A multi-nutrient intervention for pregnant women experiencing symptoms of depression and anxiety.

Not Applicable

Completed

• Conditions: Depression; Anxiety; Mental Health - Depression; Reproductive Health and Childbirth - Normal pregnancy; Mental Health - Anxiety

• Registration Number: ACTRN12617000354381
• Lead Sponsor: Professor Julia Rucklidge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-08
• Study Completion: 2021-01-10
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 88

Inclusion Criteria

1) women aged 16 years and over; 2) 12-24 weeks gestation; 3) low risk singleton pregnancy; 4) free from psychiatric medication for four weeks; 5) score of 13 or more on the Edinburgh Postnatal Depression Scale (EPDS); 6) deemed reliable and compliant with the protocol.

Reference group inclusion criteria:
1) pregnant women aged 16 years and over; 2) low risk singleton pregnancy

Exclusion Criteria

1) regular vomiting; 2) high risk pregnancy; 3) significant pregnancy complications; 4) known foetal abnormalities; 5) serious current or historical medical condition; 6) known allergy to the ingredients of the intervention; 7) known metabolic condition such as Wilson’s disease, hemochromatosis.; 8) untreated or unstable thyroid disease; 9) known neurological disorder; 10) desire to continue taking prenatal supplements that either exceed the upper limit or are not required for medical purposes (decisions discussed and made on a case-by-case basis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Edinburgh Postnatal Depression Scale (EPDS; Cox et al, 1987) assesses the presence of depression and anxiety.[ Screening, baseline, every two weeks until birth and at 1 month, 6 months postpartum.];The Clinical Global Impressions Improvement Scale (Guy, 1976) produces a score based on how much the clinician (CGI-I) thinks the participant has improved since baseline ranging from 1 (very much improved) to 7 (very much worse).[ For the CGI-I every four weeks until birth and at 1 month, 6 months postpartum. ]