Child Health Centres in Victoria. In addition, the study will be advertised widely, targeting rural women (i.e. Internet e.g. beyondblue, local newspapers, magazines), and appropriate health professionals/services (e.g., GPs, PaNDA, etc) will be contacted and encouraged to screen and/or refer women with suspected PND. Rural is defined as: women in regional, rural, and remote areas outside the CBD (more than 50kms). Women in these areas generally have poorer access to a variety of mental health services. Potential recruits will be screened with the Edinburgh Postnatal Depression Scale (EPDS) and those scoring 13-20, inclusive, on the EPDS will be considered for further involvement. Following referral, women will be contacted by a member of the research team to assess eligibility and explain the study. Inclusion criteria are: (a) EPDS score 13-20, (b) 18 years and older, (c) ability to understand English, (d) 6 weeks to 1 year postpartum, (e) home Internet access, (f) familiarity with the Internet and e-mail, (g) able/willing to give informed consent, (h) diagnosis of a major and minor depressive episode using the Structured Clinical Interview for DSM-IV (SCID). Exclusion criteria are: (a) risk of suicide, (b) current substance abuse, manic/hypomanic symptoms or depression with psychotic features meeting DSM-IV criteria; or c) current treatment for depression (medication or psychotherapy). Following contact with women via phone, a Participant Information and Consent Form will be sent in the mail and potential participants will be asked to sign it and return it to the researchers. A clinical assessment will be completed by phone and participants will be asked to complete the questionnaires by visiting the secure website. Women will be randomised in a 1:1 ratio to Web-based CBT with telephone support (n = 25), or to treatment as usual (n = 25), using a pre-generated permuted blocks allocation schedule. Post-test data will be collected at 9 weeks post-enrolment and follow-up data at three months post-enrolment.
Trial website
Trial related presentations / publications
Danaher, B.G., Milgrom, J., Seeley, J.R., Stuart, S., Schembri, C., Tyler, M.S., Ericksen, J., Lester, W., Gemmill, A.W., Lewinsohn, P. (2012). Web-based Intervention for Postpartum Depression: Formative Research and Design of the MomMoodBooster Program. JMIR Research Protocols, 1(2) e18.
Public notes

Contacts
Principal investigator
Name 37302 0
Prof Jeannette Milgrom
Address 37302 0
Melbourne School of Psychological Sciences, University of Melbourne;
Director, Department of Clinical and Health Psychology and
Parent-Infant Research Institute,
Austin Health,
Address
Heidelberg Repatriation Hospital,
300 Waterdale Road,
Heidelberg Heights, Victoria, 3081,
Australia.
Country 37302 0
Australia
Phone 37302 0
+613 9496 4009
Fax 37302 0
+613 9496 4148
Email 37302 0
[email protected]
Contact person for public queries
Name 37303 0
Alan Gemmill
Address 37303 0
Dr Alan Gemmill
Senior Research Fellow
Parent-Infant Research Institute

Address
Heidelberg Repatriation Hospital,
300 Waterdale Road,
Heidelberg Heights, Victoria, 3081,
Australia.
Country 37303 0
Australia
Phone 37303 0
+613 9496 4468
Fax 37303 0
+613 9496 4148
Email 37303 0
[email protected]
Contact person for scientific queries
Name 37304 0
Alan Gemmill
Address 37304 0
Dr Alan Gemmill
Senior Research Fellow
Parent-Infant Research Institute

Address
Heidelberg Repatriation Hospital,
300 Waterdale Road,
Heidelberg Heights, Victoria, 3081,
Australia.
Country 37304 0
Australia
Phone 37304 0
+613 9496 4468
Fax 37304 0
+613 9496 4148
Email 37304 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseInternet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.2016https://dx.doi.org/10.2196/jmir.4993
N.B. These documents automatically identified may not have been verified by the study sponsor.