Maternal Well-being in the Postnatal Stage
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Positive Psychology Intervention, Cognitive Behavior Therapy.
- Кому может быть актуально
- Состояния в реестре: Postpartum Depression, Postpartum Disorder. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Maternal Well-being in the Postnatal Stage: Evaluation of Cognitive Biases and Validation of a Psychological Intervention
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Positive Psychology Intervention
PPI includes 2 modules: hedonic well-being and eudaimonic well-being. - Поведенческое Cognitive Behavior Therapy
CBT includes 3 modules: behavioral activation, cognitive restructuring, and interpersonal skills.
Первичные конечные точки
- Postpartum depression change [Срок оценки: Immediately before and after the intervention]
Вторичные конечные точки (6)
- Positive and Negative Affect change [Срок оценки: Immediately before and after the intervention]
- Satisfaction with life change (SWLS). Scores range from 5 to 35, where higher scores mean a better outcome. [Срок оценки: Immediately before and after the intervention]
- Beliefs about pregnancy change [Срок оценки: Immediately before and after the intervention]
- Psychological well-being change [Срок оценки: Immediately before and after the intervention]
- Maternal filial bond in the postpartum change [Срок оценки: Immediately before and after the intervention]
- Maternal self-efficacy change [Срок оценки: Immediately before and after the intervention]
Критерии участия
Критерии включения
- Women who have been mothers in the last year
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- Covadonga Chaves Vélez — Madrid
Публикации
- 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
Идентификаторы
NCT: NCT05676918 · UCM-UPS-WELLBEING