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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 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
Sex
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
14/02/2017
Date of last participant enrolment
Anticipated
1/03/2017
Actual
20/02/2017
Date of last data collection
Anticipated
31/03/2017
Actual
12/04/2017
Sample size
Target
10
Accrual to date
Final
2
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
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
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
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1452 1452 0 0
/AnzctrAttachments/372323-Letter - Approved AMENDMENT at HREC Exec Meeting 27 09 2016 - 16 046.pdf (Ethics approval)

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
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
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 Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.