Maternal Well-being in the Postnatal Stage (BIEMAT)

Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Postpartum Disorder
• Intervention / Treatment: Behavioral: Positive Psychology Intervention; Behavioral: Cognitive Behavior Therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Covadonga Chaves; Phone Number: +34635321643; Email: cchavesv@psi.ucm.es

Study Locations

• Spain
  • Pozuelo de Alarcón
    • Madrid, Pozuelo de Alarcón, Spain, 28223
      • Recruiting
      • Covadonga Chaves Vélez
      • Contact: Covadonga Chaves Vélez; Phone Number: +36 635321643; Email: cchavesv@psi.ucm.es
      • Principal Investigator: Almudena Duque Sánchez
      • Contact: Almudena Duque; Email: aduquesa@upsa.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cognitive Behavior Therapy; Ten weekly sessions. Session duration: 90 minutes.	Behavioral: Cognitive Behavior Therapy; CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Experimental: Positive Psychology Intervention; Ten weekly sessions. Session duration: 90 minutes.	Behavioral: Positive Psychology Intervention; PPI includes 2 modules: hedonic well-being and eudaimonic well-being.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive and Negative Affect change	Positive and Negative Affect Scale (PANAS). Positive emotions scores range from 10 to 50, where higher scores mean a better outcome. Negative emotions scores range from 10 to 50, where higher scores mean a worse outcome.	Immediately before and after the intervention
Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.	Satisfaction With Life Scale	Immediately before and after the intervention
Beliefs about pregnancy change	The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.	Immediately before and after the intervention
Psychological well-being change	Psychological well-being scale by Ryff (PWBS). PWBS-29 is composed for 29 items with a minumum score of 29 and a maximum score of 174. Self-acceptance scores range from 4 to 24; Positive Relationships with others scores range from 5 to 30; Autonomy scores range from 6 to 36; Environmental mastery scores range from 5 to 30; Purpose in life scores range from 5 to 30 and Personal Growth scores range from 4 to 24. Higher score in each subscale means a better outcome.	Immediately before and after the intervention
Maternal filial bond in the postpartum change	The Postpartum Bonding Questionnaire (PBQ). Scores Range from 0 to 120. General factor scores range from 0 to 60 (Cut-off score 11= normal, 12 = high). Rejection of the infant scores range from 0 to 35. (cut-off 16 = normal, 17 = high). Infant-focused anxiety scores range from 0 to 10 (cut- off 9 = normal, 10 = high). Incipient abuse scores range from 0 to 10 ( cut-off 2 = normal, 3 = high). A high score in each factor indicates pathology.	Immediately before and after the intervention
Maternal self-efficacy change	Maternal Self-efficacy Questionnaire (MSQ). Scores range from 10 to 40, where equal or greater scores than 31 means a high perception of maternal self-efficacy.	Immediately before and after the intervention

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Universidad Pontificia de Salamanca
• Investigators: Principal Investigator: Covadonga Chaves, PhD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Depressive Disorder; Depression, Postpartum; Puerperal Disorders
• Other Study ID Numbers: UCM-UPS-WELLBEING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Since the end of the study (June 2024) and for 10 years
• IPD Sharing Access Criteria: The individual participant data can be provided on demand to guarantee the transparency of the study.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No