Maternal Well-being in the Postnatal Stage

NCT ID: NCT05676918

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-16

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Participants will be randomly assigned to the CBT group or the PPI group. Both groups will be treated identically except for the type of intervention. Group assignment will be blind to both patients and investigators.

Both interventions have 10 weekly sessions. Sessions will be in groups and online.

CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. CBT approach; (2) Stress and Anxiety. Relaxation; (3 and 4) Increase pleasurable activities. Balance in life. To manage time; (5) Management of negative thoughts. Health concerns; (5 and 6) Increase positive thoughts; (7) social skills; (8) Communication skills and parner support; (9) Plan for the future. New routines and strategies; (10) Relapse prevention. CBT has been shown to be effective in reducing depressive symptoms and modifying attentional biases (Pearson et al., 2013).

On the other hand, a new protocol of positive interventions adapted for women after maternity (PPI) will be designed and applied. This multicomponent protocol includes interventions that have already been empirically validated in treating depression. PPI includes 2 modules: hedonic well-being and eudaimonic well-being. Main contents (10 sessions): (1) Symptoms of Depression. Myths about motherhood. PPI approach; (2) Mindfulness and positive emotions; (3) Gratitude and savoring; (4) Emotion regulation (5) Positive relationships and social support; (6) Compassion; (7) Personal strengths; (8) Goals and values; (9) Resilience; (10) Relapse prevention.

Conditions

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Postpartum Depression Postpartum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Positive Psychology Intervention

Ten weekly sessions. Session duration: 90 minutes.

Group Type EXPERIMENTAL

Positive Psychology Intervention

Intervention Type BEHAVIORAL

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

Cognitive Behavior Therapy

Ten weekly sessions. Session duration: 90 minutes.

Group Type ACTIVE_COMPARATOR

Cognitive Behavior Therapy

Intervention Type BEHAVIORAL

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

Interventions

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Positive Psychology Intervention

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

Intervention Type BEHAVIORAL

Cognitive Behavior Therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Pontificia de Salamanca

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Covadonga Chaves, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Covadonga Chaves Vélez

Madrid, Pozuelo de Alarcón, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Covadonga Chaves

Role: CONTACT

+34635321643

Facility Contacts

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Covadonga Chaves Vélez

Role: primary

+36 635321643

Almudena Duque

Role: backup

Other Identifiers

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UCM-UPS-WELLBEING

Identifier Type: -

Identifier Source: org_study_id

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