Maternal Well-being in the Postnatal Stage
BIEMAT
1 other identifier
interventional
98
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 9, 2023
CompletedStudy Start
First participant enrolled
January 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMay 21, 2025
May 1, 2025
2.4 years
November 10, 2022
May 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Postpartum depression change
Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.
Immediately before and after the intervention
Secondary Outcomes (6)
Positive and Negative Affect change
Immediately before and after the intervention
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
Immediately before and after the intervention
Beliefs about pregnancy change
Immediately before and after the intervention
Psychological well-being change
Immediately before and after the intervention
Maternal filial bond in the postpartum change
Immediately before and after the intervention
- +1 more secondary outcomes
Study Arms (2)
Positive Psychology Intervention
EXPERIMENTALTen weekly sessions. Session duration: 90 minutes.
Cognitive Behavior Therapy
ACTIVE COMPARATORTen weekly sessions. Session duration: 90 minutes.
Interventions
PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Eligibility Criteria
You may qualify if:
- Women who have been mothers in the last year
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Covadonga Chaves Vélez
Madrid, Pozuelo de Alarcón, 28223, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Covadonga Chaves, PhD
Universidad Complutense de Madrid
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
January 9, 2023
Study Start
January 16, 2023
Primary Completion
June 1, 2025
Study Completion
March 1, 2026
Last Updated
May 21, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Since the end of the study (June 2024) and for 10 years
- Access Criteria
- The individual participant data can be provided on demand to guarantee the transparency of the study.
Information on the evaluation and intervention protocol can be requested from the researchers. Likewise, the individual participant data can be provided on demand to guarantee the transparency of the study.