Trial from ANZCTR


Trial ID ACTRN12609001032246
Trial Status: Registered
Date Submitted: 7/11/2009
Date Registered: 30/11/2009
Prospectively registered

Page 1

Public title Online cognitive behaviour therapy for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Online cognitive behaviour therapy (MoodGYM) for the prevention of postnatal depression in at-risk mothers: a randomised controlled trial
Update:
 
Reason:
 
Secondary ID [1] 280448 0
Nil
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Prevention 241515 0
Update:
 
Reason:
 
Comparator / control treatment The HealthWatch website consists of a series of five, weekly emails directing them to online modules containing general wellbeing information.
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

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

Page 5

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.
Update:
 
Reason:
 
Minimum age 18 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age No limit
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Females
Update:
 
Reason:
 
Healthy volunteers? Yes
Update:
 
Reason:
 
Key exclusion criteria Currently receiving psychological treatment, current depressive disorder, or lifetime bipolar or psychotic disorders - Mini International Neuropsychiatric Interview (MINI)
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Prevention
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Describe the 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.
Update:
 
Reason:
 
Masking / blinding Blinded (masking used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Not Applicable
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/06/2012
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 175
Update:
 
Reason:
 
Recruitment status Not yet recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 
Postcode: 2605 2345 0
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Self funded/Unfunded 243990 0
Update:
 
Reason:
 
Name: 243990 0
Update:
 
Reason:
 
Address: 243990 0
Update:
 
Reason:
 
Country: 243990 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: Centre for Mental Health Research
Update:
 
Reason:
 
Address: Building 63
Eggleston Road
The Australian National University ACT 0200
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: None 251342 0
Update:
 
Reason:
 
Name: 251342 0
Update:
 
Reason:
 
Address: 251342 0
Update:
 
Reason:
 
Country: 251342 0
Update:
 
Reason:
 
Other Collaborator: Individual 942 0
Update:
 
Reason:
 
Name: Professor Kathy Griffiths 942 0
Update:
 
Reason:
 
Address: Building 63
Eggleston Road
The Australian National University ACT 0200
942 0
Update:
 
Reason:
 
Country: Australia 942 0
Update:
 
Reason:
 
Other Collaborator: Individual 943 0
Update:
 
Reason:
 
Name: Professor Helen Christensen 943 0
Update:
 
Reason:
 
Address: Building 63
Eggleston Road
The Australian National University ACT 0200
943 0
Update:
 
Reason:
 
Country: Australia 943 0
Update:
 
Reason:
 
Other Collaborator: Individual 944 0
Update:
 
Reason:
 
Name: Professor David Ellwood 944 0
Update:
 
Reason:
 
Address: The Australian National University Medical School,
School of Clinical Medicine, The Canberra Hospital, PO Box 11, Woden, ACT 2606
944 0
Update:
 
Reason:
 
Country: Australia 944 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
Ethics Committee name: ACT Health Human Research Ethics Committee 244095 0
Update:
 
Reason:
 
Address: ACT Health HREC
Building 10 Level 6
Canberra Hospital
Garran ACT 2605
244095 0
Update:
 
Reason:
 
Country: Australia 244095 0
Update:
 
Reason:
 
Approval Date: 20/04/2012 244095 0
Update:
 
Reason:
 
Submitted Date: 01/02/2010 244095 0
Update:
 
Reason:
 
HREC: ETH.9.11.231 244095 0
Update:
 
Reason:
 
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.
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
30476 0
Name:
Update:
 
Reason:
 
30476 0
Address:
Update:
 
Reason:
 
30476 0
Country:
Update:
 
30476 0
Reason:
 
Tel:
Update:
 
Reason:
 
30476 0
Fax:
Update:
 
Reason:
 
30476 0
Email:
Update:
 
Reason:
 
30476 0
Contact person for public queries
Title:
Update:
 
Reason:
 
13723 0
Name: Bethany Jones
Update:
 
Reason:
 
13723 0
Address: Building 63 Eggleston Road The Australian National University ACT 0200
Update:
 
Reason:
 
13723 0
Country: Australia
Update:
 
13723 0
Reason:
 
Tel: +61 433 167 919
Update:
 
Reason:
 
13723 0
Fax:
Update:
 
Reason:
 
13723 0
Email: bethany.jones@anu.edu.au
Update:
 
Reason:
 
13723 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
4651 0
Name: Bethany Jones
Update:
 
Reason:
 
4651 0
Address: Building 63 Eggleston Road The Australian National University ACT 0200
Update:
 
Reason:
 
4651 0
Country: Australia
Update:
 
4651 0
Reason:
 
Tel: +61 433 167 919
Update:
 
Reason:
 
4651 0
Fax:
Update:
 
Reason:
 
4651 0
Email: bethany.jones@anu.edu.au
Update:
 
Reason:
 
4651 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
22795 0
Name: Bethany Jones
Update:
 
Reason:
 
22795 0
Address: Building 63 Eggleston Road The Australian National University ACT 0200
Update:
 
Reason:
 
22795 0
Country: Australia
Update:
 
22795 0
Reason:
 
Tel: +61 433 167 919
Update:
 
Reason:
 
22795 0
Fax:
Update:
 
Reason:
 
22795 0
Email: bethany.jones@anu.edu.au
Update:
 
Reason:
 
22795 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: