Treatment for Insomnia During Pregnancy

Stanford University194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

194

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Arousal Based Therapy for InsomniaBEHAVIORAL

Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal

Cognitive Behavioral Therapy for InsomniaBEHAVIORAL

Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Rate of insomnia remission

Time frame: Baseline to 30 weeks postpartum

Secondary Outcomes

Insomnia severity

Time frame: Baseline to 30 weeks postpartum

Depression severity

Time frame: Baseline to 30 weeks postpartum

Sleep Characteristics

Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration.

Time frame: Baseline to 30 weeks postpartum

Data from ClinicalTrials.gov

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