Reaching Calm Pilot (K23)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Generalized Anxiety Disorder-7 (GAD-7) scale
研究概览
简要总结
The goal of this clinical trial is to find out if a digital program called Reaching Calm can help prevent anxiety in women who are pregnant. The study will offer Reaching Calm at obstetric practices where participants receive prenatal care. The study focuses on people who may be at greater risk for experiencing anxiety during or after pregnancy. The main questions this study aims to answer are:
- Is Reaching Calm easy to use and acceptable to both participants and healthcare professionals?
- Does Reaching Calm help reduce risk for anxiety among participants?
- Does personalizing the digital program help participants stay involved? Researchers will compare obstetric practices that offer Reaching Calm to those providing usual care.
Participants will:
- Receive text messages and use a web-based platform for learning about anxiety and coping strategies
- Respond to surveys about their experiences and symptoms
- Some will take part in interviews and focus groups to share their views
- Healthcare professionals will receive training on how to support the program The study will monitor how many people join, stay involved, and how the program affects their well-being. The results will help prepare for a larger study that could lead to wider use of Reaching Calm across the country.
详细描述
Perinatal anxiety disorders affect up to one in five women during pregnancy or after giving birth, leading to negative outcomes for both parents and children. Mental health conditions are the leading cause of maternal mortality in the United States, and untreated mood and anxiety disorders have significant economic and societal impact. Fewer than seven percent of those affected receive treatment. Preventing anxiety before it develops could significantly improve the health and well-being of perinatal individuals and their families.
This study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a digital intervention called Reaching Calm, designed to prevent anxiety during pregnancy. Reaching Calm is delivered through obstetric (OB) clinical settings to increase accessibility and engagement. The intervention, developed using community-engaged and user-centered design approaches, is especially tailored for perinatal individuals experiencing economic challenges. Reaching Calm consists of three integrated components:
- A brief digital Anxiety Sensitivity Intervention (ASI), delivered via text messages and a web-based interface, incorporating psychoeducation and exposure exercises to reduce anxiety sensitivity, a risk factor for anxiety and depression.
- Training for OB professionals on perinatal anxiety prevention and integration of the digital program into routine care.
- An implementation protocol to facilitate seamless integration into OB practice workflows.
The study is a pilot cluster randomized controlled trial (RCT). Four OB practices will be randomized, with two offering Reaching Calm and two continuing with Usual Care. The intervention and observation period will last approximately four months for each participant, to align with the typical prenatal care timeline and allow sufficient time for engagement with the digital program.
The study will evaluate participant outcomes via surveys and intervention implementation via surveys with obstetric practice leadership and practice chart reviews.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Receiving prenatal care at participating obstetric practice
- •Endorsed mild to moderate anxiety (GAD-7 score 5-15)
- •Currently pregnant (gestational age <32)
- •Started Reaching Calm digital intervention, if in intervention group
排除标准
- •Not pregnant
- •Unable to participate in 60-minute interview
- •Unwilling to be audio recorded
- •GAD-7 <5, or GAD-7≥15
- •Adults unable to consent (adults lacking capacity)
- •Individuals who are not yet adults (infants, children, teenagers)
- •Prisoners
- •Non-English-speaking
研究组 & 干预措施
Reaching Calm
Reaching Calm is a a multicomponent digital intervention to prevent perinatal anxiety in OB settings including a 1) digital Anxiety Sensitivity Intervention with text messages and web-based interface, 2) OB professional training, and 3) implementation protocol to integrate anxiety prevention into the OB workflow.
干预措施: Digital mental health intervention (Behavioral)
Prenatal care continues as usual
Prenatal care continues as usual
结局指标
主要结局
Generalized Anxiety Disorder-7 (GAD-7) scale
时间窗: Baseline, 4-weeks, and 8 weeks
Anxiety symptoms, scores range from 0-21 with higher scores indicating greater anxiety symptom severity
Anxiety Sensitivity Index-3 (ASI-3)
时间窗: Baseline, 4 weeks, 8 weeks
Anxiety sensitivity, scores range from 0-72 with higher scores indicating greater anxiety sensitivity
Treatment Evaluation Inventory Short Form (TEI-SF)
时间窗: 8 weeks
Acceptability, scores range from 9-45 with higher scores indicating greater acceptability
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 4 weeks, 8 weeks)
研究者
Martha Zimmermann
Assistant Professor
University of Massachusetts, Worcester