Reducing Health Disparities for Black Women in the Treatment of Insomnia

Boston University

Status: Completed

Conditions: Insomnia

Treatments: Behavioral: modified SHUTi (i.e., SHUTi-BWHS); Behavioral: Patient education; Behavioral: SHUTi

Study type: Interventional

Funder types: Other

Identifiers

NCT03613519

H-37156

AD-2017C1-6314 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Eligible Black Women's Health Study (BWHS) participants who completed the Insomnia Severity Index(ISI) on the 2015 BWHS questionnaire with a score compatible with insomnia disorder 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. They 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, post-intervention, and 6-month assessment questionnaires, including the Insomnia Severity Index (ISI) will be administered pre-intervention (Time 1), post-intervention 9 weeks after Time 1 (Time 2), and 6 months later (Time 3). After the pre-intervention questionnaires and sleep logs are completed, participants will be informed of their treatment which was selected at random from the three online treatments: SHUTi -BWHS, SHUTi, and patient education (PE) (also called sleep hygiene or sleep information). The PE group 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 PE website may log in as often as they like for as long as they like. Participants randomized to SHUTi-BWHS or 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 an 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, and also 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.

Enrollment: 333 patients

Sex: Female

Ages: 45 to 85 years old

Volunteers: No Healthy Volunteers

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 untreated sleep disorders
3. Employed in a position where sleep restriction may endanger others
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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333 participants in 3 patient groups, including a placebo group

Patient education (sleep hygiene)

Placebo Comparator group

Description:

A web-based program that presents ways to improve behaviors and environments that can affect sleep.

Treatment:

Behavioral: Patient education

SHUTi (Sleep Healthy Using the Internet)

Active Comparator group

Description:

SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)

Treatment:

Behavioral: SHUTi

modified SHUTi (SHUTi modified for Black women)

Active Comparator group

Description:

The CBT-I instrument tailored for Black women.

Treatment:

Behavioral: modified SHUTi (i.e., SHUTi-BWHS)