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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000289314
Enrollment
2
Registered
2017-02-24
Start date
2017-02-14
Completion date
2017-02-20
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 anxiet

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.

Sponsors

St Vincent's Hospital, Sydney
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026