Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

NCT05530863 | Enrolling By Invitation

• 1 other identifier: 848419
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Initiation and Maintenance Disorders; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Sleep Hygiene

ACTIVE COMPARATOR

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

Behavioral: Sleep Hygiene

ART and Sleep Hygiene

EXPERIMENTAL

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

Behavioral: Assisted Therapy; Behavioral: Sleep Hygiene

Interventions

Assisted Therapy BEHAVIORAL

The participant will receive coaching calls and support

ART and Sleep Hygiene

Sleep Hygiene BEHAVIORAL

Standard Sleep Hygiene instructions.

ART and Sleep Hygiene; Sleep Hygiene

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nalaka Gooneratne, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: September 7, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)