Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders

Официальное название

Reaching Calm Pilot (K23)

Обзор

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.

Подробное описание

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.

A subset of participants will participate in interviews for more in-depth feedback, and a subset of professionals will join focus groups. Micro-randomization within participants will be used to evaluate whether personalization features (such as tailored content and support resources) increase engagement with the digital intervention. The extended RE-AIM implementation science framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will guide evaluation.

Findings from this pilot study will inform preparation and design of a larger-scale hybrid effectiveness-implementation trial of Reaching Calm. This work aims to create scalable, accessible, and effective solutions to prevent perinatal anxiety.

Вмешательства

• Поведенческое Digital mental health intervention
  Reaching Calm is a digital intervention designed to prevent anxiety in pregnant patients. It includes: (1) a digital Anxiety Sensitivity Intervention delivered via text messages and web-based psychoeducation and exposure exercises; (2) training for obstetric (OB) professionals to support anxiety prevention and program integration; and (3) an implementation protocol that adapts workflows to make Reaching Calm accessible during routine OB care. The intervention uses personalized content and resour

Первичные конечные точки

• Generalized Anxiety Disorder-7 (GAD-7) scale [Срок оценки: Baseline, 4-weeks, and 8 weeks]
• Anxiety Sensitivity Index-3 (ASI-3) [Срок оценки: Baseline, 4 weeks, 8 weeks]
• Treatment Evaluation Inventory Short Form (TEI-SF) [Срок оценки: 8 weeks]

Вторичные конечные точки (1)

• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, 4 weeks, 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Zimmermann M, Yonkers KA, Tabb KM, Schaefer A, Peacock-Chambers E, Clare CA, Boudreaux ED, Lemon SC, Byatt N, Tulu B. Developing personas to inform the design of digital interventions for perinatal mental health. JAMIA Open. 2024 Nov 1;7(4):ooae112. doi: 10.1093/jamiaopen/ooae112. eCollection 2024 Dec. PMID 39494447
• Zimmermann M, Yonkers KA, Tulu B, Ford L, Peacock-Chambers E, Clare CA, Boudreaux ED, Lemon SC, Byatt N. Adapting an Anxiety Sensitivity Intervention for Perinatal Mental Health: Development of a Digital Intervention. J Nerv Ment Dis. 2025 Jul 1;213(7):167-179. doi: 10.1097/NMD.0000000000001841. Epub 2025 Jul 11. PMID 40642841

Идентификаторы

NCT: NCT07458698 · STUDY00001942 · K23MH137382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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