Maternal Well-being in the Postnatal Stage

NCT05676918 · tracked via the Priya Life Science Spain tracker

Sponsor

Universidad Complutense de Madrid

Phase

Not applicable

Started

2023-01-16

Last updated

2025-05-21

Condition(s) studied

Postpartum DepressionPostpartum Disorder

Investigational drug(s) / intervention(s)

Positive Psychology InterventionCognitive Behavior Therapy

Positive Psychology Intervention: PPI includes 2 modules: hedonic well-being and eudaimonic well-being.

Cognitive Behavior Therapy: CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.

Study summary

The objective of this study is to design and validate an online intervention aimed at promoting well-being in women with postpartum depression. For this, the design of a multicomponent protocol consisting of empirically validated positive interventions and comparing these with a group Cognitive Behavioral Therapy (CBT) is proposed, following the National Institute for Health and Care Excellence (NICE) recommendations for the treatment of depression. Participants will be screened for inclusion in the program if they meet clinical criteria. After that, they will be randomly assigned to a CBT group or a positive psychology intervention (PPI) group.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Women who have been mothers in the last year Exclusion Criteria: * Women who have been mothers in the last month, * Women who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for substance abuse and/or dependence within 30 days prior to study participation, * Women who have a serious mental disorder that makes it difficult to follow the protocol (e.g. serious neurocognitive problems or brain damage; schizophrenia and other psychotic disorders).

Primary outcome measure(s)

Postpartum depression change — Immediately before and after the intervention
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.

Trial sites (1)

Facility	City	Region	Status
Covadonga Chaves Vélez	Madrid	Pozuelo de Alarcón	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05676918 on ClinicalTrials.gov ↗ ← All trials in Spain