Reducing Health Disparities for Black Women in the Treatment of Insomnia
Reducing Health Disparities for Black Women in the Treatment of Insomnia
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.
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.
Inclusion Criteria:

 1. Participants in the Black Women's Health Study (BWHS) with clinically elevated
 symptoms of insomnia previously reported on a BWHS questionnaire.

 2. Access to a computer or tablet and internet access

 Exclusion Criteria:

 1. Intention to change use pattern of prescribed or over-the-counter sleep aid

 2. 1 or more unrelated sleep disorders

 3. Employed in a position where sleep restriction may endanger others' lives

 4. Active shift work employment

 5. Untreated, current, and/or severe psychiatric condition

 6. Consume 14 or more alcoholic drinks/week

 7. Unstable or acute medical condition