A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Insomnia severity index, ISI
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Suzanne M. Bertisch, MD, MPH
Associate Physician, Clinical Director of Behavioral Sleep Medicine
Brigham and Women's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Insomnia severity index, ISI
Time Frame: 3 months
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 Outcomes
- Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health(3-months)
- Patient Health Questionnaire for depression (PHQ-8)(3-months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Impairment, 8a(3-months)
- Insomnia severity index, ISI(6- and 12-months)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b(3-months)
- Diary-reported sleep efficiency(3-months)
- Quality of Life and Symptoms - Generic-quality of life(3-months)
- Generalized Anxiety Disorder (GAD-7)(3-months)
- Diary reported sleep duration(3-months)
- Number of participants with hypnotic use self-reported from the sleep diary(3-months)