Reducing Health Disparities for Black Women in the Treatment of Insomnia
Study Details
Study Description
Brief Summary
Black women are at a higher risk of developing insomnia and insomnia has profound physical and psychological health consequences. There is a proven, non-pharmacological, treatment for insomnia for the general population 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 insomnia therapies over a 6 month follow-up period. This study aims to provide the much needed evidence to help Black women make informed decisions regarding treatment for their insomnia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Eligible Black Women's Health Study (BWHS) participants who report symptoms of insomnia compatible with clinical insomnia on the 2015 BWHS questionnaire will be randomly selected to receive information that will inform them of the opportunity to participate in a free program designed to address their sleep problems. These subjects will then be directed to an Insomnia Study Website which will provide information about the study and directions on how to complete an online screening questionnaire for those interested in participating. Reminders will be sent to these selected women to encourage participation.
Once interested women submit the screening questionnaire, an internal assessment will be carried out to see if potential participants are eligible. Those determined to be ineligible will be sent a thank you letter and informed that they were not selected for this trial. Those who meet the qualifications for the study will be directed to the informed consent form with a note indicating that a member of the study team will call them within several days at a time they indicated would be convenient for them. The study team member will then call each eligible subject and review with her, over the phone, each section of the consent form. A verbal acknowledgement of consent, or non-consent, will be recorded in the study database.
Once women have been verbally consented, they will be instructed on the use of the web programs and, completion of online sleep logs. Privacy concerns will be addressed. Pre-intervention (baseline), post-intervention, and 6-month assessment questionnaires, including the Insomnia Severity Index (ISI) will be administered pre-intervention, post-intervention and 6 months later. After the pre-intervention questionnaires and sleep logs are completed, participants will be randomized to 1 of 3 groups: usual care (sleep hygiene information), Sleep Healthy Using the Internet (SHUTi - a cognitive behavioral therapy for insomnia (CBT-I) program), or SHUTi modified for Black women. Participants randomized to usual care (also called sleep hygiene or sleep information) will use a website that discusses ways to improve behaviors and environments that can affect sleep. This material is also included in the other 2 treatments but is presented in a different way. Participants using the usual care may log in as often as they like and there are no time requirements. Participants randomized to SHUTi or modified SHUTi will use a web program that has six modules called Cores. Participants will log in to the six modules of their assigned treatment program over a 6 to 8-week period. Cores are completed one at a time in order. Each Core is expected to take 45 to 60 minutes to complete. Each Core contains information and exercises designed to help change behaviors and thoughts that can contribute to sleep problems.
Nine weeks after completing the initial pre-intervention questionnaire, all participants will be asked to complete another questionnaire about their sleep and health, which includes the ISI. Following completion of the questionnaire, participants will be asked to complete 10 sleep diaries. Six months later, participants will be asked again to complete a questionnaire that includes the ISI, followed by completion of 10 sleep diaries.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Usual care (sleep hygiene) A web-based program that presents ways to improve behaviors and environments that can affect sleep. |
Behavioral: Usual care
A woman assigned to usual care receive access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
Other Names:
|
| Active Comparator: SHUTi (Sleep Healthy Using the Internet) SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I) |
Behavioral: SHUTi
A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
Other Names:
|
| Active Comparator: modified SHUTi (SHUTi modified for Black women) The CBT-I instrument tailored for Black women. |
Behavioral: modified SHUTi
A woman assigned to modified SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in sleep difficulties assessed by the Insomnia Severity Index [baseline, 6 months]
A change in sleep difficulties will be assessed by using the ISI scale (Insomnia Severity Index). The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by sleep difficulties. A 5-point Likert scale (0 = none; 4 = very severe) is used to rate each item, with total scores ranging from 0 to 28. A higher total score indicates more severe sleep difficulties.
Secondary Outcome Measures
- Total Time in Bed (TIB) [baseline, 6 months]
Change in Total Time in Bed (TIB) - the total amount of time in bed measured in minutes.
- Sleep Onset Latency (SOL) [baseline, 6 months]
Change in Sleep Onset Latency (SOL) - the amount of time it takes to fall asleep measured in minutes.
- Wake After Sleep Onset (WASO) [baseline, 6 months]
Change in Wake after Sleep Onset (WASO) - periods of wakefulness after falling asleep measured in minutes.
- Early Morning Awakening (EMA) [baseline, 6 months]
Change in Early Morning Awakening (EMA) - a final morning awakening that is earlier than expected measured in minutes.
- Total Sleep Time (TST) [baseline, 6 months]
Change in Total Sleep Time (TST) - the amount of time spent asleep in bed, measured in minutes. Total sleep time is calculated by subtracting SOL, WASO and EMA from total time in bed (TIB).
- Sleep Efficiency (SE) [baseline, 6 months]
Change in Sleep Efficiency (SE) - the percentage of time spent asleep while in bed. It is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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:
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Intention to change use pattern of prescribed or over-the-counter sleep aid
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1 or more unrelated sleep disorders
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Employed in a position where sleep restriction may endanger others' lives
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Active shift work employment
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Untreated, current, and/or severe psychiatric condition
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Consume 14 or more alcoholic drinks/week
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Unstable or acute medical condition
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Slone Epidemiology Center | Boston | Massachusetts | United States | 02118 |
Sponsors and Collaborators
- Boston University
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Lynn Rosenberg, ScD, Senior Epidemiologist, Professor of Epidemiology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-37156
- AD-2017C1-6314