Sleep Initiation and Maintenance Disorders
Conditions
Brief summary
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.
Interventions
BEHAVIORALArousal Based Therapy for Insomnia
Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
BEHAVIORALCognitive Behavioral Therapy for Insomnia
Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
Sponsors
National Institute of Nursing Research (NINR)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of insomnia remission | Baseline to 30 weeks postpartum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity | Baseline to 30 weeks postpartum | — |
| Depression severity | Baseline to 30 weeks postpartum | — |
| Sleep Characteristics | Baseline to 30 weeks postpartum | Self-report measures characterizing sleep onset latency (time to fall asleep), wake after sleep onset, sleep duration. |
Countries
United States
Outcome results
None listed