Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women: A Randomized Clinical Trial

Eric S Zhou; Lee M Ritterband; Traci N Bethea; Yvonne P Robles; Timothy C Heeren; Lynn Rosenberg

doi:10.1001/jamapsychiatry.2022.0653

. 2022 Apr 20;79(6):538–549. doi: 10.1001/jamapsychiatry.2022.0653

Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women

A Randomized Clinical Trial

Eric S Zhou ^1,^2,^✉, Lee M Ritterband ³, Traci N Bethea ⁴, Yvonne P Robles ⁵, Timothy C Heeren ⁶, Lynn Rosenberg ⁵

¹Division of Sleep Medicine, Harvard Medical School, Boston, Massachusetts

²Perini Family Survivors’ Center, Dana-Farber Cancer Institute, Boston, Massachusetts

³Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia Health System, Charlottesville

⁴Cancer Prevention and Control Program, Georgetown Lombardi Comprehensive Cancer Center, Washington, DC

⁵Slone Epidemiology Center at Boston University, Boston, Massachusetts

⁶School of Public Health, Boston University, Boston, Massachusetts

Accepted for Publication: February 16, 2022.

Published Online: April 20, 2022. doi:10.1001/jamapsychiatry.2022.0653

^✉

Corresponding Author: Eric S. Zhou, PhD, Perini Family Survivors’ Center, Dana-Farber Cancer Institute, 450 Brookline Ave, Boston, MA 02215 (eric_zhou@dfci.harvard.edu).

Author Contributions: Drs Zhou and Rosenberg had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Zhou, Ritterband, Bethea, Rosenberg.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Zhou, Rosenberg.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Zhou, Robles, Heeren, Rosenberg.

Obtained funding: Zhou, Rosenberg.

Administrative, technical, or material support: Zhou, Bethea, Rosenberg.

Study supervision: Zhou, Ritterband, Rosenberg.

Conflict of Interest Disclosures: Dr Zhou has received grants from the Patient-Centered Outcomes Research Institute during the conduct of the study as well as grants from the National Cancer Institute, Jazz Pharmaceuticals, Harmony Biosciences, Children’s Cancer Research Fund, and Pedals for Pediatrics and consulting fees from MindUP (The Goldie Hawn Foundation) outside the submitted work. Dr Ritterband has received grants from the Patient Centered Outcomes Research Institute during the conduct of the study; personal fees from Pear Therapeutics and Mahana Therapeutics outside the submitted work; is a member of the Board of Directors of BeHealth Solutions; owns equity in BeHealth Solutions; has a patent for Sleep Healthy Using the Internet with royalties paid from Pear Therapeutics. Dr Bethea has received grants from the National Cancer Instiutte during the conduct of the study and personal fees from George Washington University outside the submitted work. Dr Rosenberg has received grants from the National Cancer Institute and Patient-Centered Outcomes Research Institute during the conduct of the study. No other disclosures were reported.

Funding/Support: This trial was funded by grant AD-2017C1-6314 from the Patient-Centered Outcomes Research Institute. Additionally, grant U01 CA164974 from the National Cancer Institute supports the Black Women’s Health Study infrastructure.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We are grateful for the leadership provided by members of our stakeholder team (Sanford Auerbach, Lynette Griffeth Fields, Catherine Joseph, Josephine Nash, and Tracy Trevorrow). Next, we thank Chantale Branson, MD, and Kyra Clark, MD, for their contributions to the sleep expert videos for Sleep Healthy Using the Internet–Black Women’s Health Study. Third, Patricia Simmons and Lauren Delp (Boston University, Boston, Massachusetts) were integral to the successful conduct of this study. We also thank Karen Ingersoll, Christina Frederick, Gabe Heath, Nicole Le, and the rest of the staff at the Center for Behavioral Health and Technology at the University of Virginia, Charlottesville, who helped manage the development and utilization of the interventions in this trial and oversaw all the data captured by these programs. Stakeholders were compensated an average of $500 per year during the grant funding period for their efforts. Finally, we appreciate the commitment of the participants of the Black Women’s Health Study to improving public health.

^✉

Corresponding author.

PMCID: PMC9021979 PMID: 35442432

Key Points

Question

How can insomnia disorder be treated effectively in Black women over the internet, and how can intervention engagement be increased?

Findings

In this randomized clinical trial including 333 Black women, participants receiving both a standard internet-delivered cognitive behavioral intervention for insomnia and a version tailored for Black women reported significantly greater insomnia improvement compared with those receiving sleep education alone. Participants were more likely to complete the full intervention if they received the tailored program, with intervention completion associated with greater insomnia improvement.

Meaning

In this study, known sleep health disparities facing Black women in the US were addressed with an evidence-based treatment, and engagement was increased using a culturally adapted intervention.

This randomized clinical trial compares the efficacy of a standard version of an internet-delivered cognitive behavioral therapy for insomnia program, a culturally tailored version, and a sleep education control at improving insomnia symptoms among Black women with insomnia disorder.

Abstract

Importance

Black women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population.

Objective

To compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms.

Design, Setting, and Participants

In this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women’s Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study.

Interventions

Participants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep.

Main Outcomes and Measures

The primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE.

Results

A total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: −10.0 points; 95% CI, −11.2 to −8.7; SHUTi-BWHS: −9.3 points; 95% CI, −10.4 to −8.2) than those randomized to receive PE (−3.6 points; 95% CI, −4.5 to −2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (−10.4 points [95% CI, −11.4 to −9.4] vs −6.2 points [95% CI, −8.6 to −3.7]).

Conclusions and Relevance

In this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep.

Trial Registration

ClinicalTrials.gov Identifier: NCT03613519

Introduction

Insomnia is associated more frequently with psychiatric disorders than any other medical illness,¹ contributes to an increased risk of cardiovascular disease,² obesity,³ and home, motor vehicle, and workplace unintentional injuries,⁴ and results in substantially poorer quality of life.⁵ Women are up to 40% more likely to have insomnia disorder during their lifetime than men and are more likely to experience multiple insomnia symptoms.^6,7 In one national survey, 67% of women reported at least a few nights of sleep difficulty in the past month.⁸

Poor sleep has also been shown to disproportionately affect Black individuals.^9,10 For example, Black adults in the US have shorter total sleep duration, experience lighter and more fragmented sleep,^{10,11,12,13,14,15,16} and report worse sleep quality compared with other racial groups.^14,17,18,19 Consistent with this literature, we demonstrated that insomnia is a major problem for participants in the Black Women’s Health Study (BWHS), a longitudinal cohort of Black women from across the US.²⁰ Among 26 139 BWHS participants, approximately 45% had insomnia symptoms, and 15% had symptoms consistent with insomnia disorder.²⁰

The American Academy of Sleep Medicine (AASM)²¹ and American College of Physicians²² recommend cognitive behavioral therapy for insomnia (CBT-I) as criterion-standard treatment for insomnia. CBT-I is a multicomponent intervention that addresses the maladaptive sleep behaviors and beliefs maintaining insomnia disorder, incorporating sleep restriction (limiting time in bed to reflect sleep duration), stimulus control (avoidance of nonsleep activities in bed), sleep hygiene (implementing positive sleep behaviors and improving social/environmental factors), cognitive therapy (reframing negative thoughts surrounding sleep and its daytime impact), and relaxation exercises.²³ Because there are few CBT-I–trained clinicians and state licensure regulations often prohibit cross-border practice, treatment availability is a challenge.^24,25 Internet-delivered CBT-I programs (eg, Sleep Healthy Using the Internet [SHUTi]) can increase access. The SHUTi program is an automated intervention that has been studied across multiple patient populations around the world, with consistent data demonstrating its effectiveness.^{26,27,28,29,30} While internet-delivered interventions offer better access to evidence-based care, patient adherence with automated programs that are designed to change health behaviors can be an issue.^31,32 In a prior SHUTi trial, Black women were less likely than women of other races and ethnicities to initiate and continue with treatment. This difference is critical, as SHUTi participant engagement was associated with how much insomnia symptoms improved.³³

The development of a culturally tailored intervention may be the key to better engaging racial and ethnic minority patients with proven insomnia treatment.^34,35 Despite increasing awareness of the importance of the sociocultural context in understanding racial and ethnic sleep health disparities,³⁶ to our knowledge, there has not previously been a cultural adaptation of CBT-I for any racial or ethnic minority group.³⁷ This limitation is reflected in a recent American Academy of Sleep Medicine systematic review and meta-analysis, which concluded that racial and ethnic minority groups have been largely overlooked in CBT-I trials.³⁸ Other meta-analyses do not discuss the effect of race and ethnicity on intervention efficacy,^39,40 with participant data on race and ethnicity often not even reported.⁴¹ The failure to learn how to engage underserved racial and ethnic minority populations with CBT-I and establish the effectiveness of sleep treatments in these populations is a health inequity requiring attention.^9,42

This report describes, to our knowledge, the first published trial of an insomnia program designed for Black women. We collaborated with a stakeholder group to develop a SHUTi adaptation including elements hypothesized to better engage Black women while retaining the core CBT-I components which make SHUTi effective. We then conducted a randomized clinical trial among BWHS participants comparing the efficacy of SHUTi, a version of SHUTi adapted specifically for Black women, and patient education (PE) about sleep. We hypothesized that the SHUTi-BWHS program would be more effective at decreasing insomnia symptom severity compared with the SHUTi program and compared with PE. We also evaluated the extent to which the tailored SHUTi-BWHS program affected user engagement.

Methods

Study Design

We conducted a single-blind (participants), parallel randomized clinical trial among Black women with insomnia disorder, using an equal allocation ratio. Participants were recruited from the BWHS, a national cohort study that enrolled 59 000 Black women from across the US in 1995.⁴³

The study was approved by the Boston University Medical Campus Institutional Review Board as well as the institutional review boards of the participating institutions. Oral informed consent was obtained from all participants. The trial protocol can be found in Supplement 1. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Participants

Between October 2019 and May 2020, invitation letters were sent to BWHS participants selected at random from those with an ISI score of 15 points or greater (reflecting clinical insomnia⁴⁴) in the 2015 BWHS questionnaire and who had completed the most recent (2019) questionnaire. Of 3071 women to whom invitations were sent, 1010 completed an online eligibility questionnaire. Based on responses, 490 were excluded (Figure). As some women reported more than 1 reason, the total sums to more than the total number of women. Among those eligible, 333 women enrolled and were randomized. The randomized participants differed from the 677 who completed the eligibility questionnaire but were not enrolled on level of education (significantly more enrolled participants had completed postgraduate education [147 of 333 vs 213 of 667; P < .001]) but did not differ with respect to age or insomnia symptom severity. Participants were randomized individually using a table populated with numbers from 1 to 3 that was generated using the randomization feature of an SQL server. Enrollment occurred from October 2019 to June 2020, with all data collected by March 2021.

Figure. — BWHS indicates Black Women’s Health Study; SHUTi, Sleep Healthy Using the Internet.

Study Interventions

The SHUTi program is a 6-session program (45 to 60 minutes per session) delivered over 6 to 9 weeks. SHUTi incorporates all core elements of CBT-I, tailoring content based on each participant’s reported baseline sleep function, treatment adherence, and sleep progress. The version of SHUTi used in this trial was evaluated among adults 55 years and older.⁴⁵

The adapted version of SHUTi (SHUTi-BWHS) was developed over 1 year of collaboration with stakeholders, which included 3 Black women (a BWHS participant, a Black woman with a history of insomnia, and a Black woman with participatory research experience), a sleep physician from a medical center where more than 70% of the patient population are from racial and ethnic minority groups, a sleep researcher serving in a leadership role at a national health organization, and study investigators. In addition, 2 Black women who served on the project team were intimately involved in the adaptation process. All stakeholders were tasked to individually complete the standard SHUTi program with the goal of identifying content that could improve the engagement of Black women with the intervention. After completion of each session, interviewers conducted a semistructured interview with each stakeholder asking their views of the strengths and weaknesses of that session as it related to program engagement for a Black woman. Interviews were recorded and transcripts were analyzed and summarized by a doctoral-level qualitative researcher according to standard comprehensive, thematic qualitative analysis methods. A summary of the identified themes was then presented to the stakeholder group, followed by a discussion among group members about the adaptations that needed to be made. First, stakeholders advised the overhaul of all visual content to include only Black men and women. To address this, we replaced still photographs and filmed new videos with Black actors for the patient vignettes. In addition, we filmed videos of Black female sleep physicians who served as the sleep experts in the program content. Second, stakeholders recommended the introduction of didactic content that spoke to the cultural and social contexts in which insomnia occurs for Black women. Examples of didactic content modifications included a discussion of how to successfully implement stimulus control in a crowded living environment and ways to address neighborhood noise levels.

PE material about sleep tends to reflect usual care and served as the active control condition. The PE website focused on symptoms of insomnia, the impact, prevalence, and causes of insomnia, considerations on when to see a doctor, and basic lifestyle, environmental, and behavioral strategies to improve sleep; it has been used extensively in prior SHUTi trials.²⁷

Study Measures

Study assessments were conducted at time 1 (baseline), time 2 (postintervention; approximately 9 weeks after time 1), and time 3 (long-term follow-up; approximately 6 months after time 2). Participants were compensated $25 for completion of questionnaires and diaries at time 1, $50 at time 2, and $75 at time 3.

Sleep-Related Outcomes

The primary study outcome was insomnia severity, assessed with the ISI,⁴⁴ a 7-item questionnaire well validated in insomnia research in multiple patient populations, including via online administration and in Black women.^46,47,48,49 Total scores range from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms.⁵⁰ Secondary sleep outcomes were collected via online sleep diaries, which include time taken to fall asleep (sleep onset latency), wake after sleep onset, total sleep, total time in bed, and sleep efficiency (total sleep divided by total time in bed, multiplied by 100). Additionally, the Pittsburgh Sleep Quality Index (PSQI),⁵¹ a 19-item survey assessing overall sleep quality, was a secondary sleep outcome. The PSQI has been validated extensively, including among Black women.⁵²

Covariates

Variables used to describe the study sample (Table 1) were obtained from several sources. Age, marital status, employment status, bed partners, sleep apnea diagnosis, and alcohol consumption were collected at time 1. Highest educational level achieved was obtained from the 2003 BWHS questionnaire, with all other covariate data obtained from the 2015 BWHS questionnaire.

Table 1. Characteristics of Women Randomized in the Trial^a.

Characteristic	No. (%)
	Total (N = 333)	Treatment group
	Total (N = 333)	SHUTi-BWHS (n = 110)	SHUTi (n = 108)	PE (n = 115)	P value^b
Age, mean (SD), y^c	59.5 (8.0)	59.6 (8.4)	59.9 (8.0)	59.2 (7.7)	.83
Education level^d					.44
≤12 y	23 (6.9)	6 (5.5)	10 (9.3)	7 (6.1)
Some college	73 (21.9)	22 (20.0)	26 (24.1)	25 (21.7)
College degree	92 (27.6)	28 (25.5)	25 (23.2)	39 (33.9)
≥Graduate degree	145 (43.5)	54 (49.1)	47 (43.5)	44 (38.3)
Marital status^e					.55
Married or living as married	128 (38.4)	46 (41.8)	42 (38.9)	40 (34.8)
Single, separated, divorced, or widowed	205 (61.6)	64 (58.2)	66 (61.1)	75 (65.2)
Living arrangement					.38
Live alone	125 (37.5)	39 (35.4)	37 (34.3)	49 (42.6)
Live with others	208 (62.5)	71 (64.6)	71 (65.7)	66 (57.4)
Bed partner					.42
No bed partner	216 (64.9)	66 (60.0)	72 (66.7)	78 (67.8)
Bed partner	117 (35.1)	44 (40.0)	36 (33.3)	37 (32.2)
Geographic region					.29
Northeast	62 (18.6)	24 (18.6)	23 (21.3)	15 (13.0)
South	142 (42.6)	44 (40.0)	45 (41.7)	53 (46.1)
Midwest	56 (16.8)	14 (12.7)	17 (15.7)	25 (21.7)
West	73 (21.9)	28 (25.5)	23 (21.3)	22 (19.1)
Employment status^e					.55
Currently employed	203 (61.0)	63 (57.3)	66 (61.1)	74 (64.4)
Not currently employed	130 (39.0)	47 (42.7)	42 (38.9)	41 (35.7)
Parity^f					.97
Nulliparous	85 (25.5)	29 (26.4)	27 (25.0)	29 (25.2)
Parous	248 (74.5)	81 (73.6)	81 (75.0)	86 (74.8)
Menopause status					.82
Premenopausal	128 (38.4)	43 (39.1)	39 (36.1)	46 (40.0)
Postmenopausal	205 (61.6)	67 (60.9)	69 (63.9)	69 (60.0)
Alcoholic drinks per week, mean (SD)^e	1.4 (2.2)	1.1 (1.9)	1.8 (2.6)	1.2 (2.1)	.03
Smoking history					.14
Current	20 (6.0)	5 (4.6)	10 (9.3)	5 (4.4)
Past	78 (23.4)	32 (29.1)	18 (16.7)	28 (24.4)
Never	235 (70.6)	73 (66.4)	80 (74.1)	82 (71.3)
Body mass index^g					.21
<25	76 (22.8)	33 (30.0)	25 (23.2)	18 (15.7)
25-29	84 (25.2)	25 (22.7)	28 (25.9)	31 (27.0)
≥30	154 (46.2)	44 (40.0)	51 (47.2)	59 (51.3)
Unknown	19 (5.7)	8 (7.3)	4 (3.7)	7 (6.1)
Hypertension history					.85
No	190 (57.1)	62 (56.4)	64 (59.3)	64 (55.7)
Yes	143 (42.9)	48 (43.6)	44 (40.7)	51 (44.3)
Type II diabetes					.85
No	278 (83.5)	90 (81.8)	91 (84.3)	97 (84.4)
Yes	55 (16.5)	20 (18.2)	17 (15.7)	18 (15.7)
Ever medication-treated depression					.06
No	190 (57.1)	53 (48.2)	64 (59.3)	73 (63.5)
Yes	143 (42.9)	57 (51.8)	44 (40.7)	42 (36.5)
Current medication-treated depression					.62
No	306 (91.9)	100 (90.9)	98 (90.7)	108 (93.9)
Yes	27 (8.1)	10 (9.1)	10 (9.3)	7 (6.1)
Sleep apnea (actively treated)^e					.06
No	316 (94.9)	102 (92.7)	107 (99.1)	107 (93.0)
Yes	17 (5.1)	8 (7.3)	1 (0.9)	8 (7.0)

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Abbreviations: BWHS, Black Women’s Health Study; PE, patient education; SHUTi, Sleep Healthy Using the Internet.

^{^a}

Values are from the 2015 BWHS health questionnaire unless otherwise indicated.

^{^b}

P values of continuous variables calculated using analyis of variance and of categorical variables using χ² test.

^{^c}

Age in 2020.

^{^d}

Value last collected from BWHS in 2003.

^{^e}

Value from eligibility questionnaire.

^{^f}

Value last collected from BWHS in 2013.

^{^g}

Calculated as weight in kilograms divided by height in meters squared.

Statistical Analysis

Study groups are described on baseline characteristics by means and SDs for continuous characteristics and counts and percentages for categorical characteristics. For ISI (primary study outcome), factorial 3 (groups) × 3 (times) mixed-effects linear model analyses compared improvement in the treatment groups to the usual care group and to one another. Use of a linear-mixed model analysis where we treated time as a categorical factor accounted for the within-participant correlation of ISI values over time through a random effect and allowed us to include available data from participants who did not complete assessments at the second or third time points. Differences in changes in ISI scores over time between intervention groups were represented through group × time interactions, and model contrasts were used to make specific pairwise comparisons between the 3 interventions. We corrected for multiple testing of pairwise comparisons across the 3 study groups by using the Hochberg sequentially acceptive step-up procedure.^53,54 Analyses of secondary sleep outcomes paralleled the primary analyses and examined the percentage of participants who responded to treatment (a decrease of 8 or more points on the ISI from time 1 to time 3) or whose insomnia remitted (ISI score of 7 or less at time 3).⁵⁰ Percentages were compared between the SHUTi-BWHS and SHUTi arms through χ² tests. To examine the association between treatment completion and treatment effect, secondary analyses examined changes in sleep parameters from time 1 to time 3 for participants in the SHUTi-BWHS and SHUTi programs who completed all 6 sessions vs those who completed fewer through the 2-sample t test.

Primary analyses were based on all available data; however, some participants did not respond to the time 2 or time 3 assessments and the level of missing data varied across treatment group (Figure). Time 2 or time 3 assessment completers did not significantly differ from those who failed to complete that assessment on demographic (age, education), health (body mass index; calculated as weight in kilograms divided by height in meters squared), or disease-specific (baseline ISI score) variables. The 2 groups did differ on the number of intervention sessions completed, with assessment completers more likely to have finished more intervention sessions of either SHUTi-BWHS or SHUTi (mean [SD] of 5.4 [1.5] sessions) compared with noncompleters (mean [SD] of 2.2 [2.1] sessions). As this suggests that data may not be missing at random, we conducted sensitivity analyses conservatively assigning baseline values to the study’s primary outcome (ISI score) when participants were missing data. These analyses did not change the direction or significance of any of our findings.

Power calculations were conducted using Proc Power in SAS version 9.4 (SAS Institute) based on data collected from a prior SHUTi intervention trial that included a subset of Black women.²⁷ This study showed a reduction in mean (SD) Insomnia Severity Index (ISI)⁴⁴ scores from baseline to 6 months of 17.0 (4.0) points to 8.4 (5.7) points in the SHUTi group compared with 18.0 (4.0) points to 12.2 (5.6) points in a patient education (PE) group, corresponding to a Cohen d of 0.71 and a 32% difference in mean ISI score at 6 months. Powering our study at 80% to detect this moderate to large difference between any 2 of our study arms via a 2-samples t test of the mean change scores, at a pairwise P < .01 to account for multiple testing, a minimum analysis sample of 72 in each study group is needed. Conservatively estimating 28% study attrition based on previous SHUTi trials, a recruitment sample of 101 for each randomized group (303 overall) was targeted. The study was not powered to detect smaller differences between the SHUTi and SHUTi-BWHS intervention arms.

Results

A total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years (Table 1). Most were employed, parous, and postmenopausal. A total of 154 participants (46.2%) were obese (body mass index of 30 or greater), 143 (42.9%) had hypertension, 55 (16.5%) had type 2 diabetes, and 17 (5.1%) reported sleep apnea that was actively treated. Some (143 [42.9%]) had received drug treatment for depression at some point in their lives.

Changes to Sleep During the Study Period

Significant improvements from time 1 to time 3 were seen in the ISI, PSQI, and sleep diary outcomes (sleep onset latency, wake after sleep onset, sleep efficiency) for participants receiving SHUTi-BWHS and SHUTi but not for participants receiving PE (Table 2; eFigure in Supplement 2). The declines from time 1 to time 3 for the ISI total score for SHUTi-BWHS, SHUTi, and PE were 9.3, 10.0, and 3.6, respectively, with a bigger decrease indicating greater reduction in insomnia severity. Sleep quality (PSQI) decreased from time 1 to time 3 by 4.8, 5.3, and 2.0, respectively, with lower scores indicating better sleep quality. Sleep efficiency improved from time 1 to time 3 by 11.4% among SHUTi-BWHS participants, 12.2% in SHUTi participants, and 4.3% in PE participants. The changes in ISI, PSQI, and sleep diary outcomes from time 1 to time 3 were significantly greater in each of the SHUTi groups than in the PE group, while the changes in the SHUTi-BWHS and SHUTi groups did not differ from each other (Table 2).

Table 2. Changes in Sleep Parameters Over Time.

Measure	Mean sleep parameter (SE)^a			Change from time 1 to time 2				Change from time 1 to time 3				Change from time 2 to time 3
Measure	Time 1 (baseline)	Time 2 (9 wk after time 1)	Time 3 (6 mo after time 2)	Change in score^b	P value^c	P value vs PE^d	P value vs SHUTi^e	Change in score	P value^c	P value vs PE^d	P value vs SHUTi^e	Change in score	P value^c	P value vs PE^d	P value vs SHUTi^e
Insomnia Severity Index (P < .001)^f
All participants	18.8 (0.2)	12.6 (0.3)	11.1 (0.3)	−6.2	<.001	NA	NA	−7.6	<.001	NA	NA	−1.4	<.001	NA	NA
SHUTi-BWHS	18.7 (0.4)	11 (0.5)	9.4 (0.6)	−7.8	<.001	<.001	.48	−9.3	<.001	<.001	.44	−1.5	.002	.85	.85
SHUTi	18.3 (0.4)	10 (0.6)	8.4 (0.6)	−8.3	<.001	<.001	NA	−10.0	<.001	<.001	NA	−1.7	.002	.85	NA
PE	19.2 (0.3)	16.7 (0.5)	15.6 (0.5)	−2.5	<.001	NA	NA	−3.6	<.001	NA	NA	−1.1	.01	NA	NA
Sleep onset latency, min (P = .001)
All participants	42.3 (1.6)	27.5 (1.2)	27.4 (1.3)	−14.8	<.001	NA	NA	−15.0	<.001	NA	NA	−0.2	.89	NA	NA
SHUTi-BWHS	38.0 (2.7)	21.9 (2.1)	20.3 (2.2)	−16.1	<.001	.02	.14	−17.7	<.001	.01	.54	−1.6	.47	.66	.66
SHUTi	47.5 (2.7)	25.9 (2.3)	27.3 (2.4)	−21.6	<.001	<.001	NA	−20.2	<.001	.00	NA	1.4	.57	.66	NA
PE	41.6 (2.6)	34.8 (2.0)	34.5 (2.1)	−6.7	.01	NA	NA	−7.0	.01	NA	NA	−0.3	.89	NA	NA
Wake after sleep onset, min (P = .03)
All participants	39.7 (1.8)	26.4 (1.6)	24.9 (1.7)	−13.3	<.001	NA	NA	−14.8	<.001	NA	NA	−1.6	.25	NA	NA
SHUTi-BWHS	41.2 (3.2)	25.4 (2.7)	21.5 (2.9)	−15.8	<.001	.08	.80	−19.7	<.001	.01	.64	−3.9	.10	.70	.70
SHUTi	37.4 (3.2)	20.4 (2.9)	19.8 (3.1)	−17.0	<.001	.07	NA	−17.6	<.001	.04	NA	−0.6	.81	.89	NA
PE	40.5 (3.1)	33.5 (2.6)	33.3 (2.7)	−7.1	.02	NA	NA	−7.2	.01	NA	NA	−0.2	.94	NA	NA
Total sleep time, h (P = .02)
All participants	5.8 (0.1)	6.1 (0.1)	6.3 (0.1)	0.3	<.001	NA	NA	0.5	<.001	NA	NA	0.2	<.001	NA	NA
SHUTi-BWHS	6.0 (0.1)	6.0 (0.1)	6.3 (0.1)	0.1	.47	.04	.07	0.3	.003	.24	.03	0.3	.003	.34	.45
SHUTi	5.7 (0.1)	6.1 (0.1)	6.4 (0.1)	0.4	<.001	.81	NA	0.8	<.001	.24	NA	0.4	<.001	.11	NA
PE	5.7 (0.1)	6.2 (0.1)	6.3 (0.1)	0.4	<.001	NA	NA	0.5	<.001	NA	NA	0.1	.24	NA	NA
Time in bed, h (P < .001)^f
All participants	8.0 (0.1)	7.5 (0.1)	7.8 (0.1)	−0.5	<.001	NA	NA	−0.2	<.001	NA	NA	0.3	<.001	NA	NA
SHUTi-BWHS	8.2 (0.1)	7.3 (0.1)	7.5 (0.1)	−0.9	<.001	<.001	.22	−0.7	<.001	<.001	.01	0.2	.02	.51	.12
SHUTi	8.0 (0.1)	7.3 (0.1)	7.8 (0.1)	−0.7	<.001	<.001	NA	−0.3	.03	.002	NA	0.5	<.001	.03	NA
PE	7.9 (0.1)	8.0 (0.1)	8.2 (0.1)	0.1	.20	NA	NA	0.3	.01	NA	NA	0.1	.12	NA	NA
Sleep efficiency, % (P < .001) ^g
All participants	72.2 (0.7)	81.2 (0.6)	81.5 (0.6)	9.0	<.001	NA	NA	9.3	<.001	NA	NA	0.3	.51	NA	NA
SHUTi-BWHS	73.1 (1.1)	83.5 (1.0)	84.5 (1.1)	10.4	<.001	<.001	.27	11.4	<.001	<.001	.61	1.0	.26	.93	.93
SHUTi	70.9 (1.1)	83.1 (1.1)	83.1 (1.1)	12.2	<.001	<.001	NA	12.3	<.001	<.001	NA	0.0	.97	.98	NA
PE	72.7 (1.1)	77.0 (1.0)	77.0 (1.0)	4.3	<.001	NA	NA	4.3	<.001	NA	NA	0.0	.99	NA	NA
Pittsburgh Sleep Quality Index (P < .001)
All participants	12.7 (0.2)	9.2 (0.2)	8.7 (0.2)	−3.6	<.001	NA	NA	−4.0	<.001	NA	NA	−0.5	.02	NA	NA
SHUTi-BWHS	12.3 (0.3)	8.1 (0.3)	7.5 (0.4)	−4.2	<.001	<.001	.43	−4.8	<.001	<.001	.29	−0.6	.07	.86	.86
SHUTi	12.7 (0.3)	8 .0 (0.4)	7.5 (0.4)	−4.8	<.001	<.001	NA	−5.3	<.001	<.001	NA	−0.5	.16	.86	NA
PE	13.1 (0.3)	11.4 (0.3)	11.1 (0.4)	−1.7	<.001	NA	NA	−2.0	<.001	NA	NA	−0.3	.35	NA	NA

Open in a new tab

Abbreviations: BWHS, Black Women’s Health Study; NA, not applicable; PE, patient education; SHUTi, Sleep Healthy Using the Internet.

^{^a}

Means presented are least squares means from mixed-effects linear regression model.

^{^b}

Estimated within-group change from mixed-effects linear regression model.

^{^c}

P value for within-group change.

^{^d}

P value for change between indicated group and PE group from mixed-effects linear regression model with Hochberg correction for multiple comparisons.

^{^e}

P value for change between indicated group and SHUTi group from mixed-effects linear regression model with Hochberg correction for multiple comparisons.

^{^f}

P value for comparing the 3 study groups on change over time, from the group × time interaction in mixed-effects linear regression model.

^{^g}

Calculated as total time spent asleep divided by total time spent in bed, multiplied by 100.

There were no statistically significant differences in the change in ISI scores from time 1 to time 3 between the SHUTi-BWHS and SHUTi participants (Table 3). Among participants receiving SHUTi-BWHS, 52 of 110 (47.3%) had more than a 7-point decrease in ISI score (treatment responder), and 41 of 110 (37.3%) reported an ISI score of less than 8 points by time 3 (insomnia fully resolved). Among SHUTi participants, 50 of 108 (46.3%) had an ISI decrease of more than 7 points, and 41 of 108 (38.0%) had an ISI score of less than 8 points by Time 3. Few SHUTi-BWHS and SHUTi participants (5 of 110 [4.5%] and 6 of 108 [5.6%], respectively) increased in ISI score during the study period.

Table 3. Treatment Response and Insomnia Remission After Time 3 (6-Month Assessment).

Outcome	Treatment arm, No. (%)			P value^a
Outcome	SHUTi-BWHS (n = 110)	SHUTi (n = 108)	PE (n = 115)	P value^a
Treatment response (ISI score decreased by >7 points)	52 (47.3)	50 (46.3)	17 (14.8)	.89
Insomnia remitted (final ISI score <8)	41 (37.3)	41 (38.0)	7 (6.1)	.92

Open in a new tab

Abbreviations: BWHS, Black Women’s Health Study; ISI, Insomnia Severity Index; PE, patient education; SHUTi, Sleep Healthy Using the Internet.

^{^a}

P value of difference in proportions between SHUTi-BWHS and SHUTi treatment arms.

Intervention Engagement

Significantly more participants randomized to the SHUTi-BWHS program completed the full intervention compared with those randomized to the SHUTi program. The completion rate for all 6 sessions among SHUTi-BWHS participants was 78.2% (86 of 110) compared with 64.8% (70 of 108) among SHUTi participants (P < .001). Full completers of either program had significantly greater improvements in their insomnia symptoms and in other sleep parameters than noncompleters (Table 4). Differences between time 1 and time 3 among completers vs noncompleters were ISI score (10.4-point decrease vs 6.2-point decrease, respectively), sleep onset latency (20.6-minute decrease vs 10.0-minute decrease), wake after sleep onset (21.4-minute decrease vs 3.5-minute decrease) sleep efficiency (13.3% increase vs 3.3% increase), and sleep quality (measured by PSQI; 5.7-point decrease vs 1.8-point decrease). We note that full completers of either program did not differ from noncompleters with respect to baseline insomnia severity.

Table 4. Changes in Sleep Parameters From Time 1 to Time 3 Comparing Participants Who Fully Completed Treatment in Either Intervention vs Those Who Did Not Fully Complete Treatment.

Outcome	Treatment completion, mean (SD)^a		P value
Outcome	Yes	No	P value
Insomnia Severity Index	−10.39 (6.2)	−6.16 (6.0)	.002
Sleep onset latency, min	−20.56 (28.4)	−10.04 (36.7)	.10
Wake after sleep onset, min	−21.37 (33.8)	−3.54 (25.7)	.01
Total sleep time, h	0.56 (1.2)	0.28 (1.2)	.26
Time in bed, h	−0.60 (1.2)	0.02 (0.8)	.01
Sleep efficiency, %^b	13.31 (12.1)	3.27 (9.5)	<.001
Pittsburgh Sleep Quality Index	−5.66 (4.1)	−1.83 (4.2)	<.001

Open in a new tab

^{^a}

Treatment completion defined as completion of all 6 sessions of their assigned treatment by participants in Sleep Healthy Using the Internet or Sleep Healthy Using the Internet–Black Women’s Health Study.

^{^b}

Calculated as total time spent asleep divided by total time spent in bed, multiplied by 100.

Discussion

CBT-I is the criterion-standard treatment for insomnia disorder. As access to CBT-I is limited,²⁴ automated CBT-I programs have been developed. The advantage of providing evidence-based insomnia treatment at scale is limited by adherence challenges,⁵⁵ especially when patients are asked to make major behavioral changes, such as during CBT-I.⁵⁶ Exacerbating this limitation, racial and ethnic minority populations are consistently less likely to initiate, continue, or complete behavioral health treatments.⁵⁷ Little is known about why this is the case or what can been done to address this challenge, with some hypothesizing that it may be because psychosocial intervention content is typically developed for and tested primarily in non-Hispanic White men and women.^58,59 Thus, we evaluated whether tailoring an automated CBT-I intervention for Black women would better engage participants. We compared a standard version of an internet-delivered CBT-I program (SHUTi) with a stakeholder-informed version tailored specifically for Black women (SHUTi-BWHS), assessing both treatment efficacy and program engagement.

Our findings indicate that both the SHUTi and SHUTi-BWHS programs significantly improved sleep health outcomes compared with PE about sleep; the improvements did not differ significantly between the SHUTi and SHUTi-BWHS programs. Comparable efficacy of the programs is not surprising, as core CBT-I principles were identical in both interventions. Our results add to SHUTi’s considerable body of evidence. At 6 months postintervention, insomnia improvements among intervention recipients were dramatic. Almost 40% of SHUTi or SHUTi-BWHS recipients experienced insomnia remission, and close to 50% reported clinically significant insomnia symptom improvements. Further, intervention participants saw their sleep efficiency increase by 10% to 12% through the 6-month follow-up. These improvements are comparable with those seen in prior SHUTi trials with samples that were comprised predominantly of non–racial and ethnic minority individuals^26,27 and when CBT-I is delivered in-person.⁶⁰ To put this degree of sleep efficiency improvement in context, a 10% improvement in sleep efficiency for women with breast cancer who were poor sleepers was associated with a 32% increase in survival.⁶¹

While it is important to demonstrate that SHUTi can improve the sleep of Black women, the significant differences in terms of treatment engagement are noteworthy: more Black women fully completed the version of the intervention that was tailored specifically for them. Similar to prior SHUTi trials, there was a direct association between the participant’s level of intervention engagement and their improvement in sleep.³³ The differences observed in our trial were not merely statistically significant but clinically meaningful as well. These results showing that it is possible to adapt a proven intervention to significantly increase treatment engagement for a racial minority group are compelling. Improving participation with a treatment as challenging as CBT-I is no small feat as it requires people to overhaul their sleep patterns, behaviors, and thoughts. While there has been past research showing that culturally tailored mental health programming is associated with improved treatment outcomes,⁶² there have been limited efforts for patients with insomnia disorder.^63,64 At the community level, the scale of public health improvement that is possible with a 13% increase in treatment engagement is immense, especially in a racial group that faces multiple barriers to treatment.^65,66 As it appears that tailoring intervention content may be important to maximizing the impact of CBT-I, future research in how to successfully adapt this treatment approach in other racial and ethnic minority groups is needed.

Limitations

This study has limitations. While the study sample was comprised entirely of a racial minority group (Black women), they were of a higher socioeconomic background than US Black women as a whole. This can limit the generalizability of our findings to Black women for whom health disparities are most salient. On the other hand, the women lived in a wide range of settings across the country, encountering a variety of circumstances that might impair sleep.⁶⁷ Medical mistrust exists for many marginalized groups, which can lead to poorer management of health conditions.⁶⁸ This issue was not directly addressed in the present study and is deserving of future attention. Only women participated in our study. There are known sex differences, with women more likely to report insomnia to health care professionals, seek treatment, and implement intervention strategies.^69,70 The study group was comprised of middle-aged and older women, which may limit the generalizability of study findings to other age groups. However, prior literature has demonstrated the efficacy of the SHUTi program and CBT-I across the life span. Study recruitment and data collection occurred before and during the COVID-19 pandemic. We did not systematically study this potential confounder. However, data suggests that treatment outcomes are likely to be similar for the pre– and post–COVID-19 group.⁷¹ Next, while our study was powered to detect moderate to large differences on the ISI as expected between a SHUTi intervention vs PE, it was not powered to detect smaller differences between 2 SHUTi intervention versions. Thus, our finding that participants given SHUTi and SHUTi-BWHS did not differ on the ISI should be taken with some caution. Additionally, this trial was conducted within an established cohort with a long history of engagement with members of the research team. This may explain why intervention completion rates even for the standard version of SHUTi were higher than among Black men and women in a recent trial of another online CBT-I program.⁷² Importantly, this further underscores the importance of working to connect with the community that programs are designed to reach.

Conclusions

Black individuals in the US are among the most likely to experience disparities in access to health care and, ultimately, poor health outcomes. There is a critical need to develop and evaluate evidence-based interventions to address these persistent racial gaps. The lack of culturally adapted interventions to improve sleep health among racial and ethnic minority populations persists, and to our knowledge, this is the first CBT-I intervention adapted for Black women. Results from the present trial provide intriguing data to encourage further studies in the effort to address health disparities in the context of insomnia disorder.

Supplement 1.

Trial protocol.

Click here for additional data file.^{(264.8KB, pdf)}

Supplement 2.

eFigure. Participant changes in insomnia severity and sleep efficiency across study time points.

Click here for additional data file.^{(305.1KB, pdf)}

Supplement 3.

Data sharing statement.

Click here for additional data file.^{(15.1KB, pdf)}

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial protocol.

Click here for additional data file.^{(264.8KB, pdf)}

Supplement 2.

eFigure. Participant changes in insomnia severity and sleep efficiency across study time points.

Click here for additional data file.^{(305.1KB, pdf)}

Supplement 3.

Data sharing statement.

Click here for additional data file.^{(15.1KB, pdf)}

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PERMALINK

Effect of Culturally Tailored, Internet-Delivered Cognitive Behavioral Therapy for Insomnia in Black Women

Eric S Zhou, PhD

Lee M Ritterband, PhD

Traci N Bethea, PhD

Yvonne P Robles, MPH

Timothy C Heeren, PhD

Lynn Rosenberg, ScD

Key Points

Question

Findings

Meaning

Abstract

Importance

Objective

Design, Setting, and Participants

Interventions

Main Outcomes and Measures

Results

Conclusions and Relevance

Trial Registration

Introduction

Methods

Study Design

Participants

Figure. Study Enrollment Flow.

Study Interventions

Study Measures

Sleep-Related Outcomes

Covariates

Table 1. Characteristics of Women Randomized in the Triala.

Statistical Analysis

Results

Changes to Sleep During the Study Period

Table 2. Changes in Sleep Parameters Over Time.

Table 3. Treatment Response and Insomnia Remission After Time 3 (6-Month Assessment).

Intervention Engagement

Table 4. Changes in Sleep Parameters From Time 1 to Time 3 Comparing Participants Who Fully Completed Treatment in Either Intervention vs Those Who Did Not Fully Complete Treatment.

Discussion

Limitations

Conclusions

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

Similar articles

Cited by other articles

Links to NCBI Databases

Table 1. Characteristics of Women Randomized in the Trial^a.