Patient Decision Aid (PDA) for Antidepressant Use In Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recruitment Rate
研究概览
简要总结
The purpose of this pilot study is to examine the feasibility of conducting a multi-site randomized controlled trial whose aim will be to evaluate the effectiveness of a Patient Decision Aid (PDA) for antidepressant use in pregnancy.
详细描述
Depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. Unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. Clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. Patient decision support tools can address such barriers. We have created a patient decision aid (PDA) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. The overall objective of this project is to inform the development of a larger, international RCT to assess the efficacy of our PDA for antidepressant use in pregnancy. To achieve this objective, we will assess the feasibility of our clinical trial protocol to evaluate the PDA and determine the preliminary effect size for a larger multi-site efficacy study. The primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the PDA. This includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). We hypothesize that our protocol will be feasible, that the PDA will have a high degree of acceptability, and that adherence to the protocol will be high.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Recruitment Rate
时间窗: Up to one year from when the study starts enrolling participants
Feasibility: Number of participants recruited into the study over Number of eligible patients
次要结局
- PDA Acceptability Questionnaire(4 Weeks post-randomization)
- Edinburgh Postnatal Depression Scale(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
- Spielburg State-Trait Anxiety Inventory(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
- Self-reported satisfaction with the PDA by the participants(4 Weeks post-randomization)
- Decisional Conflict Scale(4 Weeks post-randomization)
- Knowledge about antidepressant treatment in pregnancy(4 Weeks post-randomization)
- Provider Perspective Survey(After all other participant data has been collected)
- Treatment Decision(s)(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), only for participants who are seeing specialty psychiatric services)
- Time between recruitment to first log-in to the study website(4 weeks post-randomization)
- Provider's perspective on the utility of the PDA in clinical practice(After all participant data has been collected)
- Study Website Usage(4 Weeks post-randomization)
- Number of participants who follow-up with their physician during the intended timeline(4 weeks post-randomization, only for participants who are seeing specialty psychiatric services)
- The rate of follow-up data collection(12 weeks postpartum (for participants who enrolled while pregnant) OR 6 months post-randomization (for women who enrolled while planning a pregnancy), OR at 4 weeks post-randomization for women who are NOT seeing specialty perinatal psychiatry services)
研究者
Simone Vigod
Psychiatrist
Women's College Hospital