None listed
Conditions
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.
Interventions
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 w
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).
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
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 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
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.
Outcome results
None listed