Perinatal depressive symptoms and subjective well-being Mental and Behavioural Disorders
Conditions
Interventions
Current interventions as of 14/11/2025:
The overall aim of the current project is to test the effectiveness, cost-effectiveness, and implementation of Mamma Mia with guidance compared to unguided Mam
Sponsors
The Research Council of Norway
Eligibility
Sex/Gender
Female
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged 18 years and over 2. Up until 26 gestational weeks 3. Provide a valid email address 4. Read and understand Norwegian at a high-school level
Exclusion criteria
Exclusion criteria: 1. Pregnant women who are beyond gestational week 26 2. Aged less than 18 years 3. Do not provide a valid email address Added 14/11/2025: 4. Acute and ongoing personal crisis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 28/10/2025: 1. Depression measured using the Edinburgh Postnatal Depression Scale (EPDS) at baseline (approx. gestational week 25), gestational week 37, 1.5, 3, 6, and 12 months postpartum 2. Subjective well-being measured using the Satisfaction with Life Scale and the Positive and Negative Affect Scale at baseline (approx. gestational week 25), gestational week 37, and 1.5, 3, 6, and 12 months postpartum 3. Anxiety measured by the (a) anxiety sub-scale of the EPDS (i.e., EPDS-3A) and (b) the Acute anxiety and adjustment subscale of the Perinatal Anxiety Screening Scale at baseline (approx. gestational week 25), gestational week 37, and 1.5, 3, 6, and 12 months postpartum Implementation primary outcomes: 1. Acceptability, appropriateness and feasibility respectively measured using the Acceptability of Intervention Measure, the Intervention Appropriateness Measure and the Feasibility of Intervention Measure at approx. 3 and 15 months after training and initial instructional meetings 2. Systems and capacity changes measured using the Systems and Capacity Changes –Section D at approx. 3 and 15 months after training and initial instructional meetings 3. Working alliance measured using Working Alliance Inventory–Short Revised at approx. 3 and 15 months after training and initial instructional meetings 4. Implementation outcomes measured using the Implementation Components Questionnaire–Implementation Outcomes at approx. 3 and 15 months after training and initial instructional meetings _____ Previous primary outcome measures: 1. Depression measured using the Edinburgh Postnatal Depression Scale at baseline (approx. gestational week 25) at gestational week 37 and 1.5, 3, 6, and 12 months postpartum 2. Subjective well-being measured using the Satisfaction with Life Scale and the Positive and Negative Affect Scale at baseline (approx. gestational week 25), gestational week 37, and 1.5, 3, 6, and 12 months postpartum 3. Anxiety mea | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life score measured by 5-Level EuroQoL-5D at baseline (approx. gestational week 25), gestational week 37, and 1.5, 3, 6, and 12 months postpartum 2. Relationship satisfaction measured using Relationship Satisfaction (RS) at baseline, 6 weeks postpartum, and 6 and 12 months postpartum 3. Self-efficacy measured using Coping Self-Efficacy (SE) at baseline 4. Attachment measured using Prenatal Attachment Inventory at baseline and gestational week 37 5. Stress measured using Perceived Stress Scale at baseline, 1.5, 6, and 12 months postpartum 6. Breastfeeding self-efficacy measured using the Breastfeeding Self-Efficacy Scale at 1.5, 3, 6, and 12 months postpartum 7. Social support measured using Berlin Social Support Scales at baseline, gestational week 37, and 1.5, 3, 6, and 12 months postpartum 8. Emotion regulation measured using the Emotion Regulation Questionnaire at baseline, 1.5, 6, and 12 months postpartum 9. Sleep measured using the Brief Infant Sleep Questionnaire at 1.5, 3, 6, and 12 months postpartum 10. Infant socio-emotional development measured using Ages & Stages Questionnaire: Socio-Emotional at 1.5, 3, 6, and 12 months postpartum Implementation secondary outcome measures: 1. Adherence to the guidelines for the implementation and the clinical work in the blended intervention group, measured using an Adherence checklist that will be completed by health personnel after all consultations for all the postpartum women who receive guidance in using Mamma Mia 2. Log data recorded continuously throughout the Mamma Mia program 3. The implementation process will be explored at focus groups completed with health personnel at one timepoint during the project period 4. The plan for implementation will be completed by health personnel in the blended intervention following training and before recruitment of pregnant women 5. SWOT interview (strength, weaknesses, opportunities, threats) completed with perinatal women (approx. after when th | — |
Countries
Norway
Outcome results
None listed