Reducing Health Disparities for Black Women in the Treatment of Insomnia

NCT03613519 | Completed Results

• 2 other identifiers: H-37156AD-2017C1-6314
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Time 1 (baseline), Time 3 (6 months after expected completion of program)

Secondary Outcomes (5)

• Change in Sleep Onset Latency (SOL)

  Time 1 (baseline), Time 3 (6 months after expected completion of program)

• Change in Wake After Sleep Onset (WASO)

  Time 1 (baseline), Time 3 (6 months after expected completion of program)

• Change in Total Sleep Time (TST)

  Time 1 (baseline), Time 3 (6 months after expected completion of program)

• Change in Sleep Efficiency (SE)

  Time 1 (baseline), Time 3 (6 months after expected completion of program)

• Completion of All 6 Cores/Modules

  Time 3 (6 months after expected completion of program)

Study Arms (3)

Patient education (sleep hygiene)

PLACEBO COMPARATOR

A web-based program that presents ways to improve behaviors and environments that can affect sleep.

Behavioral: Patient education

SHUTi (Sleep Healthy Using the Internet)

ACTIVE COMPARATOR

SHUTi is web-based cognitive-behavioral therapy instrument for insomnia (CBT-I)

Behavioral: SHUTi

modified SHUTi (SHUTi modified for Black women)

ACTIVE COMPARATOR

The CBT-I instrument tailored for Black women.

Behavioral: modified SHUTi (i.e., SHUTi-BWHS)

Interventions

SHUTi BEHAVIORAL

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.

Also known as: web-based cognitive-behavioral therapy for insomnia (CBT-I)

SHUTi (Sleep Healthy Using the Internet)

modified SHUTi (i.e., SHUTi-BWHS) BEHAVIORAL

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.

Also known as: web-based CBT-I tailored for Black women

modified SHUTi (SHUTi modified for Black women)

Patient education BEHAVIORAL

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.

Also known as: sleep hygiene

Patient education (sleep hygiene)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Gender Eligibility Details: Participants in the Black Women's Health Study who have reported symptoms of insomnia on the 2015 BWHS follow-up questionnaire
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intention to change use pattern of prescribed or over-the-counter sleep aid
• 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

Sponsors & Collaborators

• Boston University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Slone Epidemiology Center at Boston University

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

• 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.

  PMID: 35442432 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Hygiene

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

The study sample, comprised entirely of Black women who have not previously been studied, are of a higher socioeconomic background than US Black women as a whole. However, participants lived in a wide range of settings across the country, encountering a variety of circumstances that might impair sleep.

Results Point of Contact

• Title: Lynn Rosenberg, ScD
• Organization: Boston University School of Public Health

lrosenbe@bu.edu

617.734.6006

Study Officials

• Lynn Rosenberg, ScD

  Senior Epidemiologist, Professor of Epidemiology

  PRINCIPAL INVESTIGATOR

• Eric S Zhou, PhD

  Division of Sleep Medicine, Harvard Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know the treatment at the time of randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 3, 2018
• Study Start: October 8, 2019
• Primary Completion: March 9, 2021
• Study Completion: March 9, 2021
• Last Updated: October 25, 2022
• Results First Posted: October 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)