A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care

The overall objective of this study is to conduct a randomized effectiveness-implementation trial to test the non-inferiority of tele-Brief Behavioral Treatment for Insomnia vs. tele-Cognitive-Behavioral Therapy for Insomnia among socioeconomically disadvantaged adults with insomnia in the primary care setting.

Study Overview

• Status: Recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: Tele-Brief Behavioral Treatment for Insomnia; Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suzanne Bertisch, MD, MPH; Phone Number: 857-307-0355; Email: sbertisch@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Carolina Dos Santos; Phone Number: 617-278-0746

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older
• Meet clinical diagnostic criteria for insomnia
• Insomnia severity score > 10
• Eligible to receive care through publicly supported medical assistance, OR
• Identify as race or ethnic minority
• Has capacity for informed consent

Exclusion Criteria:

• Untreated, current major depressive disorder
• History of bipolar or psychosis
• Active substance abuse or drug abuse
• Excessive daytime sleepiness
• Seizure within the past 1 year
• Main sleep period outside of 8pm - 11am
• Regular nightshift work
• Untreated, previously diagnosed moderate to severe sleep apnea
• Severe medical condition, which may require hospitalizations over the next 6 months
• Active suicidal ideation, if elicited passively during screening
• Pregnant or planning to become pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-Brief Behavioral Treatment for Insomnia	Behavioral: Tele-Brief Behavioral Treatment for Insomnia; Brief Behavioral Treatment for Insomnia (BBTI) comprises of up to five weekly intervention visits by phone, delivered by a variety of practitioners without formal training in sleep.
Active Comparator: Tele-Cognitive-Behavioral Therapy for Insomnia	Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia; Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity index, ISI	The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia severity index, ISI	The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).	6- and 12-months
Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health	The PROMIS Global Health measures assess an individual's physical, mental and social health. The measure produces two scores: Physical and Mental Health from 4 items each. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.	3-months
Quality of Life and Symptoms - Generic-quality of life	Generic-quality of life will be assessed by the change in the Euroqol - 5 Dimensions (EQ-5D) questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. There is no total score or range.	3-months
Generalized Anxiety Disorder (GAD-7)	GAD-7 measures self-reported anxiety disorder. The measure includes 7-items with higher scores indicating anxiety. The minimum score is 0 and the maximum score is 21.	3-months
Patient Health Questionnaire for depression (PHQ-8)	PHQ-8 measures self-reported current depression. The measure includes 8-items with higher scores indicating depression. The minimum score is 0 and the maximum score is 24.	3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a	PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.	3-months
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b	PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.	3-months
Diary reported sleep duration	Self-reported sleep duration with be measured using sleep diary	3-months
Diary-reported sleep efficiency	Self-reported sleep efficiency with be measured using sleep diary	3-months
Number of participants with hypnotic use self-reported from the sleep diary	Hypnotic use will be measured by the number of participants who self-reported use on the sleep diary	3-months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 8, 2023
• First Submitted That Met QC Criteria: February 25, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2023P000106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No