The (cost) effectiveness of an online intervention (MamaKits) for pregnant women with affective symptoms: a randomised controlled trial

Completed

• Conditions: angststoornissen en -afwijkingen NEG; Depression postpartum; postnatal depression; 10010273; 10027946

• Registration Number: NL-OMON39770
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 286

Inclusion Criteria

participants are included if:
1 they are pregnant in any stage of their pregnancy until 10 weeks before the expected date of delivery
2 they are 18 years or older and
3 they return an informed consent and
4 they have symptoms of depression and/or anxiety as defined by scoring above the cut-off of 15 ( *16) on the in the Center for Epidemiological Studies Depression scale (CES-D) and/or above the cut-off of 7 ( * 8) on the Hospital Anxiety and Depressionscale (HADS) and
5 they have access to a computer and
6 they have sufficient knowledge of the Dutch language

Exclusion Criteria

Exclusion criteria are:
1.age under 18
2.expected delivery date within 10 weeks. These women will be offered the intervention 6 weeks after giving birth at the same time as the controlgroup.
3.Symptoms are to mild as defined by a CES-D <16 and/or a HADS-A < 8
4. Severe suicidality as measured with one question of the Screening Questionnaire. Here the cut-off score is 3

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Decrease in depressive and anxiety symptoms shortly after the intervention and<br /><br>6 weeks postpartum, as measured with the CES-D and the HADS-A</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Improved perinatal outcome, as decreased pre-term birth and growth restriction)<br /><br>Less costs in medical consumption and in the social field</p><br>