N/A
Completed N=333
Reducing Health Disparities for Black Women in the Treatment of Insomnia
Source: ClinicalTrials.gov NCT03613519 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Change in Sleep Difficulties Assessed by the Insomnia Severity Index — -3.6; -10.0; -9.3 score on a scale
Summary
Black women are at a higher risk of developing insomnia than other women and insomnia has profound adverse physical and psychological health consequences. There is an internet-delivered treatment program for insomnia that has been shown to be effective in White individuals but there is little evidence of the effectiveness of this treatment among Black women. The goal of this study is to conduct a comparative effectiveness trial of three online insomnia therapies after a 6 month follow-up period--a cognitive behavioral therapy for insomnia (CBT-I) called SHUTi (Sleep Healthy Using the Internet), SHUTi modified for Black women (SHUTi-BWHS), and patient education (PE) (usual treatment). This study aims to provide the much needed evidence to help Black women make informed decisions regarding treatment for their insomnia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Sleep Difficulties Assessed by the Insomnia Severity Index |
-3.6; -10.0; -9.3 | — |
| SECONDARY Change in Sleep Onset Latency (SOL) |
-7.0; -20.2; -17.7 | — |
| SECONDARY Change in Wake After Sleep Onset (WASO) |
-7.2; -17.6; -19.7 | — |
| SECONDARY Change in Total Sleep Time (TST) |
0.5; 0.8; 0.3 | — |
| SECONDARY Change in Sleep Efficiency (SE) |
4.3; 12.3; 11.4 | — |
| SECONDARY Completion of All 6 Cores/Modules |
64.8; 78.2 | — |
Eligibility Criteria
Inclusion Criteria
- Participants in the Black Women's Health Study (BWHS) with clinically elevated symptoms of insomnia previously reported on a BWHS questionnaire.
- Access to a computer or tablet and internet access
Exclusion Criteria
- Intention to change use pattern of prescribed or over-the-counter sleep aid
- 1 or more untreated sleep disorders
- Employed in a position where sleep restriction may endanger others
- Active shift work employment
- Untreated, current, and/or severe psychiatric condition
- Consume 14 or more alcoholic drinks/week
- Unstable or acute medical condition
Data sourced from ClinicalTrials.gov (NCT03613519). 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.