Woman Mental Health and Addictions on Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,014
- 主要终点
- Depression symptoms
研究概览
简要总结
The study intend to achieve the following objectives
Objective 1: Develop a collaborative infrastructure among different hospital services to support research that improves the accessibility, quality, and outcomes of integrated mental health services for pregnant women for tobacco, benzodiazepine, and other substance use and/or mental health problems.
Objective 2: To evaluate the effect and test the application of computer/smart phone based tools that can assist in the goal of achieving broader effect, improved accessibility and outcomes of substance abuse/mental health services in at-risk populations.
Objective 3: Conduct research on mental health services that: (a) emphasize rapid screening and referral; (b) test the feasibility, acceptability, and effectiveness of two different comprehensive behavioral treatment approaches (standardized clinical intervention and smart phone/computer-based intervention) for pregnant women with tobacco, benzodiazepine, and other substance use problems and mental health disorders; and (c) measure and decrease the obstetric, pediatric, and mental health consequences of these problems on the mother and child.
To achieve these objectives, investigators propose a system of evaluation and recruitment of patients in five Gynecology Departments that annually attend 3700 deliveries. A telematic intervention system based on a platform that we have used for other studies (Memind) and finally a randomized blinded clinical trial of 3 branches with 100 patients per branch (usual treatment, telematic intervention and standardized clinical intervention).
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
- Double (Participant, Care Provider)
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
- •Two or more positive responses to the AC-OK-Mental Health (AC-OK MH)subscale AND
- •One or more positive responses to the AC-OK-Substance Abuse (AC-OK SA) subscale and/or reported smoking more than once a month AND
- •No use of specialized services, defined as not having an appointment in the following month and have not seen a clinician in the past three months and
- •if the Paykel Suicide Scale was administered, they answered NO to questions 4 and 5.
排除标准
- •Had received a diagnosis of psychotic or bipolar-related disorders or
- •Lacked capacity to consent, as determined by not being able to answer questions of the study purpose or process.
结局指标
主要结局
Depression symptoms
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: - Patient Health Questionnaire (PHQ-9) which addresses the nine DSM-IV diagnostic criteria for major depressive disorder. The range of scores goes from 0 to 27 points depending on the severity
Anxiety symptoms
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: - General Anxiety Disorder 7-item screener (GAD-7) for anxiety . The range of scores goes from 0 to 21 points depending on the severity
Post-Traumatic Stress Disorder symptoms
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: - Post-Traumatic Stress Disorder Checklist (PCL-5), a self-report measure for the 17 DSM-IV symptoms of PTSD. Scores above 33 are considered at risk.
Alcohol Use Disorders
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: Alcohol Use Disorders Identification Test (AUDIT), a screener developed by the World Health Organization (WHO). Patients with scores greater than or equal to 3 are considered at risk.
Drug Abuse Disorders
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: Drug Abuse Screening Test (DAST), a brief self-report instrument designed for drug abuse and dependence disorders detection. Patients with scores greater than or equal to 3 are considered at risk.
Smoking Dependence
时间窗: 12 months after enrollment
Changes in the following scale were measured at 2,4,8,and 12 months: Fagerström Test for Nicotine Dependence: A six item instrument that evaluates the amount of cigarette consumption, compulsion to smoke, and smoking dependence. The range of scores goes from 0 to 10 points depending on the dependence degree.
Substance use intensity
时间窗: 12 months after enrollment
At 2,4,8,and 12 months, women were asked about the number of days in the last month they used the following substances: alcohol, opioids, barbiturates, benzodiazepines, cocaine, amphetamines, cannabis, hallucinogens and inhalants
次要结局
- Child Perinatal outcomes (Arterial pH)(12 months after enrollment)
- Child Perinatal outcomes (resuscitation)(12 months after enrollment)
- Obstetric outcomes (Gestational week at birth)(12 months after enrollment)
- Obstetric outcomes (route of delivery)(12 months after enrollment)
- Obstetric outcomes (puerperal complications )(12 months after enrollment)
- Child Perinatal outcomes (Fetal birth weight)(12 months after enrollment)
- Child Perinatal outcomes (Apgar score)(12 months after enrollment)