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

Not Applicable

Completed

• Conditions: Anxiety during pregnancy; Depression during pregnancy; Mental Health - Anxiety; Mental Health - Depression; Reproductive Health and Childbirth - Antenatal care

• Registration Number: ACTRN12616000560493
• Lead Sponsor: St Vincent's Hospital, Sydney

Brief Summary

A total of 87 Australian women participated in this RCT with 43 randomly allocated to the iCBT intervention and 44 to the control condition. Of the 36 women who started iCBT, 26 completed all three lessons of treatment. iCBT produced moderate to large effect size reductions for anxiety and psychological distress that were superior to TAU. Only small nonsignificant differences were found for depression outcomes. Participants reported that iCBT was an acceptable treatment for antenatal anxiety and/or depression. This is the first study to evaluate brief unguided iCBT for antenatal anxiety and depression. While our findings are promising, particularly for anxiety reduction, additional RCTs are required to establish treatment efficacy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-02
• Study Completion: 2018-09-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 87

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.

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)]