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Behavioral Intervention

Behavioral Strategies to Improve Sleep for Expectant Mothers

N/A

Recruiting

Led By Katherine M Sharkey, MD, PhD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be over 18 years of age

Participants must speak and read English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one time measure during enrollment period, ~ 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to address the issue of disrupted sleep in pregnant and new mothers, which can have negative effects on their health and their children. Researchers will develop and test a behavioral sleep intervention using short videos

Who is the study for?

This trial is for expectant and new mothers experiencing sleep issues, including insomnia and disrupted sleep patterns. It aims to help those at risk of postpartum depression linked to poor sleep. Participants should be receiving care from direct care workers who will deliver the intervention.

What is being tested?

The study tests a behavioral sleep intervention using short videos alongside a free app designed to improve sleep hygiene in perinatal women. The effectiveness of this training provided by direct care workers will be evaluated.

What are the potential side effects?

Since the intervention involves education about improving sleep through non-medical means, significant side effects are not anticipated. However, individual experiences may vary based on personal health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I can speak and read English or Spanish.

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I am between 18 and 45 years old.

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I can speak and read English or Spanish.

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I have trouble sleeping, with a score over 7 on the Insomnia Severity Index.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one time measure during enrollment period, ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one time measure during enrollment period, ~ 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and one time measure during enrollment period, ~ 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 Acceptability

Phase 1 Effectiveness

Phase 1 Reach

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Home VisitorsExperimental Treatment1 Intervention

The participants in Phase 1 of the proposed study are individuals who provide services to perinatal women who are at risk of postpartum depression. The investigators will recruit 35 adults ages 18 years or older who provide health, well-being, and/or mental health services/treatment to pregnant and postpartum women to participate in Phase 1 of this study. Job titles that meet inclusion criteria include nurses, nurse practitioners, family support workers, therapists, counselors, doulas, lactation consultants, childbirth educators, social workers, public health workers, midwives, and nurse midwives. The investigators will not select participants based on age, gender, sex, or racial or ethnic identity.

Group II: Expectant and New ParentsExperimental Treatment1 Intervention

Phase 2 participants will be given access to the educational materials about sleep and the investigators will collect information about their sleep. To qualify for enrollment, Phase 2 participants must be: * expectant parents OR new parents up to 1 year postpartum * 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 sleep diaries and assessments * are experiencing clinically significant sleep difficulties defined as an Insomnia Severity Index score greater than 7 The investigators will exclude potential participants who are parents whose infants will not be living in the home or who will have a nighttime caregiver

0 / 5Eligibility criteria met