ANZCTR - Registration

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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 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

Secondary ID [1]

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)

Depression during the postpartum period (up to 12 months after childbirth)

Condition category

Condition code

Mental Health

Anxiety

Mental Health

Depression

Reproductive Health and Childbirth

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]

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]

Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).

Timepoint [1]

Post-treatment (Week 5)

Primary outcome [2]

Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).

Timepoint [2]

Post-treatment (Week 5)

Secondary outcome [1]

Pathological worry severity: Changes in scores from baseline on the Penn State Worry Questionnaire (PSWQ)

Timepoint [1]