Online 1-Day CBT-Based Workshops for Preventing Postpartum Depression: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 412
- 试验地点
- 1
- 主要终点
- EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.
研究概览
简要总结
To conduct a randomized controlled trial (N=408) examining the impact of an online cognitive behavioural therapy (CBT)-based workshop on rates of postpartum depression (i.e., EPDS scores at 2-months postpartum) when added to treatment as usual (TAU) compared to TAU alone.
详细描述
Postpartum depression affects up to 1 in 5 mothers, however just 15% receive evidence-based treatment. It is associated with negative consequences for women and their families with enormous costs to the healthcare system. Postpartum depression is an ideal candidate for prevention because it is common, the window of opportunity to intervene is clear (pregnancy), and its risk factors are well-established and easily identifiable. Furthermore, women are in frequent contact with the healthcare system during pregnancy and are more motivated to improve their health during this time than at any other time in their lives. Given the high rate of PPD and its adverse effects on mothers and their families, and the relative lack of efficient, effective psychotherapeutic interventions for preventing PPD, safe, novel, and efficient preventive interventions are needed. Since large 1-day workshops appear to successfully treat depression, given the widespread interest and investment of public health units across Canada in maternal and child health, Online 1-Day CBT-Based Workshops for Preventing PPD should be developed and tested for their ability to prevent PPD in Canadian women.
Based on longstanding clinical work with women at high risk for PPD, the development of a successful 1-Day CBT-Based Treatment Workshop for PPD and its delivery in-person and online, and an extensive review of the PPD prevention literature, the investigators developed the content for our prevention workshop as well as an accompanying script and intervention manual for participants in a previous pilot study. This pilot study also assessed feasibility by recruiting 32 women who took part in an online CBT-based workshop and provided feedback on its content, delivery and assessment procedures. The workshop, manual, and study protocol were subsequently refined and our experience recruiting participants in community settings into CBT treatment studies for PPD will be utilized in the current randomized controlled trial (N=408), which is aimed as assessing the effectiveness of these workshops at reducing the likelihood of developing PPD in women at risk.
Objectives of the proposed randomized controlled trial are as follows:
Primary: To determine if Online 1-Day CBT-Based Workshops delivered to pregnant persons with a past history of major depressive disorder (MDD) and added to TAU reduces EPDS scores at 2-months postpartum more than TAU alone and to determine if these workshops reduce the risk of developing PPD (EPDS score ≥13 at 2 months postpartum).
Secondary: To determine if 1-Day CBT-based workshops lead to differences in the common comorbidities of PPD (maternal anxiety, problems with the mother-infant relationship, infant temperament, maternal social support, and maternal perceived stress) between the experimental and control groups.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 单盲 (结局评估者)
盲法说明
Participants and the research coordinator cannot be blinded to group condition though the research assistants sending out 1, 2, and 3 month postpartum follow questionnaires and data analysts will not be aware of group status.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 18 years of age or older
- Currently residing in Ontario, Canada
- Currently in 3rd trimester of pregnancy (28-36 weeks gestation)
- EPDS score >6
- Past history of major depressive disorder (determined using the Mini International Neuropsychiatric Interview (MINI)
排除标准
- positive score on the MINI for a current major depressive episode
- positive score on the MINI subsections of bipolar, psychotic, or borderline personality disorder
研究组 & 干预措施
Treatment as Usual
Participants assigned to the control arm will continue to receive standard prenatal care from their healthcare providers.
Online 1-Day CBT-Based Workshop
Participants assigned to the treatment arm will attend a day long CBT-based workshop delivered online by two trained facilitators in addition to receiving usual care.
干预措施: Online 1-Day Cognitive Behavioural Therapy-Based Workshop (Behavioral)
结局指标
主要结局
EPDS score as a continuous outcome (Total EPDS) and an EPDS score of 13 or more at 2-months postpartum (T3) will serve as co-primary outcomes.
时间窗: Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4)
Edinburgh Postnatal Depression Scale (EPDS): the gold standard measure of PPD symptoms in clinical practice and research. The EPDS is a self-report 10-item scale scored out of 30 points that measures the severity of depressive symptoms in the past 7 days. Scores are between 0 and 30, with higher scores indicating the presence of more depressive symptoms. Scores of 13 and above indicate depressive illness, or a high risk of developing a depressive disorder. A reduction of four points in the EPDS is recognized as a clinically significant improvement.
次要结局
- Problems with the Mother-Infant Relationship (Postpartum Bonding Questionnaire (PBQ))(1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4))
- Maternal Perceived Stress (Perceived Stress Scale (PSS))(Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4))
- Maternal Anxiety (Generalized Anxiety Disorder 7-Item Scale (GAD-7))(Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4))
- Maternal Social Support (MSPSS)(Baseline (T1), 1-month postpartum (T2), 2-months postpartum (T3), and 3-months postpartum (T4))
- Infant Temperament (Infant Behaviour Questionnaire-Revised (IBQ-R))(3-months postpartum (T4))
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05753176
- 其他研究编号
- RCT1-day CBT to prevent PPD
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (9个月前)
- 研究完成日期
- (9个月前)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
