Clinical trial NCT03613519: Reducing Health Disparities for Black Women in the Treatment of Insomnia
Official title: Reducing Health Disparities for Black Women in the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Patient education
Sleep hygiene
Sleep Healthy Using the Internet (SHUTi)
Cognitive-behavioral therapy (CBT)
Black Women's Health Study
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-08-03
Enrollment: 333
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible subjects will be randomly assigned to one of the 3 intervention groups; SHUTi-BWHS, SHUTi, or patient education (PE).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Sleep Difficulties Assessed by the Insomnia Severity Index
timeFrame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Secondary outcomes:
measure: Change in Sleep Onset Latency (SOL)
timeFrame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
measure: Change in Wake After Sleep Onset (WASO)
timeFrame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
measure: Change in Total Sleep Time (TST)
timeFrame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
measure: Change in Sleep Efficiency (SE)
timeFrame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
measure: Completion of All 6 Cores/Modules
timeFrame: Time 3 (6 months after expected completion of program)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Slone Epidemiology Center at Boston University
state: Massachusetts
Study officials:
affiliation: Senior Epidemiologist, Professor of Epidemiology
name: Lynn Rosenberg, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Sleep Medicine, Harvard Medical School
name: Eric S Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou ES, Ritterband LM, Bethea TN, Robles YP, Heeren TC, Rosenberg L. Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jun 1;79(6):538-549. doi: 10.1001/jamapsychiatry.2022.0653.