Maternal Well-being in the Postnatal Stage

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05676918
Study type	Interventional
Source	Universidad Complutense de Madrid
Contact	Covadonga Chaves
Phone	+34635321643
Email	cchavesv@psi.ucm.es
Status	Recruiting
Phase	N/A
Start date	January 16, 2023
Completion date	June 2024

View Details

See also
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Completed	`NCT04146025` - Nurtured in Nature	N/A
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Completed	`NCT05059600` - A Study To Assess The Safe-Use Conditions For Administration of ZULRESSO® in a Home Setting	Phase 4
Completed	`NCT06136520` - The Effect of Baby Massage Training Given to Pregnant Women on Maternal Attachment and Postpartum Depression	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Maternal Well-being in the Postnatal Stage — BIEMAT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms