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Trial registered on ANZCTR


Registration number
ACTRN12616000560493
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 1: The Perinatal MUMentum Program: Pregnancy 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 1: The Perinatal MUMentum Program: Pregnancy Course
Secondary ID [1] 289087 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety during pregnancy
 298546 0
Depression during pregnancy 298547 0
Condition category
Condition code
Mental Health 298628 298628 0 0
Anxiety
Mental Health 298629 298629 0 0
Depression
Reproductive Health and Childbirth 298637 298637 0 0
Antenatal 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 pregnancy versus treatment as usual (TAU) control. Individuals will apply for Study 1 if they are currently pregnant (<30 weeks). Participants will be randomly allocated to Group 1 or Group 2, Group 1 will receive a 4-week intervention program (The Perinatal MUMentum Program: Pregnancy 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 1 consists of a 3-lesson iCBT pregnancy course. The course is completed over a 4-week period, with one lesson released per week (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] 294597 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] 298123 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [1] 298123 0
Post-treatment (Week 5)
Primary outcome [2] 298124 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 298124 0
Post-treatment (Week 5)
Secondary outcome [1] 323229 0
Pathological worry severity: Changes in scores from baseline on the Penn State Worry Questionnaire (PSWQ)
Timepoint [1] 323229 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [2] 323232 0
Perinatal anxiety: Changes in scores from baseline on the Perinatal Anxiety Screening Scale (PASS).
Timepoint [2] 323232 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [3] 323233 0
Perinatal depression: Changes in scores from baseline on the Edinburgh Postnatal Depression Scale (EPDS).
Timepoint [3] 323233 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [4] 323234 0
General psychological distress severity: Changes in scores from baseline on the Kessler 10-item scale (K-10).
Timepoint [4] 323234 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [5] 323235 0
Participant satisfaction with the intervention program on the Credibility/Expectancy Questionnaire (CEQ)
Timepoint [5] 323235 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [6] 323236 0
Functional impairment/disability: Changes in scores from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS-II).
Timepoint [6] 323236 0
Post-treatment (Week 5); 1-month follow-up; 12-month follow-up.
Secondary outcome [7] 323237 0
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).
Timepoint [7] 323237 0
1-month follow-up; 12-month follow-up.
Secondary outcome [8] 323238 0
Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).
Timepoint [8] 323238 0
1-month follow-up; 12-month follow-up.

Eligibility
Key inclusion criteria
Women who are currently pregnant (<30 weeks) 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 >23), or current suicidality will also be excluded.

Women who are more than 30 weeks pregnant will be excluded, as will participants that report a medically high-risk pregnancy. 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 or Group 2. 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
31/08/2016
Actual
17/10/2016
Date of last participant enrolment
Anticipated
31/07/2017
Actual
20/09/2017
Date of last data collection
Anticipated
20/11/2018
Actual
24/09/2018
Sample size
Target
80
Accrual to date
Final
87
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 5690 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 5691 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 13177 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 13178 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 293465 0
Charities/Societies/Foundations
Name [1] 293465 0
HCF Research Foundation
Country [1] 293465 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] 292287 0
None
Name [1] 292287 0
Address [1] 292287 0
Country [1] 292287 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294906 0
St Vincent's Hospital HREC (EC00140)
Ethics committee address [1] 294906 0
St Vincent's Hospital Research Office
Level 6, de Lacy Building
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 294906 0
Australia
Date submitted for ethics approval [1] 294906 0
07/03/2016
Approval date [1] 294906 0
21/04/2016
Ethics approval number [1] 294906 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 1 (Pregnancy Course) are as follows:
1. Internet cognitive behavioural therapy delivered during pregnancy will significantly reduce symptoms of anxiety, depression, distress and disability.
2. Internet cognitive behavioural therapy delivered during pregnancy 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
Attachments [1] 861 861 0 0
/AnzctrAttachments/370591-Letter - HREC FINAL approval at HREC Exec meeting 19 04 2016 OOS - 16 046.pdf

Contacts
Principal investigator
Name 65422 0
Prof Gavin Andrews
Address 65422 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 65422 0
Australia
Phone 65422 0
+61 2 8382 1400
Fax 65422 0
+61 2 8382 1401
Email 65422 0
[email protected]
Contact person for public queries
Name 65423 0
Siobhan Loughnan
Address 65423 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 65423 0
Australia
Phone 65423 0
+61 2 8382 1434
Fax 65423 0
+61 2 8382 1401
Email 65423 0
[email protected]
Contact person for scientific queries
Name 65424 0
Siobhan Loughnan
Address 65424 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 65424 0
Australia
Phone 65424 0
+61 2 8382 1434
Fax 65424 0
+61 2 8382 1401
Email 65424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Privacy of participant data as stated in original consent form.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Loughnan, S. A., Sie, A., Hobbs, M. J., Joubert, A... [More Details]
Plain language summaryNo A total of 87 Australian women participated in thi... [More Details]

Documents added automatically
No additional documents have been identified.