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

Not Applicable

Completed

• Conditions: Anxiety during the postpartum period (up to 12 months after childbirth); Depression during the postpartum period (up to 12 months after childbirth); Mental Health - Anxiety; Mental Health - Depression; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12616000559415
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief 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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-02
• Study Completion: 2019-03-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 132

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 >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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety severity: Change in scores from baseline on the Generalised Anxiety Disorder 7-point scale (GAD-7).[Post-treatment (Week 5)];Depression severity: Change in scores from baseline on the Patient Health Questionnaire (PHQ-9).[Post-treatment (Week 5)]