Promoting Maternal Mental Health: Applicability and Effectiveness of an eHealth Intervention for Portuguese Postpartum Women
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Changes from baseline in the presence of positive mental health
研究概览
简要总结
Be a mom (a web-based cognitive-behavioral intervention) is being tested in another trial as a preventive intervention in the postpartum period (NCT03024645). However, given its content and the focus on developing and strengthening psychological resources, it is important to understand if Be a Mom is also effective in promoting maternal mental health of postpartum women who are not at risk of developing postpartum depression. Thus, the main goal of this research is to apply and evaluate Be a Mom for the promotion of mental health, in terms of its efficacy, acceptability and feasibility (user's adherence, dropout), user's satisfaction and cost-effectiveness.
The RCT will be a two-arm trial. Women with a child aged up to 3 months old will be enrolled in the study. A minimum number of 1000 women will be enrolled in the study. After agreeing to participate in the study, the women will be screened for the absence of risk factors for PPD (PDPI-R < 5.5). In case of a negative screen, women will be randomly assigned to one of two conditions: the intervention (Be a Mom program) or the control condition. The sample will be recruited online.
Participation in this study will last 15 months. The Be a Mom program will last 5 weeks. Participants in both conditions will be invited via email to complete baseline, post-intervention and follow-up assessments (4-months and 12-months after post-intervention). Assessments will include self-report questionnaires to assess several indicators (e.g., positive mental health, quality of life, marital satisfaction, depressive and anxiety symptoms, maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., self-compassion, emotional regulation), user's acceptability and satisfaction and cost-effectiveness.
详细描述
In the present study, a web-based intervention to promote women's mental health in the transition to motherhood (the Be a Mom program) will be tested. The design and content development of the Be a Mom program was conducted through a formative evaluation process.
The transition to motherhood is a widely studied period that is characterized as demanding for mothers, and that entails an adjustment to lifestyle changes and new responsibilities. There is extensive research suggesting that this period is a time of increased risk for psychological problems, such as postpartum depression. In turn, this can lead to numerous negative consequences to the mother and the child's development.
Even women who are not at an immediate risk of developing postpartum depression face numerous challenges and concerns that may place them in a vulnerable position (e.g., health needs, infant care, conflict with partner, changes in marital/social relationships, transitioning back to work). Despite this, research on the transition to motherhood has largely focused on women at risk or presenting mental illness, overlooking all women in the postpartum period and their positive mental health.
Evidence shows that positive mental health over time functions as a resilience resource and protects against both physical and mental illness. There is also evidence suggesting that the lack of positive mental health may also make individuals more vulnerable to future adversities. This implies that the promotion of positive mental health should be an additional goal in public and mental health care that complements the treatment of psychopathology.
Be a Mom is self-guided web-based intervention grounded on CBT principles that also includes recent developments in acceptance and commitment based-therapies, specifically for the perinatal context. This program focuses on the development and enhancement of psychological resources such as self-compassion and psychological flexibility and an increase of mental health literacy. Be a Mom has a modular set-up that is updated weekly, with each module addressing one or two specific thematic contents (Changes and reorganizations during the transition to parenthood; Emotional diversity; Cognitions; Relationship with others [social support and communication]; Couple relationship; Signs and symptoms of depression and help-seeking). In each module, participants will be provided with both psychoeducational content and therapeutic strategies. Informational material will be given in text format, combined with audio, video and/or animations. The Be a Mom program will also include interactive tools and feedback tools to support learning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
Single-blind - the investigator is unaware of the intervention assignment
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having 18 years or more;
- •Being female;
- •Having had a live healthy birth in the last 3 months, with both woman and the child discharged from hospital;
- •Internet access at home.
- •Absence of risk factors for Postpartum Depression (PDPI-R < 5.5).
排除标准
- •Current diagnosis of serious mental health condition (e.g., substance abuse, bipolar disorder);
- •Currently receiving treatment for depressive symptoms, including antidepressant medication or psychotherapy;
- •Language difficulties that impede comprehension/reading-writing;
结局指标
主要结局
Changes from baseline in the presence of positive mental health
时间窗: From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention
Measured with Mental Health Continuum-SF (MHC-SF; Keyes et al., 2008). The MHC-SF can be scored continuously (scores range from 0 to 70, and higher scores indicate better positive mental health) or categorically considering mental health status (flourishing, moderate mental health, languishing)
次要结局
- Changes from baseline in anxiety symptoms(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Changes from baseline in self-empowerment(From baseline to postintervention (8 weeks after randomization); 4 months postintervention)
- Changes from baseline in emotional regulation(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Changes from baseline in depressive symptoms(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Changes from baseline in self-compassion(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Medical Costs(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Changes from baseline in marital satisfaction: Marital Satisfaction Subscale of the Investment Model Scale(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Changes from baseline in maternal self-efficacy(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Acceptability of the program for postpartum women: Measured through specific questions(Measured at post-intervention (8 weeks after randomization))
- Changes from baseline in psychological flexibility(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
- Parental psychological flexibility(Measured at follow-up (4 and 8 months postintervention))
- Feasibility of the program for postpartum women (Measured through the website utilization)(Measured at post-intervention (8 weeks after randomization))
- Health state and EQ-VAS(From baseline to postintervention (8 weeks after randomization); 4 and 8 months postintervention)
研究者
Ana Fonseca
Principal Investigator
University of Coimbra