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

Study Overview
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Brief Summary
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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.

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

Conditions
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Insomnia

Intervention / Treatment
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* Behavioral: Tele-Brief Behavioral Treatment for Insomnia
* Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-Brief Behavioral Treatment for Insomnia<br> | Behavioral: Tele-Brief Behavioral Treatment for Insomnia<br>* 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.<br>|
| Active Comparator: Tele-Cognitive-Behavioral Therapy for Insomnia<br> | Behavioral: Tele-Cognitive-Behavioral Therapy for Insomnia<br>* Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.<br>|

What is the study measuring?
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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 |