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Trial registered on ANZCTR


Registration number
ACTRN12613000881730
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
7/08/2013
Date last updated
7/08/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Web-based Cognitive Behavioural Therapy for Women With Postnatal Depression: A Comparison with Face-to-Face Therapy
Scientific title
A randomised controlled trial of a web-based versus face-to-face cognitive behavioural therapy for the treatment of clinical depression in postnatal women
Secondary ID [1] 282937 0
Nil Known
Universal Trial Number (UTN)
None
Trial acronym
MMB (MumMoodBooster)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postnatal depression 289754 0
postnatal anxiety 289755 0
Condition category
Condition code
Mental Health 290092 290092 0 0
Depression
Mental Health 290093 290093 0 0
Anxiety
Reproductive Health and Childbirth 290094 290094 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1] 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.

2] Face-to-face CBT: Women in this condition will receive weekly individual CBT therapy (approximately 1 hour session) with an experienced psychologist using an individualised version of our Getting Ahead of Postnatal Depression program. Within the 9-week program a detailed manual is followed that includes 9 sessions with each woman (Milgrom et al., 1999). The program uses a CBT approach and addresses maternal mood (depression and anxiety), behavioural activation, cognitive strategies, self-esteem, relaxation (“relax on the run”), getting support and dealing with partner issues.

In the Web-based intervention adherence to treatment (completion of modules) will be monitored online and via telephone coaching calls. In the face-to-face CBT group, therapists will follow a manualised protocol and will keep detailed session attendance records including details of content covered in each weekly (1 hour) session.
Intervention code [1] 287639 0
Treatment: Other
Intervention code [2] 287640 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] 290133 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 post-treatment
Timepoint [1] 290133 0
3 months post-treatment
Primary outcome [2] 290134 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] 290134 0
3 months post-treatment
Secondary outcome [1] 304000 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] 304000 0
3 months post-treatment
Secondary outcome [2] 304001 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] 304001 0
3 months post-treatment

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
Gender
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. An alternative online pre-screening and consent process will also be available. 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-treatment. Participation will also involve an assessment interview completed by telephone at enrolment and three months post-treatment. 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. Alternatively, women will be able to complete an online pre-screening eligibility and consent process. Once baseline measures are secured, eligible, consenting women will be randomly allocated to receive either Web-based or face-to-face CBT, or to the control condition (treatment as usual) in a 1:1:1 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
Not Applicable
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.

Clinical Significance, Power and Sample Size: For the survival analysis predicting time-to-remission from the index episode, with a 2-tailed alpha of .05, n = 70 per condition yields 80% power to detect a small effect size (hazard ratio of 2.0). For the measure of depressive symptoms (BDI), data in Milgrom et al. (2005b) provide a baseline value = 23, SD = 8.09. A difference of 6.5 takes scores below the threshold of ‘clinical’ depression (i.e. a score below 17 points). With 80% power at alpha = 0.05, the required n = 15.7(8.09/6.5)2 = 24.3, which rounds to 25. With a prudent non-compliance rate of 30%: n* = 25/(1-0.3)2 = 51, which rounds to 55. Thus, n = 70 per condition yields sufficient power to detect a small between-groups effect size and a clinically significant difference in the primary outcomes.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 287712 0
Government body
Name [1] 287712 0
National Health & Medical Research Council (NHMRC)
Address [1] 287712 0
GPO Box 1421
Canberra ACT 2601
Country [1] 287712 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] 286441 0
None
Name [1] 286441 0
Address [1] 286441 0
Country [1] 286441 0
Other collaborator category [1] 277551 0
Individual
Name [1] 277551 0
Dr Brian Danaher
Address [1] 277551 0
Oregon Research Institute, 1776 Millrace Drive Eugene, Oregon 97403
Country [1] 277551 0
United States of America
Other collaborator category [2] 277552 0
Individual
Name [2] 277552 0
Dr John Seeley
Address [2] 277552 0
Oregon Research Institute, 1776 Millrace Drive Eugene, Oregon 97403
Country [2] 277552 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289668 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 289668 0
Human Research Ethics Committee
Office for Research, Level 6 HSB.
Austin Hospital
154 Studley Road
PO Box 5555 Heidelberg
VIC 3084
Ethics committee country [1] 289668 0
Australia
Date submitted for ethics approval [1] 289668 0
Approval date [1] 289668 0
11/06/2013
Ethics approval number [1] 289668 0
H2013 / 04972

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 compared to traditional face-to-face cognitive behavioural therapy in a 3-group randomised controlled trial. The main aims are to: (a) evaluate 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 evaluate 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 210 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 (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. 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 or will complete pre-screening measures online. 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. An alternative online pre-screening and consent process is also in place. A clinical assessment will then be completed by phone and participants will be asked to complete baseline, pre-treatment questionnaires by visiting the secure website. Women will then be randomised in a 1:1:1 ratio to Web-based or face-to-face CBT (n = 70 in each), or to treatment as usual (n = 70), 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-treatment.
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 41790 0
Prof Jeannette Milgrom
Address 41790 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 41790 0
Australia
Phone 41790 0
+613 9496 4009
Fax 41790 0
613 9496 4148
Email 41790 0
jeannette.milgrom@austin.org.au
Contact person for public queries
Name 41791 0
Dr Alan Gemmill
Address 41791 0
Dr Alan Gemmill,
Senior Research Fellow,
Parent-Infant Research Institute, Heidelberg Repatriation Hospital, 300 Waterdale Road, Heidelberg Heights, Victoria, 3081, Australia
Country 41791 0
Australia
Phone 41791 0
+613 9496 4468
Fax 41791 0
+613 9496 4148
Email 41791 0
alan.gemmill@austin.org.au
Contact person for scientific queries
Name 41792 0
Dr Alan Gemmill
Address 41792 0
Dr Alan Gemmill,
Senior Research Fellow,
Parent-Infant Research Institute, Heidelberg Repatriation Hospital, 300 Waterdale Road, Heidelberg Heights, Victoria, 3081, Australia
Country 41792 0
Australia
Phone 41792 0
+613 9496 4468
Fax 41792 0
+613 9496 4148
Email 41792 0
alan.gemmill@austin.org.au

No information has been provided regarding IPD availability
Summary results
No Results