Treatment for Insomnia During Pregnancy

Stanford University

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Behavioral: Arousal Based Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01846585

23501

R01NR013662-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.

Enrollment: 194 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
• Pregnant with gestational age between 18-32 weeks.
• Adequately fluent in English or Spanish.

Exclusion criteria

• Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
• Co-morbid psychiatric disorder
• Use of medications, herbs or other drugs with known effects on sleep
• Unstable medical conditions
• Currently engaged in psychotherapy or other treatments for insomnia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 2 patient groups

ABTI

Other group

Description:

Arousal Based Therapy for Insomnia

Treatment:

Behavioral: Arousal Based Therapy for Insomnia

CBTI

Other group

Description:

Cognitive Behavioral Therapy for Insomnia

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia