Reducing Health Disparities for Black Women in the Treatment of Insomnia

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03613519

Enrollment

333

Registered

2018-08-03

Start date

2019-10-08

Completion date

2021-03-09

Last updated

2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Patient education, Sleep hygiene, Sleep Healthy Using the Internet (SHUTi), Cognitive-behavioral therapy (CBT), Black Women's Health Study

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.

Interventions

BEHAVIORALSHUTi

A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.

BEHAVIORALmodified SHUTi (i.e., SHUTi-BWHS)

A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.

BEHAVIORALPatient education

A woman assigned to patient education receives access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participants do not know the treatment at the time of randomization.

Intervention model description

Eligible subjects will be randomly assigned to one of the 3 intervention groups; SHUTi-BWHS, SHUTi, or patient education (PE).

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Sleep Difficulties Assessed by the Insomnia Severity Index	Time 1 (baseline), Time 3 (6 months after expected completion of program)	A change in sleep difficulties will be assessed by the change in the ISI (Insomnia Severity Index) score. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by sleep difficulties. A 5-point Likert scale (0 = none; 4 = very severe) is used to rate each item, with total scores ranging from 0 to 28. A higher total score indicates more severe sleep difficulties.

Secondary

Measure	Time frame	Description
Change in Sleep Onset Latency (SOL)	Time 1 (baseline), Time 3 (6 months after expected completion of program)	SOL is the amount of time it takes to fall asleep measured in minutes.
Change in Wake After Sleep Onset (WASO)	Time 1 (baseline), Time 3 (6 months after expected completion of program)	WASO measures time awake after falling asleep measured in minutes.
Change in Total Sleep Time (TST)	Time 1 (baseline), Time 3 (6 months after expected completion of program)	TST is the amount of time spent asleep in bed, measured in minutes and then converted to hours. Total sleep time is calculated by subtracting SOL (Sleep Onset Latency, WASO (Wake After Sleep Onset) and EMA (Early Morning Arise) from total time in bed (TIB).
Change in Sleep Efficiency (SE)	Time 1 (baseline), Time 3 (6 months after expected completion of program)	Change in Sleep Efficiency (SE). SE is the change in the percentage of time spent asleep while in bed. SE is calculated by dividing the amount of time spent asleep (in minutes) by the total amount of time in bed (in minutes) times 100.
Completion of All 6 Cores/Modules	Time 3 (6 months after expected completion of program)	The percentage of participants in the SHUTi and modified SHUTI arms who completed all six cores/modules during the study

Countries

United States

Participant flow

Pre-assignment details

1010 completed the eligibility questionnaire. 490 were excluded for not meeting criteria and 187 declined to participate. The remaining 333 were randomized into one of the three trial arms.

Participants by arm

Arm	Count
Patient Education (Sleep Hygiene, Usual Care) A web-based program that presents ways to improve behaviors and environments that can affect sleep. Patient Education: A woman assigned to Patient Education receive access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.	115
SHUTi (Sleep Healthy Using the Internet) SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I) SHUTi: A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of about 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.	108
Modified SHUTi (SHUTi Modified for Black Women) The CBT-I instrument tailored for Black women. Modified SHUTi (i.e., SHUTi-BWHS): A woman assigned to modified SHUTi (i.e., to SHUTi-BWHS) receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.	110
Total	333

Baseline characteristics

Characteristic	Patient Education (Sleep Hygiene, Usual Care)	SHUTi (Sleep Healthy Using the Internet)	Modified SHUTi (SHUTi Modified for Black Women)	Total
Age, Continuous	59.2 years STANDARD_DEVIATION 7.7	59.9 years STANDARD_DEVIATION 8	59.6 years STANDARD_DEVIATION 8.4	59.5 years STANDARD_DEVIATION 8
Body Mass Index (BMI= kg/m^2) <25	16 percent of participants	23 percent of participants	30 percent of participants	23 percent of participants
Body Mass Index (BMI= kg/m^2) 25-29	27 percent of participants	26 percent of participants	23 percent of participants	25 percent of participants
Body Mass Index (BMI= kg/m^2) 30 or greater	51 percent of participants	47 percent of participants	40 percent of participants	46 percent of participants
Body Mass Index (BMI= kg/m^2) Unknown	6 percent of participants	4 percent of participants	7 percent of participants	6 percent of participants
Insomnia Severity Index	19.2 score on a scale STANDARD_DEVIATION 0.3	18.3 score on a scale STANDARD_DEVIATION 0.4	18.7 score on a scale STANDARD_DEVIATION 0.4	18.8 score on a scale STANDARD_DEVIATION 0.2
Race/Ethnicity, Customized Black/African American	115 Participants	108 Participants	110 Participants	333 Participants
Region of Enrollment United States	115 participants	108 participants	110 participants	333 participants
Sex: Female, Male Female	115 Participants	108 Participants	110 Participants	333 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants	0 Participants
Sleep Efficiency	72.7 percent STANDARD_DEVIATION 1.1	70.9 percent STANDARD_DEVIATION 1.1	73.1 percent STANDARD_DEVIATION 1.1	72.2 percent STANDARD_DEVIATION 0.7
Sleep Onset Latency	41.6 minutes STANDARD_DEVIATION 2.6	47.5 minutes STANDARD_DEVIATION 2.7	38.0 minutes STANDARD_DEVIATION 2.7	42.3 minutes STANDARD_DEVIATION 1.6
Smoking history Current	4 percent of participants	9 percent of participants	5 percent of participants	6 percent of participants
Smoking history Never	71 percent of participants	74 percent of participants	66 percent of participants	71 percent of participants
Smoking history Past	24 percent of participants	17 percent of participants	29 percent of participants	23 percent of participants
Total Sleep Time	5.7 hours STANDARD_DEVIATION 0.1	5.7 hours STANDARD_DEVIATION 0.1	6.0 hours STANDARD_DEVIATION 0.1	5.8 hours STANDARD_DEVIATION 0.1
Weekly alcohol consumption	1.2 drinks per week STANDARD_DEVIATION 2.1	1.8 drinks per week STANDARD_DEVIATION 2.6	1.1 drinks per week STANDARD_DEVIATION 1.9	1.4 drinks per week STANDARD_DEVIATION 2.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 115	0 / 108	0 / 110
other Total, other adverse events	0 / 115	0 / 108	0 / 110
serious Total, serious adverse events	0 / 115	0 / 108	0 / 110

Outcome results

Primary

Change in Sleep Difficulties Assessed by the Insomnia Severity Index

A change in sleep difficulties will be assessed by the change in the ISI (Insomnia Severity Index) score. The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the past month. The specific items evaluate the severity of difficulties with sleep onset, sleep maintenance, and early morning awakening; sleep dissatisfaction; interference of sleep problems with daytime functioning; noticeability of sleep difficulties by others; and distress caused by sleep difficulties. A 5-point Likert scale (0 = none; 4 = very severe) is used to rate each item, with total scores ranging from 0 to 28. A higher total score indicates more severe sleep difficulties.