PreParent: Internet-based Digital Tools to Screen for and Prevent Postpartum Depression in Parents-to-be

Mental Health Services in the Capital Region, Denmark

Status: Invitation-only

Conditions: Post-partum Depression

Treatments: Behavioral: Online prenatal affective cognitive training

Study type: Interventional

Funder types: Other

Identifiers

NCT07302165

p-2024-16735

Details and patient eligibility

About

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.

Enrollment: 520 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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520 participants in 2 patient groups

Online prenatal affective cognitive training

Experimental group

Description:

Participants in this arm receive a 4-5-week online intervention consisting 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 independently on the online platform.

Treatment:

Behavioral: Online prenatal affective cognitive training

Care as usual (CAU)

No Intervention group

Description:

Participants in this arm receive care-as-usual (CAU) provided within the Danish healthcare system. They do not receive access to the online intervention but complete the same assessments and follow-ups as the intervention group.