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Recruiting NCT05676918

Maternal Well-being in the Postnatal Stage

No phase Interventional Postpartum Depression Postpartum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Positive Psychology Intervention, Cognitive Behavior Therapy.
Who it may be relevant to
Registry conditions: Postpartum Depression, Postpartum Disorder. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • Behavioral Positive Psychology Intervention
    PPI includes 2 modules: hedonic well-being and eudaimonic well-being.
  • Behavioral Cognitive Behavior Therapy
    CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.

Primary outcome measures

  • Postpartum depression change [Time frame: Immediately before and after the intervention]
Secondary outcome measures (6)
  • Positive and Negative Affect change [Time frame: Immediately before and after the intervention]
  • 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]
  • Beliefs about pregnancy change [Time frame: Immediately before and after the intervention]
  • Psychological well-being change [Time frame: Immediately before and after the intervention]
  • Maternal filial bond in the postpartum change [Time frame: Immediately before and after the intervention]
  • Maternal self-efficacy change [Time frame: Immediately before and after the intervention]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Covadonga Chaves Vélez — Madrid

Publications

  • Nombela E, Duque A, Salgado G, Chaves C. A Comparative Analysis of the Acceptability of the MATER Positive Psychology Intervention Versus Cognitive Behavioural Therapy in Women With Postpartum Depression. Clin Psychol Psychother. 2026 May-Jun;33(3):e70281. doi: 10.1002/cpp.70281. PMID 42089829

Identifiers

NCT: NCT05676918 · UCM-UPS-WELLBEING

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗