Results Summary
What was the research about?
People with insomnia have a hard time falling asleep, staying asleep, or both. Black women are among those most likely to have insomnia. Insomnia can affect people’s overall health and daily lives.
Cognitive behavioral therapy, or CBT, is an effective treatment for insomnia. In CBT, patients learn to change patterns of thinking and behavior. With online programs, more people can access CBT.
In this study, the research team compared three online approaches on how well they improved insomnia among Black women:
- The SHUTi program. Women took an online CBT program with six sessions, each lasting 45 to 60 minutes. Topics included sleep behaviors and beliefs. The program included information, stories, and advice to improve sleep. Women also completed an online sleep diary each day and received automated advice.
- The SHUTi-BWHS program. Women took a version of the online SHUTi CBT program that had been revised with characters and storylines for Black women. Women also completed the daily sleep diaries and received automated advice.
- Patient education. Women had access to a website with information about insomnia and good sleep practices.
The research team also looked at how much and how well women slept, their attitudes about sleep, and their sleep behaviors.
What were the results?
Six months after treatment, women in all three approaches showed improvements in:
- Insomnia
- How much and how well they slept
- Sleep behaviors and attitudes
Compared with women receiving patient education, women in SHUTi and SHUTi-BWHS showed more improvement in these sleep outcomes. Women in SHUTi and SHUTi-BWHS were similar in how much they improved.
Physical health improved for women in both SHUTi and SHUTi-BWHS, but not for women receiving patient education. Mental health didn't improve for women in any of the groups.
Women in SHUTi-BWHS were more likely to complete the program than women in SHUTi. Those who completed either program saw greater improvements than those who didn't complete a program.
Who was in the study?
The study included 333 Black women with insomnia. The average age was 59 years. All women were in the Black Women’s Health Study, or BWHS. BWHS is a long-term study of Black women from across the United States.
What did the research team do?
The research team assigned women by chance to one of the three approaches. Women took surveys about sleep habits and attitudes at the start of the study and again nine weeks and six months later.
A patient with insomnia, a patient advocate, and a woman in BWHS—all Black women—worked with the research team to revise SHUTi for Black women.
What were the limits of the study?
All women in this study were in the BWHS and all had internet access; results may differ for other women. Future studies could find out if SHUTi-BWHS works as well for Black women who aren’t in the BWHS.
How can people use the results?
Black women and their doctors can use these results when considering ways to treat insomnia.
Professional Abstract
Objective
To compare the effectiveness of an online cognitive behavioral therapy (CBT) program, with or without tailoring for Black women, versus online patient education on improving insomnia among Black women
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 333 Black women with insomnia from the Black Women’s Health Study (BWHS), a U.S. based longitudinal cohort study of 59,000 Black women that began in 1995 |
| Interventions/ Comparators |
|
| Outcomes |
Primary: insomnia Secondary: quality and quantity of sleep (sleep efficiency, sleep quality, sleep latency [time spent in bed before falling asleep], wake after sleep onset [time in bed spent awake after having fallen asleep], time in bed, and total sleep time), sleep hygiene (routines to promote better sleep), attitudes and beliefs about sleep, and mental and physical health |
| Timeframe | 35-week follow-up for primary outcome |
This single-blind randomized controlled trial compared the effectiveness of three online treatments on improving insomnia symptoms, sleep quality and quantity, and sleep-related behaviors and attitudes among Black women. Researchers randomly assigned participants to one of three groups:
- SHUTi. Researchers asked participants to complete six online CBT modules addressing maladaptive sleep behaviors and beliefs, sleep restriction, stimulus control, sleep hygiene, cognitive therapy, and relaxation exercises. Each module included educational materials, stories, and advice and took about 45–60 minutes to complete.
- SHUTi-BWHS. Researchers asked participants to complete SHUTi modules adapted to include Black characters and stories with relevance to Black women.
- Patient education. Participants received access to a website with information about sleep problems and good sleep practices.
Participants in the SHUTi and SHUTi-BWHS groups also submitted a daily sleep diary and received automated recommendations for improved sleep.
The study included 333 women with insomnia participating in the Black Women’s Health Study (BWHS). The average age was 59.
Participants completed online surveys about sleep quality, habits, and attitudes at baseline, nine weeks following assignment to treatment, and six months later.
A patient with insomnia, a patient advocate, and a BWHS participant —all Black women—worked with researchers to help adapt SHUTi for Black audiences.
Results
Six months after treatment ended, all three groups showed improvements in insomnia (p<0.0001), quality and quantity of sleep (all p<0.05), sleep hygiene (p<0.0001), and attitudes and beliefs about sleep (p<0.0001). Physical health improved for both SHUTi groups (both p<0.001) but not the patient education group, and mental health did not significantly change across the three groups.
The SHUTi and SHUTi-BWHS groups showed similar improvements, and both had greater improvements than the patient education group for:
- Insomnia (both p<0.0001)
- All measures of sleep quality and quantity (both p<0.01) except total sleep time
- Sleep hygiene (both p<0.001)
- Attitudes and beliefs about sleep (both p<0.0001)
Women in SHUTi-BWHS were more likely to complete the program than women in SHUTi (78.2 % versus 64.8%; p<0.001). Those who completed either program saw greater improvements than those who did not complete a program across multiple outcomes, including insomnia (p=0.0018), sleep efficiency (p=0.0001), and sleep quality (p<0.0001).
Limitations
All participants were part of BWHS and had internet access. Results may differ for people who are not enrolled in the study or did not have internet access.
Conclusions and Relevance
Black women in both online CBT programs saw greater improvements in insomnia and other sleep-related factors than those in the patient education program. Participants assigned to the CBT program tailored for Black women were more likely to complete their program than those assigned to the standard CBT program.
Future Research Needs
Future studies could examine if SHUTi-BWHS is effective among Black women who are not part of the BWHS.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked the researchers to discuss future insomnia research for minority populations, particularly around cultural adaptation of interventions. The researchers acknowledged that cultural adaptations for hard-to-reach populations could be done. They were struck by the limited awareness among practitioners and patients that nonpharmacological treatments for insomnia, particularly cognitive behavioral therapy for insomnia, were readily available. The researchers added language to the future research section of the discussion regarding this problem.
- The reviewers noted that a potential barrier to using the intervention was using diaries to track sleep. The researchers acknowledged that filling out sleep diaries could be a barrier to people using this treatment. They included this consideration, along with potential discomfort with online treatments, in the limitations section of the report.