InsomniaNCT03613519
Reducing Health Disparities for Black Women in the Treatment of Insomnia
A study testing SHUTi, modified SHUTi (i.e., SHUTi-BWHS) and Patient education in people with Insomnia, run by Boston University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- SHUTi, modified SHUTi (i.e., SHUTi-BWHS) and Patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 9 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants in the Black Women's Health Study (BWHS) with clinically elevated symptoms of insomnia previously reported on a BWHS questionnaire.
- Access to a computer or tablet and internet access
Who cannot join
- Intention to change use pattern of prescribed or over-the-counter sleep aid
- 1 or more untreated sleep disorders
- Employed in a position where sleep restriction may endanger others
- Active shift work employment
- Untreated, current, and/or severe psychiatric condition
- Consume 14 or more alcoholic drinks/week
- Unstable or acute medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Slone Epidemiology Center at Boston University
Boston, Massachusetts, 02118
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- SHUTi, modified SHUTi (i.e., SHUTi-BWHS), Patient education
- Keywords
- Patient education, Sleep hygiene, Sleep Healthy Using the Internet (SHUTi), Cognitive-behavioral therapy (CBT), Black Women's Health Study
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHUTiBehavioural
Also called web-based cognitive-behavioral therapy for insomnia (CBT-I)
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.
modified SHUTi (i.e., SHUTi-BWHS)Behavioural
Also called web-based CBT-I tailored for Black women
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.
Patient educationBehavioural
Also called sleep hygiene
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 group | Role | What they receive |
|---|---|---|
| Patient education (sleep hygiene) | Placebo comparator | A web-based program that presents ways to improve behaviors and environments that can affect sleep. Receives: Behavioral: Patient education |
| SHUTi (Sleep Healthy Using the Internet) | Active comparator | SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I) Receives: Behavioral: SHUTi |
| modified SHUTi (SHUTi modified for Black women) | Active comparator | The CBT-I instrument tailored for Black women. Receives: Behavioral: modified SHUTi (i.e., SHUTi-BWHS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Secondary outcomes (5)
Change in Sleep Onset Latency (SOL)
SOL is the amount of time it takes to fall asleep measured in minutes.
Measured: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Wake After Sleep Onset (WASO)
WASO measures time awake after falling asleep measured in minutes.
Measured: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Total Sleep Time (TST)
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).
Measured: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Sleep Efficiency (SE)
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.
Measured: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Completion of All 6 Cores/Modules
The percentage of participants in the SHUTi and modified SHUTI arms who completed all six cores/modules during the study
Measured: Time 3 (6 months after expected completion of program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start8 Oct 2019
- Primary completion9 Mar 2021
- Study completion9 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible subjects will be randomly assigned to one of the 3 intervention groups; SHUTi-BWHS, SHUTi, or patient education (PE).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Lynn Rosenberg, ScD, Principal investigator, Senior Epidemiologist, Professor of EpidemiologyEric S Zhou, PhD, Principal investigator, Division of Sleep Medicine, Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613519
- Sponsor's protocol ID
- H-37156
- Other IDs
- AD-2017C1-6314
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2018
- Last updated
- 25 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35442432
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Health Disparities for Black Women in the Treatment of Insomnia
- ClinicalTrials.gov ID
- NCT03613519
- Acronym / sponsor ID
- H-37156
- Conditions
- Insomnia
- Keywords
- Patient education, Sleep hygiene, Sleep Healthy Using the Internet (SHUTi), Cognitive-behavioral therapy (CBT), Black Women's Health Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Mar 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 25 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Eligible subjects will be randomly assigned to one of the 3 intervention groups; SHUTi-BWHS, SHUTi, or patient education (PE).
| Arm | Type | Receives |
|---|---|---|
| Patient education (sleep hygiene) | Placebo comparator | Behavioral: Patient educationA web-based program that presents ways to improve behaviors and environments that can affect sleep. |
| SHUTi (Sleep Healthy Using the Internet) | Active comparator | Behavioral: SHUTiSHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I) |
| modified SHUTi (SHUTi modified for Black women) | Active comparator | Behavioral: modified SHUTi (i.e., SHUTi-BWHS)The CBT-I instrument tailored for Black women. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants in the Black Women's Health Study (BWHS) with clinically elevated symptoms of insomnia previously reported on a BWHS questionnaire.
- Access to a computer or tablet and internet access
Key exclusion criteria (7 listed)
- Intention to change use pattern of prescribed or over-the-counter sleep aid
- 1 or more untreated sleep disorders
- Employed in a position where sleep restriction may endanger others
- Active shift work employment
- Untreated, current, and/or severe psychiatric condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHUTiAlso: web-based cognitive-behavioral therapy for insomnia (CBT-I)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. | Behavioural | SHUTi (Sleep Healthy Using the Internet) |
| modified SHUTi (i.e., SHUTi-BWHS)Also: web-based CBT-I tailored for Black womenA 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. | Behavioural | modified SHUTi (SHUTi modified for Black women) |
| Patient educationAlso: sleep hygieneA 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. | Behavioural | Patient education (sleep hygiene) |
Primary outcome
Change in Sleep Difficulties Assessed by the Insomnia Severity Index
Time frame: 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.
5 secondary outcomes
Change in Sleep Onset Latency (SOL)
Time frame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Wake After Sleep Onset (WASO)
Time frame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Total Sleep Time (TST)
Time frame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Change in Sleep Efficiency (SE)
Time frame: Time 1 (baseline), Time 3 (6 months after expected completion of program)
Completion of All 6 Cores/Modules
Time frame: Time 3 (6 months after expected completion of program)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35442432Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Rosenberg, ScD principal investigator
Senior Epidemiologist, Professor of Epidemiology
Eric S Zhou, PhD principal investigator
Division of Sleep Medicine, Harvard Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHUTi, modified SHUTi (i.e., SHUTi-BWHS) and Patient education in people with Insomnia, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sleep Difficulties Assessed by the Insomnia Severity Index (time frame: Time 1 (baseline), Time 3 (6 months after expected completion of program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03613519, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.