Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT05676918
Status:
RECRUITING
Last Update Posted:
2025-05-21
First Post:
2022-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal Well-being in the Postnatal Stage
Sponsor:
Universidad Complutense de Madrid
Organization:
Study Overview
Official Title:
Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIEMAT
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: