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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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.
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGInsomnia 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).
Time frame: 3 months
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).
Time frame: 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.
Time frame: 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.
Time frame: 3-months
Generalized Anxiety Disorder (GAD-7)
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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
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-months
Diary reported sleep duration
Self-reported sleep duration with be measured using sleep diary
Time frame: 3-months
Diary-reported sleep efficiency
Self-reported sleep efficiency with be measured using sleep diary
Time frame: 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
Time frame: 3-months