N/A
Completed N=208
Research on Expecting Moms and Sleep Therapy
Source: ClinicalTrials.gov NCT02805998 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Change in Insomnia Severity Index Scale Score — -6.054945; -2.212766 units on a scale
Summary
The overarching goal is to utilize a randomized control design to examine efficacy of web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as usual alone for insomnia and depression outcomes among pregnant women with insomnia at high risk for depressive relapse/recurrence (n=208).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Insomnia Severity Index Scale Score |
-6.054945; -2.212766 | — |
| SECONDARY Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs |
8.25317; .3224638 | — |
| SECONDARY Change in Sleep Duration, as Determined by Daily Sleep Logs |
.3426204; -.0230307 | — |
| SECONDARY Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score |
-3.172414; -.1595745 | — |
| SECONDARY Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score |
-2.224719; -.0425532 | — |
| SECONDARY Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator |
-.5955056; -.2021277 | — |
Eligibility Criteria
Inclusion Criteria
- pregnant up to 28 weeks gestation,
- 18 years of age or older,
- Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia disorder as determined by the Sleep Condition Indicator (SCI) or Insomnia Severity Index (ISI) score ≥ 11
- regular access to a web-enabled computer, tablet, or smart phone.
Exclusion Criteria
- Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 15),
- self-reported bipolar disorder,
- self-reported history of psychosis,
- active suicidality defined as scoring > 1 on EPDS item 10 or report of a specific suicide plan or recent attempt,
- shift work employee,
Data sourced from ClinicalTrials.gov (NCT02805998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.