Post-partum Depression
Conditions
Keywords
Prevention intervention, Postpartum depression, Digital psychiatry, Online therapy, Risk factors, Pregnancy
Brief summary
The goal of this randomized controlled study is to evaluate whether an online intervention that combines psychoeducation and affective cognitive training can help prevent postpartum depression in pregnant women and co-parents who have been identified as having risk factors for postpartum depression through an online screening tool. A total of 520 expecting parents will be enrolled in the intervention trial. Researchers will compare the online intervention to care as usual (CAU) in the Danish healthcare system to determine whether the intervention has a better preventive effect. The study also involves a low-risk comparison group (n = 5250) who will not receive the intervention but will complete the same assessments for background comparisons. The main question is: \- Does the online intervention reduce the number of mothers who develop postpartum depression during the first six months after birth? Other questions the study addresses include: * How severe mothers' depressive symptoms are during the first six weeks postpartum, based on weekly online ratings? * How do parents report their own stress levels and their infant's development six months after birth? The study will also explore: * How many co-parents develop postpartum depression during the first six months postpartum. * Whether mothers experience additional benefit if their co-parent also completes the intervention. Participants will: * Complete a 4-5-week online intervention with 8-9 modules that include psychoeducation and cognitive-affective training. * Complete online questionnaires and outcome assessments from home. * Participate in a diagnostic interview by phone after birth.
Interventions
BEHAVIORALOnline prenatal affective cognitive training
Participants receive a 4-5 week online intervention concisting of 8-9 modules. The program includes psychoeducation on perinatal emotional health and cognitive-affective training exercises designed to reduce risk factors for postpartum depression. All content is completed idenpendently on the online platform.
Sponsors
University of Bergen
University of Copenhagen
University of Southern Denmark
Lund University
Mental Health Services in the Capital Region, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women in their second or third trimester, or co-parents. * Age ≥ 18 years. * Ability to speak and read Danish. * A cut-off score \> 96 on a test of negative cognitive bias (scale 0-100), and/or a score \> 23 on the Antenatal Risk Questionnaire (ANRQ). * Co-parents are categorized as at risk if their partner is identified as having risk factors.
Exclusion criteria
* Current or past mental disorders within ICD-10 categories F00-F29 and F60-F69. * Current substance use. * EPDS score ≥ 11 for women or ≥ 10 for men, indicating clinically relevant depressive symptoms at baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Postpartum Depression in Mothers Assessed at 6 Months Postpartum | 6 months postpartum | Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether participants meet criteria for postpartum depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average Severity of Maternal Depressive Symptoms During the First 6 Weeks Postpartum | Weekly assessments from birth to 6 weeks postpartum | Measured using weekly online ratings on the Edinburgh Postnatal Depression Scale (EPDS). Scores are averaged across the 6-week postpartum period to estimate overall symptom severity. |
| Self-Reported Parental Stress at 6 Months Postpartum | 6 months postpartum | Measured using an online questionnaire assessing parental stress levels at 6 months after birth. |
| Parent-Reported Infant Development at 6 Months Postpartum | 6 months postpartum | Measured using an online parent-report questionnaire assessing infant developmental functioning at 6 months of age. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Postpartum Depression in Co-Parents Assessed at 6 Months Postpartum | 6 months postpartum | Measured using the Present State Examination (PSE) diagnostic interview at 6 months postpartum to determine whether co-parents meet criteria for postpartum depression. |
| Occurrence of Postpartum Depression in Mothers Whose Co-Parent Also Receives the Intervention | 6 months postpartum | Exploratory comparison evaluating whether mothers whose co-parent also completes the online intervention show lower occurrence of postpartum depression at 6 months postpartum, compared with mothers whose co-parent does not receive the intervention. |
Countries
Denmark
Outcome results
None listed