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NCT Number: NCT05676918

Maternal Well-being in the Postnatal Stage

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.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Disorder Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Covadonga Chaves Vélez

Madrid, Pozuelo de Alarcón, 28223, Spain

Location status: Recruiting

Location contact

Almudena Duque

CONTACT

[email protected]

Almudena Duque Sánchez

PRINCIPAL_INVESTIGATOR

Covadonga Chaves Vélez

CONTACT

[email protected]

+36 635321643

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Positive Psychology intervention

Behavioral

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

Cognitive Behavior Therapy

Behavioral

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

Primary outcomes

  1. Postpartum depression change

    Time frame: Immediately before and after the intervention

    Edinburgh Postpartum depression scale (EPDS). Scores range from 0 to 30, where higher scores mean a worse outcome.

Secondary outcomes

  1. Positive and Negative Affect change

    Time frame: Immediately before and after the intervention

    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.

  2. Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.

    Time frame: Immediately before and after the intervention

    Satisfaction With Life Scale

  3. Beliefs about pregnancy change

    Time frame: Immediately before and after the intervention

    The Pregnancy Related Beliefs Questionnaire (PRBQ-8). Scores range from 8 to 56. Higher scores indicate greater levels of dysfunctional attitudes towards motherhood.

  4. Psychological well-being change

    Time frame: Immediately before and after the intervention

    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.

  5. Maternal filial bond in the postpartum change

    Time frame: Immediately before and after the intervention

    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.

  6. Maternal self-efficacy change

    Time frame: Immediately before and after the intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Covadonga Chaves

CONTACT

[email protected]

+34635321643

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Universidad Pontificia de Salamanca

Registry information

Official study title

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

Acronym: BIEMAT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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