Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in postpartum depression symptoms
研究概览
简要总结
This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are:
- How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth?
- Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers?
- Is a CM-PST intervention practical for new mothers?
The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage.
Participants will:
- Complete 4 remote intervention sessions over 6 weeks
- Conduct at-home urine drug tests 2x per week during the 6-week intervention
- Answer online surveys about their mental health and alcohol use
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
- 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
- •Biologically female
- •Age ≥18 years
- •Within 12 months postpartum
- •Able to provide informed consent
排除标准
- •Serious medical or psychiatric conditions requiring hospitalization
- •Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychiatric disorder
- •Current use of psychoactive drugs, medication to treat problematic alcohol use, or depression
- •Participation in past 6 months in problematic alcohol use or substance use treatment
- •Unable to provide consent
研究组 & 干预措施
Contingency Management & Problem Solving Therapy (CM-PST) Intervention Group
Receives 4 remote sessions of CM-PST therapy over 6 weeks while conducting at home urine drug tests 2x weekly.
干预措施: Contingency Management & Problem Solving Therapy (Behavioral)
Usual Care Control Group
干预措施: Usual Care (Other)
结局指标
主要结局
Change in postpartum depression symptoms
时间窗: Screening, Baseline, 3 months
Participants will take the Edinburgh Postnatal Depression Scale (EPDS) at screening, baseline and at 3 months to assess changes in mental health and depressive symptoms. This is reported on a scale of 0-30; a higher score indicates a higher likelihood of postpartum depression.
Alcohol use test results
时间窗: Baseline, Weekly, 3 months
Participants' alcohol use will be monitored and assessed with urine drug tests at baseline, 2x weekly throughout the duration of the 6-week intervention, and at 3 months.
Change in alcohol use screening status
时间窗: Screening, Baseline, 3 months
Participants will take the Alcohol Use Disorders Identification Test (AUDIT) at the time of screening, baseline and at 3 months. This is reported on a scale of 0-40; a higher score indicates a higher likelihood of moderate to severe alcohol use.
Change in alcohol-related negative consequences
时间窗: Baseline, 3 months
Participants will take the Rutgers Alcohol Problems Index (RAPI) at baseline and at 3 months to assess changes in problems related to alcohol use. This is reported on a scale of 0-72; a higher score indicates a higher likelihood of alcohol-related negative consequences in everyday life.
Change in alcohol use
时间窗: Baseline, 3 months
Participants will take the Timeline Follow Back (TLFB) questionnaire at baseline and at 3 months to assess changes in alcohol use.
Change in reasons for drinking
时间窗: Baseline, 3 months
Participants will take the Drinking Motive Questionnaire-Revised (DMQ-R) at baseline and at 3 months to assess changes in alcohol use motivations. This is reported on a scale of 20-100; a higher score indicates stronger motivations for alcohol use.
次要结局
- Acceptability of intervention(3 months)
- Feasibility of intervention via adherence(3 months)
- Feasibility of intervention via retention(3 months)