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Enrolling by Invitation

NCT Number: NCT05530863

Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

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

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Pregnancy Related Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Assisted Therapy

Behavioral

The participant will receive coaching calls and support

Sleep Hygiene

Behavioral

Standard Sleep Hygiene instructions.

Primary outcomes

  1. PSQI, Sleep Quality

    Time frame: 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).

  2. Total Wake Time, Sleep Diary

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 7, 2022
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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