Reaching Calm: A Digital Intervention to Prevent Perinatal Anxiety Disorders
Reaching Calm Pilot (K23)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires, Interviews
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether Reaching Calm, a program using text messages and a website, can help prevent anxiety during or after pregnancy. It is for pregnant adults with mild to moderate anxiety. Researchers will compare practices offering the program with those giving usual care and check how easy the program is to use.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Get pregnancy care at a practice taking part in the study.
- Have mild to moderate anxiety, with a score of 5–15 on the GAD-7 anxiety survey.
- Be less than 32 weeks pregnant.
- Have started Reaching Calm if you are in the group offered the program.
Who can't join
- Not pregnant.
- Unable to take part in a 60-minute interview.
- Not willing to have your voice recorded.
- Have a GAD-7 anxiety score below 5 or 15 or higher. The listing gives conflicting rules for a score of 15; ask the study team.
- Unable to give consent to join the study.
- Not yet an adult.
- Be a prisoner.
- Do not speak English.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Study sites (1)
MA
- UMass Memorial Medical Group - Montachusett Women's Health · Leominster, MA 01453Carolyn Friedhoff Alvarez · Study contactMore trials in Leominster