Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

University of Pennsylvania

Status: Invitation-only

Conditions: Sleep Initiation and Maintenance Disorders; Pregnancy Related

Treatments: Behavioral: Sleep Hygiene; Behavioral: Assisted Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05530863

848419

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Sleep Hygiene

Active Comparator group

Description:

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

Treatment:

Behavioral: Sleep Hygiene

ART and Sleep Hygiene

Experimental group

Description:

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

Treatment:

Behavioral: Sleep Hygiene

Behavioral: Assisted Therapy