Perinatal Mood Tracking and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26
研究概览
简要总结
New moms can be at risk for perinatal depression (PND). The New Moms Mood Tracking and Wellbeing study is investigating mood changes, risk factors for depression and anxiety and treatment response around the time of delivery. Participants will be asked to complete three sets of online surveys between week 28 gestation and week 20 after delivery, in addition to downloading an app to collect data using their smartphone sensors and brief symptom surveys every other week. Women with elevated symptoms will be eligible to participate in a treatment study. Women who are eligible for the treatment study will be randomized to one of two conditions - Perinatal Psychiatric Care or Screening and Treatment for Anxiety and Depression (STAND). In Perinatal Psychiatric Care, participants will receive appointments with psychiatry clinicians for medication management and supportive therapy. In STAND, participants will be allocated to Online therapy with Coaching or Clinical Care, which includes both psychotherapy and psychiatry appointments. Treatment can last up to 6 months and there will be treatment related assessments for the duration of the 6 months, in addition to brief symptom surveys on a regular basis. Therefore, participation can last between 24 and 52 weeks, as both time of delivery and treatment enrollment timepoint cannot be scheduled in advance.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who are between week 28 of their pregnancy and 6 months postpartum and are receiving care at a UCLA OB-GYN clinic
- •Fluent in English
- •Current endorsement of moderate or higher depression on the Edinburgh Postnatal Depression Scale (EPDS, => 11 sum score), administered by the treating OB-GYN physician or study staff
- •Not currently in individual treatment for a behavioral or emotional problem (e.g., anxiety, depression)
- •Willingness to follow study procedures
- •Willingness to participate in treatment through the study and follow all study procedures, including provide HIPAA Authorization for research
- •Has access to the internet via mobile or desktop device
排除标准
- •Are currently receiving treatment by a therapist or a psychiatrist
- •Unstable suicidality (e.g., 2 or more suicide attempts or self-injurious behaviors resulting in hospitalization in the last 6 months, combined with high ratings on self-reported negative urgency)
- •Current substance use disorder that interferes with treatment: specifically, patients meeting diagnostic criteria for Substance Use Disorder (SUD) will be eligible for inclusion only if they are able to attend sessions while not under the influence of that substance, with the exception of individuals abusing opiates or freebase cocaine, who will be excluded
- •Principal diagnosis of psychosis unrelated to depression (unipolar or bipolar)
- •Neurological conditions
- •Severe uncontrolled medical conditions (e.g., anorexia nervosa, cardiac conditions requiring continuous monitoring)
- •Cognitive impairment (e.g., developmental disability, dementia)
结局指标
主要结局
Change From Baseline in Computerized Adaptive Testing - Mental Health (CAT-MH) Scores every two weeks until Week 26
时间窗: Week 2-26
Evaluation of degree of change in depression score throughout and after defined treatment periods as measured by the CAT-MH scores. The CAT-MH uses item response theory (IRT) to select a subset of items from a pool of approximately 1000 questions to target the respondent's impairment level. It consists of five modules, which screen for a diagnosis of Major Depressive Disorder, depressive symptoms, anxiety symptoms, mania, and suicidal ideation.
次要结局
- Edinburgh Postnatal Depression Scale (EPDS-9)(Post-treatment and week 26)
研究者
Michelle Craske
Distinguished Professor
University of California, Los Angeles