Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Pregnancy Related Clinical Trial

Official title:

Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05530863
• Other study ID #: 848419
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: September 27, 2026

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women

Description:

This is a randomized, 60-day research study that is evaluating the effect of a simplified behavioral relaxation intervention in pregnant and postpartum patients aimed to improve their insomnia symptoms. The investigators will be enrolling a total of 20 patients who indicate self-reported insomnia symptoms.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 27, 2026
• Est. primary completion date: September 27, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 55
• In second or third trimester of pregnancy (Gestation weeks 18-32)
• Able to speak, read and write fluent English
• Has regular access to a smartphone and/or smart tablet
• sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for =3 nights/week, must persist for at least 1 month

Exclusion Criteria:

• Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period.
• Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

Related Conditions & MeSH terms

• Pregnancy Related
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Assisted Therapy
The participant will receive coaching calls and support
• Sleep Hygiene
Standard Sleep Hygiene instructions.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSQI, Sleep Quality	Measured by a single item score, sleep quality is the measurement of how restful and restorative the sleep of an individual is. Pittsburgh Sleep Quality Index: Well- known questionnaire used to measure sleep quality in various patient groups. For overall sleep quality, the minimum score= 0 (better) and the maximum score=3 (worse).	30 days
Primary	Total Wake Time, Sleep Diary	A sleep diary will be used to gather information about the participants daily sleep pattern and schedule; gold standard of care for insomnia. This instrument will also be used to check adherence to the Gratification practice of the ART intervention. This will be administered during pre-screening and intervention.	30 days