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Trial registered on ANZCTR


Registration number
ACTRN12616000559415
Ethics application status
Approved
Date submitted
28/04/2016
Date registered
2/05/2016
Date last updated
14/05/2019
Date data sharing statement initially provided
14/05/2019
Date results information initially provided
14/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the clinical efficacy of internet-delivered cognitive behavioural therapy for perinatal anxiety and depression to treatment as usual.
Study 2: The Perinatal MUMentum Program: Postpartum Course
Scientific title
A randomised controlled trial comparing the clinical efficacy of internet-delivered cognitive behavioural therapy for perinatal anxiety and depression to treatment as usual.
Study 2: The Perinatal MUMentum Program: Postpartum Course
Secondary ID [1] 289095 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) 298554 0
Depression during the postpartum period (up to 12 months after childbirth) 298555 0
Condition category
Condition code
Mental Health 298638 298638 0 0
Anxiety
Mental Health 298639 298639 0 0
Depression
Reproductive Health and Childbirth 298640 298640 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a randomised controlled trial comparing the clinical efficacy of an internet-based cognitive behavioural therapy (iCBT) program for maternal anxiety and/or depression during the postpartum period versus treatment as usual (TAU) control. Individuals will apply for Study 2 if they are currently in the postpartum period (i.e. up to 12 months after childbirth). Participants will be randomly allocated to Group 1 or Group 2, Group 1 will receive a 4-week iCBT intervention program (The Perinatal MUMentum Program: Postpartum Course), while Group 2 will participate in a 9-week waiting period before gaining access to the program.

Group 1: The internet-based intervention program for Study 2 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. There is a 5-day waiting period between lessons to ensure participants spend enough time completing each lesson before moving on. Adherence and time spent per lesson is monitored by computer software, with automated emails 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 (5 days after completion of previous lesson).
Intervention code [1] 294602 0
Treatment: Other
Comparator / control treatment
All participants randomised to the control group (TAU) will receive usual care with their GP or perinatal health practitioner. Over the 9-week waiting period, participants will be required to complete 3 sets of online questionnaires, which enquire about their mental health (e.g. anxiety, depression, stress etc.). At conclusion of the 9-week waiting period, participants will be offered access to the Perinatal MUMentum Program via a secure website (which includes both the pregnancy and postpartum course materials and resources).
Control group
Active

Outcomes
Primary outcome [1] 298132 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [1] 298132 0
Post-treatment (Week 5)
Primary outcome [2] 298133 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 298133 0
Post-treatment (Week 5)
Secondary outcome [1] 323244 0
Pathological worry severity: Changes in scores from baseline on the Penn State Worry Questionnaire (PSWQ)
Timepoint [1] 323244 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [2] 323245 0
Perinatal anxiety: Changes in scores from baseline on the Perinatal Anxiety Screening Scale (PASS).
Timepoint [2] 323245 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [3] 323246 0
Perinatal depression: Changes in scores from baseline on the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [3] 323246 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [4] 323247 0
General psychological distress severity: Changes in scores from baseline on the Kessler 10-item scale (K-10).
Timepoint [4] 323247 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [5] 323248 0
Participant satisfaction with the intervention program on the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [5] 323248 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [6] 323249 0
Functional impairment/disability: Changes in scores from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS-II).
Timepoint [6] 323249 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [7] 323250 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [7] 323250 0
1-month follow-up; 12-month follow-up.
Secondary outcome [8] 323251 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [8] 323251 0
1-month follow-up; 12-month follow-up.

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 >23), or current suicidality will also be excluded.

Women who self-report an infant born less than 37 weeks gestation and/or infant with congenital abnormalities will 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated online by computer generated software to either Group 1 (iCBT) or Group 2 (TAU). Allocation will be generated through the use of computer software by an independent member of the research team, and will be concealed from the study investigators, with the number sequence uploaded by an independent IT staff member.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated via www.random.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculation: A pre-to-post-treatment improvement of effect size (ES) 1.0 is expected for the iCBT treatment group on the primary measures (PHQ-9; GAD-7). This group is also expected to improve more than the treatment as usual (TAU) control group by an ES of 0.8. Assuming an ES > 0.8, power at 80%, and alpha set at .05, a sample size of 25 per group is needed to detect a between-groups effect size difference of 0.8. A sample of N=80 will allow for attrition.

Analysis Plan: All analyses will be undertaken using intention to treat mixed model and linear analyses. Relationships between observations at different occasions will be modelled with the appropriate covariance matrix. Planned contrasts will be used to compare changes between pre-treatment and post-treatment, and 1-month and 12-month follow-ups. Planned pairwise comparisons will be used to compare between-groups at post-treatment, and follow-up and effect sizes will be calculated (Hedges g) to measure the size of the between-groups difference on primary and secondary outcome measures.

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] 5696 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 5697 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 13182 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 13183 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293469 0
Charities/Societies/Foundations
Name [1] 293469 0
HCF Research Foundation
Address [1] 293469 0
GPO Box 4242
Sydney NSW 2001
Country [1] 293469 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] 292292 0
None
Name [1] 292292 0
Address [1] 292292 0
Country [1] 292292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294911 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 294911 0
St Vincent's Hospital Research Office
Level 6, de Lacy Building
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 294911 0
Australia
Date submitted for ethics approval [1] 294911 0
07/03/2016
Approval date [1] 294911 0
21/04/2016
Ethics approval number [1] 294911 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 trial is to evaluate the clinical efficacy of a newly developed internet-delivered cognitive behaviour therapy (iCBT) program, the Perinatal MUMentum Program. This iCBT program has been tailored to maternal anxiety and depression experienced during the perinatal period. The MUMentum Program consists of two 3-lesson courses: Pregnancy and Postpartum. The courses can be completed separately or in conjunction with each other and have been designed in consideration of several key issues experienced during the perinatal period when seeking and completing treatment, including a lack of time, fatigue, and stigma.

The main hypotheses to be tested for Study 2 (Postpartum Course) are as follows:
1. Internet cognitive behavioural therapy delivered during the postpartum period will significantly reduce symptoms of anxiety, depression, distress and disability.
2. Internet cognitive behavioural therapy delivered during the postpartum period will be significantly more effective than the control group at reducing 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.
Trial website
www.virtualclinic.org.au
Trial related presentations / publications
Nil as yet
Public notes

Contacts
Principal investigator
Name 65446 0
Prof Gavin Andrews
Address 65446 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 65446 0
Australia
Phone 65446 0
+61 2 8382 1400
Fax 65446 0
+61 2 8382 1401
Email 65446 0
gavina@unsw.edu.au
Contact person for public queries
Name 65447 0
Miss Siobhan Loughnan
Address 65447 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 65447 0
Australia
Phone 65447 0
+61 2 8382 1434
Fax 65447 0
+61 2 8382 1401
Email 65447 0
Siobhan.Loughnan@svha.org.au
Contact person for scientific queries
Name 65448 0
Miss Siobhan Loughnan
Address 65448 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 65448 0
Australia
Phone 65448 0
+61 2 8382 1434
Fax 65448 0
+61 2 8382 1401
Email 65448 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 the 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?
Yes
Journal publication details
Publication date and citation/details [1] 1979 0
Loughnan, S. A., Butler, C., Sie, A. A., Grierson, A. B., Chen, A. Z., Hobbs, M. J., ... & Gemmill, A. W. (2019). A randomised controlled trial of'MUMentum postnatal': Internet-delivered cognitive behavioural therapy for anxiety and depression in postpartum women. Behaviour research and therapy, 116, 94.
Attachments [1] 1979 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
A total of 131 Australian postpartum women were recruited for this RCT, with 69 randomised to the intervention group (iCBT) and 62 to the control group (TAU). Of these, 46 of 62 women completed the iCBT program and reported high rates of satisfaction. Analyses indicated moderate to large between-group superiority of iCBT over TAU at post-treatment for anxiety, depression, psychological distress, maternal bonding, and quality of life , with gains maintained at follow-up in the iCBT group. After treatment, 63% and 79% of women demonstrated scores below clinical threshold for anxiety and depression, respectively. In contrast, only 42% of the control group had scores below clinical threshold. This study provides preliminary evidence of brief, unguided iCBT for the treatment of postpartum anxiety and depression and has significant implications for increasing treatment accessibility.