Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Not Applicable

• Conditions: Sleep Initiation and Maintenance Disorders; Pregnancy Related
• Interventions: Behavioral: Sleep Hygiene; Behavioral: Assisted Therapy

• Registration Number: NCT05530863
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-24
• Study Start: 2022-04-01
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-09-27
• Study Completion: 2026-09-27

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep Hygiene	Sleep Hygiene	This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding
ART and Sleep Hygiene	Assisted Therapy	This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding
ART and Sleep Hygiene	Sleep Hygiene	This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding

Primary Outcome Measures

Name	Time	Method
PSQI, Sleep Quality	30 days	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).
Total Wake Time, Sleep Diary	30 days	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States