Clinical trial NCT05676918: Maternal Well-being in the Postnatal Stage
Official title: Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Postpartum Disorder
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Pontificia de Salamanca
First posted: 2023-01-09
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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).

Primary outcomes:
measure: Postpartum depression change
timeFrame: Immediately before and after the intervention
Secondary outcomes:
measure: Positive and Negative Affect change
timeFrame: Immediately before and after the intervention
measure: Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome.
timeFrame: Immediately before and after the intervention
measure: Beliefs about pregnancy change
timeFrame: Immediately before and after the intervention
measure: Psychological well-being change
timeFrame: Immediately before and after the intervention
measure: Maternal filial bond in the postpartum change
timeFrame: Immediately before and after the intervention
measure: Maternal self-efficacy change
timeFrame: Immediately before and after the intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Covadonga Chaves Vélez
state: Pozuelo de Alarcón
Study officials:
affiliation: Universidad Complutense de Madrid
name: Covadonga Chaves, PhD
role: PRINCIPAL_INVESTIGATOR
References: