Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

N/AEnrolling By InvitationNCT05530863

University of Pennsylvania20 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Sleep Initiation and Maintenance Disorders Pregnancy Related

Interventions

Assisted TherapyBEHAVIORAL

The participant will receive coaching calls and support

Sleep HygieneBEHAVIORAL

Standard Sleep Hygiene instructions.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: 30 days

Data from ClinicalTrials.gov

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