bBeAMom Trial: A Randomized Controlled Trial to Test the Effectiveness of a Cognitive-Behavioral Blended Intervention for Postpartum Depression in Portuguese Women
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Changes from baseline in depressive symptoms
研究概览
简要总结
Be a mom program (a web-based cognitive-behavioral intervention) is being tested in another clinical trial as a preventive intervention for postpartum depression (NCT03024645). However, given its effectiveness in reducing depressive symptoms among women presenting early-onset postpartum depressive symptoms, Be a Mom can also have potential as a postpartum depression complement treatment tool. The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression (Be a Mom Coping with Depression) by integrating face-to-face sessions with the web-based program Be a Mom.
The RCT will be a two-arm trial. Women who have had a child during the prior 12 months will be enrolled in the study. A minimum number of 110 women will be enrolled in the study. After agreeing to participate in the study, women will be screened and evaluated for the presence of clinically significant depressive symptoms (according to DSM-5) by a researcher (licensed psychologist). Participants who meet the eligibility criteria will be randomly assigned to one of the conditions: the blended intervention (Be a Mom Coping with Depression) or the control condition (online intervention - Be a Mom). The sample will be recruited online.
Participation in this study will last 6 months. The blended intervention will last about 3 months. Participants in both conditions will be invited by the researchers via email to complete baseline, post-intervention and follow-up (3-months post-intervention) assessments. Assessments will include self-report questionnaires to assess several indicators (e.g., depressive and anxiety symptoms, quality of life, marital satisfaction, mother-child bonding, and maternal self-efficacy), mechanisms that may be involved in the treatment response (e.g., psychological flexibility, emotional regulation, and self-compassion) and user's acceptability and satisfaction.
详细描述
In the present study, a blended intervention to treat postpartum depression (Be a Mom Coping with Depression) will be tested.
The main goal of this research is to apply and evaluate the acceptability and effectiveness of a blended cognitive-behavioral intervention for the treatment of postpartum depression by integrating face-to-face sessions with the web-based program Be a Mom. The efficacy of the intervention will be assessed considering two indicators: a) decrease or absence of clinically significant depressive symptoms at post-intervention and follow-up; and b) post-intervention and follow-up improvements in mother's psychosocial adjustment indicators (e.g., anxiety symptoms, marital satisfaction, maternal self-efficacy). The present study will also aim to investigate the mechanisms explaining the treatment response (e.g., psychological flexibility, self-compassion) and characteristics moderating the treatment response (e.g., motivation for therapy, therapeutic relationship).
The research design of the trial followed the methodological recommendations for the development and evaluation of blended interventions. A feasibility study was conducted prior to the randomized controlled trial (RCT), in order to evaluate preliminary version of the blended intervention. The feasibility study was conducted with women with a clinical diagnosis of postpartum depression according to the Structured Clinical Interview for DSM-5 (SCID-5) disorders criteria. Pre- and post-intervention assessments, using self-report questionnaires, and individual interviews were used to gather information concerning acceptability (relevance of contents and structure), feasibility, usability and preliminary clinical effectiveness (non-controlled). Appropriate adjustments to the blended protocol were carried out considering the results.
The RCT will be a two-arm trial. The intervention condition (blended intervention - Be a Mom Coping with Depression) will be compared with a control condition (online intervention - Be a Mom). The sample will include adult women who delivered an healthy baby in the postpartum period (up to 12 months postpartum). Women will be enrolled through online recruitment. A minimum number of 45 women per condition will be required (N=90). Accounting for the 20% of expected attrition rate over time, an anticipated sample of 110 women will be enrolled in the study.
Women who demonstrate interest in the study will be informed of the study goals, the structure and arms of the research and the researchers' and participants' roles. Women who agree to participate in the study will sign an informed consent form. All ethical requirements for research with humans are guaranteed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having 18 years or more;
- •Being female;
- •Being Portuguese;
- •Baby's age up to 12 months;
- •Presence of at least 4 symptoms of a major depressive episode according to DSM-5, being one depressed mood or lost of pleasure or interest;
- •Having had a live healthy birth, with both woman and the child discharged from hospital;
- •Internet and computer access;
- •Being able to write and read Portuguese.
排除标准
- •Presence of psychiatric comorbidity requiring alternative treatment primary to depression treatment (e.g., substance abuse, bipolar disorder);
- •Presence of serious suicidal ideation;
- •Presence of serious medical condition (either the participant or the baby);
- •Currently receiving psychological or psychiatric treatment for depressive symptoms (antidepressant medication is allowed if stabilized for the last 3 months);
- •Language difficulties that impede comprehension/reading-writing.
- •All participants will be informed that they will be randomized to one of the study groups and that will only be included if they give informed consent to participate in the study.
结局指标
主要结局
Changes from baseline in depressive symptoms
时间窗: Baseline, 3 and 6 months
Measured with Edinburgh Postnatal Depression Scale (EPDS). The total score can range between 0 and 30, and higher scores are indicative of more severe depressive symptoms.
次要结局
- Usability of the intervention for postpartum women(3 months)
- Feasibility of the program for postpartum women as measured by website average visit length(3 months)
- Acceptability of the intervention for postpartum women(3 months)
- Changes from baseline in anxiety symptoms(Baseline, 3 and 6 months)
- Changes from baseline in quality of life(Baseline, 3 and 6 months)
- Changes from baseline in emotional regulation(Baseline, 3 and 6 months)
- Changes from baseline in maternal self-efficacy(Baseline, 3 and 6 months)
- Changes from baseline in mother-child bonding(Baseline, 3 and 6 months)
- Changes from baseline in self-compassion(Baseline, 3 and 6 months)
- Changes from baseline in psychological flexibility(Baseline, 3 and 6 months)
- Changes from baseline in expectancy for therapy(Baseline and 3 months)
- Therapeutic relationship(3 months)
- Changes from baseline in the frequency of negative thoughts(Baseline, 3 and 6 months)
- Changes from baseline in marital satisfaction(Baseline, 3 and 6 months)
- Feasibility of the online program for postpartum women as measured by number of website logins(3 months)
- Feasibility of the intervention for postpartum women as measured by dropout rate(3 months)
研究者
Ana Fonseca
Principal Investigator
University of Coimbra