Trial registered on ANZCTR


Trial ID
ACTRN12609001032246
Ethics application status
Approved
Date submitted
7/11/2009
Date registered
30/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Online cognitive behaviour therapy for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial
Scientific title
Online cognitive behaviour therapy (MoodGYM) for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial
Secondary ID [1] 280448 0
Nil
Universal Trial Number (UTN)
Trial acronym

Health condition
Health condition(s) or problem(s) studied:
Postpartum depression 252139 0
Perinatal depression 252140 0
Postnatal depression 252144 0
Condition category
Condition code
Mental Health 252346 252346 0 0
Depression
Reproductive Health and Childbirth 252347 252347 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MoodGYM is an online, interactive program delivering cognitive behaviour therapy. The program consists of five modules which take between 20 and 40 minutes to complete. However, participants can choose to spend as much or as little time as they which in a given session. Module 1: Feelings. Helps participants identify negative thinking patterns. Module 2: Thoughts. Helps people identify inaccurate and biased ways of thinking. Module 3: Unwarping. Helps participants change their negative and biased habitual thinking patterns. Module 4: De-stressing. Provides participants with stress management and relaxation techniques. Module 5: Relationships. To help participants cope with difficult relationships, and the ending of relationships.

Throughout the program, participants also complete depression and anxiety questionnaires with feedback so they may see their progress. Participants complete one module per week at their own pace. Each module must be completed before participants can go on to the next module.
Intervention code [1] 241515 0
Prevention
Comparator / control treatment
The HealthWatch website consists of a series of five, weekly emails directing them to online modules containing general wellbeing information.
Control group
Active

Outcomes
Primary outcome [1] 253217 0
Postnatal distress - Edinburgh Postnatal Depression Scale (EPDS)
Timepoint [1] 253217 0
Baseline, 6 weeks, 6 months, 12 months following randomisation
Primary outcome [2] 253218 0
Clinical diagnosis (depression). Mini International Neuropsychiatric Interview (MINI)
Timepoint [2] 253218 0
Baseline, 12 months following randomisation
Secondary outcome [1] 262157 0
Depressive and anxiety symptomatology - Depression, Anxiety and Stress Scale (DASS-21)
Timepoint [1] 262157 0
Baseline, 6 weeks, 6 months, 12 months following randomisation
Secondary outcome [2] 262158 0
Parenting confidence - Karitane Parenting Confidence Scale (KPCS)
Timepoint [2] 262158 0
Baseline, 6 weeks, 6 months, 12 months following randomisation

Eligibility
Key inclusion criteria
Have internet access, have an email address, have a telephone number, have had a live birth, are fluent in English, have an Edinburgh Postnatal Depression Scale score of over 9.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently receiving psychological treatment, current depressive disorder, or lifetime bipolar or psychotic disorders - Mini International Neuropsychiatric Interview (MINI)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A random number sequence will be matched with usernames prior to participant enrolment without the knowledge of the enrolling researcher. Enrolled participants will be allocated usernames enabling the enrolling researcher to remain blind to participant condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to condition using a computer-generated algorithm that is replicable and validated. The start value for the seed will be determined from the current server time and will be recorded for replication. Randomisation will not be stratified, however a varying block size will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Anticipated date of first participant enrolment
1/06/2012
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
175
Actual sample size
Recruitment status
Not yet recruiting
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2345 0
2605

Funding & Sponsors
Funding source category [1] 243990 0
Self funded/Unfunded
Name [1] 243990 0
Address [1] 243990 0
Country [1] 243990 0
Primary sponsor type
University
Name
Centre for Mental Health Research
Address
Building 63
Eggleston Road
The Australian National University ACT 0200
Country
Australia
Secondary sponsor category [1] 251342 0
None
Name [1] 251342 0
Address [1] 251342 0
Country [1] 251342 0
Other collaborator category [1] 942 0
Individual
Name [1] 942 0
Professor Kathy Griffiths
Address [1] 942 0
Building 63
Eggleston Road
The Australian National University ACT 0200
Country [1] 942 0
Australia
Other collaborator category [2] 943 0
Individual
Name [2] 943 0
Professor Helen Christensen
Address [2] 943 0
Building 63
Eggleston Road
The Australian National University ACT 0200
Country [2] 943 0
Australia
Other collaborator category [3] 944 0
Individual
Name [3] 944 0
Professor David Ellwood
Address [3] 944 0
The Australian National University Medical School,
School of Clinical Medicine, The Canberra Hospital, PO Box 11, Woden, ACT 2606
Country [3] 944 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244095 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 244095 0
ACT Health HREC
Building 10 Level 6
Canberra Hospital
Garran ACT 2605
Ethics committee country [1] 244095 0
Australia
Date submitted for ethics approval [1] 244095 0
01/02/2010
Approval date [1] 244095 0
20/04/2012
Ethics approval number [1] 244095 0
ETH.9.11.231

Summary
Brief summary
The current project is a randomised controlled trial of online cognitive behaviour therapy (MoodGYM) to prevent postnatal depression in at-risk women. To date, there have not been broad scale, cost-effective prevention programs for postnatal depression that have been effective. While the MoodGYM is effective in the wider community, it has never been used in a postnatal population. Although women will need an internet connection to access MoodGYM, major barriers, such as childcare, lack of time, stigma and low clinician availability are all overcome with this intervention. The prevention of postnatal depression in a way that is acceptable to mothers could have the potential to reduce the burden of the most common complication of the perinatal period. Prevention of this illness will result in better outcomes, not just for mothers, but for their infants and families as well.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30476 0
Address 30476 0
Country 30476 0
Phone 30476 0
Fax 30476 0
Email 30476 0
Contact person for public queries
Name 13723 0
Bethany Jones
Address 13723 0
Building 63
Eggleston Road
The Australian National University ACT 0200
Country 13723 0
Australia
Phone 13723 0
+61 433 167 919
Fax 13723 0
Email 13723 0
bethany.jones@anu.edu.au
Contact person for scientific queries
Name 4651 0
Bethany Jones
Address 4651 0
Building 63
Eggleston Road
The Australian National University ACT 0200
Country 4651 0
Australia
Phone 4651 0
+61 433 167 919
Fax 4651 0
Email 4651 0
bethany.jones@anu.edu.au