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Trial registered on ANZCTR


Registration number
ACTRN12617000289314
Ethics application status
Approved
Date submitted
14/02/2017
Date registered
24/02/2017
Date last updated
2/05/2019
Date data sharing statement initially provided
2/05/2019
Date results information initially provided
2/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Pilot Trial evaluating the impact of internet-delivered cognitive behavioural therapy (iCBT) program on symptoms of postnatal anxiety and depression: Study 3: The Perinatal MUMentum Program: Postpartum Pilot
Scientific title
A Pilot Trial evaluating the impact of internet-delivered cognitive behavioural therapy (iCBT) program on symptoms of postnatal anxiety and depression: Study 3: The Perinatal MUMentum Program: Postpartum Pilot
Secondary ID [1] 291133 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety during the postpartum period (up to 12 months after childbirth) 301960 0
Depression during the postpartum period (up to 12 months after childbirth) 301961 0
Condition category
Condition code
Mental Health 301612 301612 0 0
Anxiety
Mental Health 301613 301613 0 0
Depression
Reproductive Health and Childbirth 301614 301614 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This Pilot Trial aims to evaluate the impact of internet-delivered cognitive behavioural therapy (iCBT) program on symptoms of postnatal anxiety and depression.

The internet-based intervention program 3 consists of a 3-lesson iCBT postpartum course. The course is completed over a 4-week period, with one lesson released per week (every 7 days) for the first 3 weeks. The course describes the experiences of two fictional female characters who learn to recognise and manage their symptoms of anxiety and depression by using cognitive and behavioural skills and principles. Each lesson will take approximately 45-60 minutes to complete and contains an illustrated lesson, a lesson summary with practical exercises and activities, and extra resources. Participants are encouraged to spend 3-4 hours per week reviewing the lesson content and implementing the practical skills and exercises. Participants are not required to complete all components of the lesson at once, but are required to view the illustrated lesson online and download the lesson summary in order to proceed with the program. If the participant is slightly behind the lesson release timetable (i.e accesses the first lesson on Day 8, although Lesson 2 became available on Day 7 - they would then have to wait 5 days in order to access Lesson 2). If a participant access the lesson on the day it is released (i.e Day 1, Day 7, Day 14) then there would be a 7-day gap between lesson. The gap between lessons is to ensure participants spend enough time completing each lesson before moving on. Automated emails are sent to participants if they have not accessed or completed the lesson. Automated notification emails are also sent to participants when the next lesson is available.
Intervention code [1] 297113 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301011 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [1] 301011 0
Post-treatment (Week 5)
Primary outcome [2] 301012 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 301012 0
Post-treatment (Week 5)
Secondary outcome [1] 331456 0
Perinatal depression: Changes in scores from baseline on the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [1] 331456 0
Post-treatment (Week 5)
Secondary outcome [2] 331458 0
General psychological distress severity: Changes in scores from baseline on the Kessler 10-item scale (K-10).
Timepoint [2] 331458 0
Post-treatment (Week 5)
Secondary outcome [3] 331459 0
Participant satisfaction with the intervention program on the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [3] 331459 0
Post-treatment (Week 5)
Secondary outcome [4] 331724 0
Experiences + Perceptions Questionnaire (EPQ)
Timepoint [4] 331724 0
Post-treatment (Week 5)

Eligibility
Key inclusion criteria
Women who are currently in the postpartum period (up to 12 months after childbirth) and whose online self-report questionnaire scores indicate a clinical level of anxiety (GAD-7 >9) and/or depression (PHQ-9 >9) will be included in this study. Participants must also:
- Live in Australia
- 18 years of age or older
- Fluent in written and spoken English
- Have a computer with internet access, up to date browser, and printer
- Willing to provide the name and contact details of their general practitioner
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they do not live in Australia, are under 18 years of age at application, are not fluent in written and spoken English, and do not have a computer with internet access, up to date browser, and printer.

Participants who self-report a diagnosis of a psychotic mental illness (Bipolar, Schizophrenia), substance abuse or dependence, severe depression (PHQ-9 score of >20), or current suicidality will also be excluded.

Participants that do not provide their GP contact details at application will also be excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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
Recruitment hospital [1] 7449 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 7452 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 15276 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 15279 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 295571 0
Charities/Societies/Foundations
Name [1] 295571 0
HCF Research Foundation
Address [1] 295571 0
GPO Box 4242
Sydney NSW 2001
Country [1] 295571 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 294397 0
None
Name [1] 294397 0
Address [1] 294397 0
Country [1] 294397 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296891 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 296891 0
St Vincent's Hospital Research Office
Level 6, de Lacy Building
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 296891 0
Australia
Date submitted for ethics approval [1] 296891 0
07/03/2016
Approval date [1] 296891 0
21/04/2016
Ethics approval number [1] 296891 0
HREC/16/SVH/63

Summary
Brief summary
Anxiety and depression are common in the perinatal period (i.e. during pregnancy and the first year after childbirth). Postnatal depression and anxiety disorders affect around 15% of women, with up to 45% of cases beginning in pregnancy (e.g., Austin et al., 2010).

Early evidence shows that iCBT is effective for reducing postnatal depression, anxiety, general distress and parental distress (Danaher et al., 2013; Pugh, Hadjistavropoulos, & Dirkse, in press). Tailored iCBT programs are needed to provide women in the perinatal period with practical coping skills to manage depression and anxiety symptoms, as well as deal with the unique difficulties they may face which can impact on depression and anxiety (e.g. complications during pregnancy and/or delivery, body image, difficulty breastfeeding, an unsettled baby, and unrealistic expectations about motherhood).

The primary purpose of this pilot trial is to evaluate and gather feasibility of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. Postpartum Pilot will be conducted as a feasibility exercise to get feedback and evaluation on the efficacy and acceptability of an iCBT program tailored to maternal anxiety and depression experienced during the postpartum period, prior to commencing a larger randomised trial.

The main hypothesis to be tested for Postpartum Pilot is as follows:

1. Internet cognitive behavioural therapy delivered during the postpartum period will significantly reduce symptoms of anxiety, depression, distress and disability.

It is hoped that the findings of this trial will provide further information regarding the efficacy and acceptability of the Perinatal MUMentum Program- in reducing maternal anxiety and depression experienced during the perinatal period- before embarking on a larger RCT.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 72350 0
Prof Gavin Andrews
Address 72350 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 72350 0
Australia
Phone 72350 0
+61 2 8382 1400
Fax 72350 0
+61 2 8382 1401
Email 72350 0
gavina@unsw.edu.au
Contact person for public queries
Name 72351 0
Miss Siobhan Loughnan
Address 72351 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 72351 0
Australia
Phone 72351 0
+61 2 8382 1434
Fax 72351 0
+61 2 8382 1401
Email 72351 0
Siobhan.Loughnan@svha.org.au
Contact person for scientific queries
Name 72352 0
Miss Siobhan Loughnan
Address 72352 0
Clinical Research Unit for Anxiety and Depression (CRUfAD)
4, The O'Brien Centre, St Vincent's Hospital, 394-404 Victoria St, Darlinghurst NSW 2010
Country 72352 0
Australia
Phone 72352 0
+61 2 8382 1434
Fax 72352 0
+61 2 8382 1401
Email 72352 0
Siobhan.Loughnan@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant privacy and data sharing as agreed upon in consent form.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Two participants completed the ‘MUMentum Postnatal’ program in this pilot study. Outcome data was not analysed as this pilot study aimed to test the functionality of the online software only.