Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05530863
Status
Enrolling By Invitation

Conditions

  • Pregnancy Related
  • Sleep Initiation and Maintenance Disorders

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Assisted Therapy — BEHAVIORAL
    The participant will receive coaching calls and support
  • Sleep Hygiene — BEHAVIORAL
    Standard Sleep Hygiene instructions.

Study Details

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

Key Dates

Start date
Apr 1, 2022
Status verified
Dec 2025
Primary completion
Sep 27, 2026
Completion
Sep 27, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Experimental: ART and 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 Measure

PSQI, Sleep Quality [ Time Frame: 30 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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