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

Primary Purpose

Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tele-Brief Behavioral Treatment for Insomnia
Tele-Cognitive-Behavioral Therapy for Insomnia
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet clinical diagnostic criteria for insomnia Insomnia severity score > 11 Eligible to receive care through publicly supported medical assistance, OR Identify as race or ethnic minority, OR Spanish speaking Exclusion Criteria: Untreated, current major depressive disorder History of bipolar or psychosis Active substance abuse 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tele-Brief Behavioral Treatment for Insomnia

    Tele-Cognitive-Behavioral Therapy for Insomnia

    Arm Description

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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).
    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.
    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.
    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.
    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.
    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.
    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.
    Diary reported sleep duration
    Self-reported sleep duration with be measured using sleep diary
    Diary-reported sleep efficiency
    Self-reported sleep efficiency with be measured using sleep diary
    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

    Full Information

    First Posted
    February 8, 2023
    Last Updated
    March 10, 2023
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05759065
    Brief Title
    A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
    Official Title
    A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2027 (Anticipated)
    Study Completion Date
    June 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tele-Brief Behavioral Treatment for Insomnia
    Arm Type
    Experimental
    Arm Title
    Tele-Cognitive-Behavioral Therapy for Insomnia
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tele-Brief Behavioral Treatment for Insomnia
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tele-Cognitive-Behavioral Therapy for Insomnia
    Intervention Description
    Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
    Primary Outcome Measure Information:
    Title
    Insomnia severity index, ISI
    Description
    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).
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Insomnia severity index, ISI
    Description
    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).
    Time Frame
    6- and 12-months
    Title
    Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
    Description
    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.
    Time Frame
    3-months
    Title
    Quality of Life and Symptoms - Generic-quality of life
    Description
    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.
    Time Frame
    3-months
    Title
    Generalized Anxiety Disorder (GAD-7)
    Description
    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.
    Time Frame
    3-months
    Title
    Patient Health Questionnaire for depression (PHQ-8)
    Description
    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.
    Time Frame
    3-months
    Title
    Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a
    Description
    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.
    Time Frame
    3-months
    Title
    Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
    Description
    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.
    Time Frame
    3-months
    Title
    Diary reported sleep duration
    Description
    Self-reported sleep duration with be measured using sleep diary
    Time Frame
    3-months
    Title
    Diary-reported sleep efficiency
    Description
    Self-reported sleep efficiency with be measured using sleep diary
    Time Frame
    3-months
    Title
    Number of participants with hypnotic use self-reported from the sleep diary
    Description
    Hypnotic use will be measured by the number of participants who self-reported use on the sleep diary
    Time Frame
    3-months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet clinical diagnostic criteria for insomnia Insomnia severity score > 11 Eligible to receive care through publicly supported medical assistance, OR Identify as race or ethnic minority, OR Spanish speaking Exclusion Criteria: Untreated, current major depressive disorder History of bipolar or psychosis Active substance abuse 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suzanne Bertisch, MD, MPH
    Phone
    857-307-0355
    Email
    sbertisch@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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