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New treatment option for Sleep
Official title The Dream Team: Testing Implementation of a Sleep Intervention for Perinatal Women Delivered by Direct Care Workers
ClinicalTrials.gov ID: NCT06737055
What this study is testing
- What it's testing
- Insufficient and disrupted sleep are rarely addressed in expectant and new mothers, despite evidence that disturbed sleep is a modifiable risk factor for negative health outcomes for mothers and their children. In this study the investigators will adapt, refine, and pilot test the implementation of a behavioral sleep intervention consisting of short videos designed to accompany a free behavioral sleep app.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Phase 1 To qualify for Phase 1 enrollment, participants must be:
- over 18 years of age;
- working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community...
- in a role where they would be expected to meet with the same client on at least 4 occasions during the perinatal period; in situations where a...
- have access to a smart phone to view the training videos, complete the assessments, and access the free CBTi Coach app; speak and read English or...
You likely can't join if
- The investigators will exclude potential participants who:
- already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching...
- those who do not have longitudinal relationships with clients (e.g., intake workers). Phase 2 Inclusion Criteria: To qualify, Phase 2 participants...
- expectant parents OR new parents up to 1 year postpartum;
- age 18 to 45 years old;
- receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1;
See the full eligibility criteria
- Phase 1 To qualify for Phase 1 enrollment, participants must be:
- over 18 years of age;
- working with expectant and new mothers in a community setting (i.e., outpatient clinic, social service agency, home visiting program, community center);
- in a role where they would be expected to meet with the same client on at least 4 occasions during the perinatal period; in situations where a team-based approach is used to provide services and a client may not see the...
- have access to a smart phone to view the training videos, complete the assessments, and access the free CBTi Coach app; speak and read English or Spanish;
- express interest in providing their clients with additional tools to manage sleep disturbances in pregnancy and the postpartum period. Phase 1
- The investigators will exclude potential participants who:
- already have certification or a specialty in perinatal sleep (e.g., therapists with formal training in CBTi, individuals with sleep coaching practices);
- those who do not have longitudinal relationships with clients (e.g., intake workers). Phase 2 Inclusion Criteria: To qualify, Phase 2 participants must be:
- expectant parents OR new parents up to 1 year postpartum;
- age 18 to 45 years old;
- receiving community-based health, well-being, and or mental health services or treatment from individuals who participated in Phase 1;
- speak and read English or Spanish;
- have access to a smart phone to view the training videos and complete the assessments;
- have clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7. Phase 2 Exclusion Criteria: The investigators will exclude potential participants whose infants will not be...
The study team makes the final eligibility decision.
Where it's taking place
- Providence, Rhode Island, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Providence, Rhode Island, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.