Technology-Enabled (Electronic) Measurement Based Care(MBC) for Perinatal Depression and Anxiety: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Feasibility of the trial protocol: Recruitment
研究概览
简要总结
Depression and anxiety that occur around the time of pregnancy can adversely impact a person's health and well-being, and their child's health and development. Fewer than 20% of affected people are adequately treated, often because of under-use of medications. Measurement based care (MBC) is a model of care where psychiatric symptoms are routinely tracked and reviewed together by a patient and their doctor to better manage symptoms. It has not been systematically evaluated for perinatal depression and anxiety. The overall objective of this study is to test the feasibility of MBC in this population to inform a future large randomized controlled trial for definitive evaluation. In order to avoid known barriers to MBC, electronic MBC (eMBC) will be used. With eMBC, patients can enter their symptoms into their electronic medical records before their appointment so that they can be evaluated by their doctor during the appointment. In this pilot study, the feasibility of recruitment for a future efficacy trial, including feasibility of recruitment, and retention, acceptability and adherence to a trial protocol will be evaluated.
详细描述
A parallel group randomized controlled trial (RCT) will be conducted. Eligible and consenting patients with depression and/or anxiety will be randomized in a 1:1 ratio to either the eMBC condition or a control condition. The study will be stratified by diagnosis (major depressive disorder vs generalized anxiety disorder).
80 patient participants will be recruited from the Reproductive Life Stages (RLS) Program at Women's College Hospital. The active treatment phase of the study is 12 weeks.
Outcomes will be measured online and by phone at 4-, 8-, and 12- weeks post-randomization. Following the completion of the study, some participants will be asked to participate in follow-up interviews. RLS psychiatrists whose patients participated in the study will participate in a focus group.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The RA randomizing the participant will be not be blinded to the treatment allocation because they have to inform the provider of the treatment allocation. This RA will not be collecting outcome measures. The RA collecting outcome measures will be blinded to the treatment allocation.
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
- •Currently pregnant or mother* of a live infant 0-12 months of age and living at the same residence
- •*Through natural birth, adoption, surrogacy, including cis women, non-binary and transgender people in all their diversity
- •EPDS >12 at enrollment
排除标准
- •Active suicidal ideation, substance abuse or dependence
- •Current or past mania or psychosis or current major depressive episode with psychosis
- •Incapable of consenting to participation
- •Unable to read or unable to speak English
结局指标
主要结局
Feasibility of the trial protocol: Recruitment
时间窗: 12 weeks post randomization
Measures of recruitment include rate of recruitment and reason for non-participation.
Feasibility of the trial protocol: Participant Acceptability
时间窗: 12 weeks post randomization
Surveys and interviews will be used to capture data relating to perceived usefulness and acceptability of technology and its perceived benefit. These will be combined to capture an overall acceptability measure.
Feasibility of the trial protocol: Provider Acceptability
时间窗: 12 weeks post randomization
Surveys and focus groups will be used to capture data relating to usability and tolerability of eMBC in clinical practice.
Feasibility of the trial protocol: Adherence
时间窗: 12 weeks post randomization
Chart review will be used to measure the number of visits, the proportion of visits with completed scales and which scales were completed, proportion of visits where review of symptom scales was documented in the patient record, the proportion of visits where providers recorded that they used the data from symptom scales to inform the treatment, and proportion of visits where medication was started, changed, dose adjusted or stopped. These will be combined to provide an overall measure of how closely the intervention protocol was followed.
次要结局
- Clinical outcomes - anxiety symptoms(4, 8, and 12 weeks post randomization)
- Clinical outcomes - functional capacity(each clinical appointment up to 12 weeks post randomization)
- Clinical outcomes - social functioning(each clinical appointment up to 12 weeks post randomization)
- Clinical outcomes - clinician-assessed depression symptoms(4, 8, and 12 weeks post randomization)
- Clinical outcomes - self-report depression symptoms(each clinical appointment up to 12 weeks post randomization)
- Clinical outcomes - antidepressant side effects(each clinical appointment up to 12 weeks post randomization)
研究者
Simone Vigod
Chief, Department of Psychiatry
Women's College Hospital