A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Insomnia severity index, ISI
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 years or older
- •Meet clinical diagnostic criteria for insomnia (DSM-V criteria)
- •Insomnia severity score > 10
- •Eligible to receive care through publicly-supported medical assistance (e.g. Commonwealth Connector plan; MassHealth. For participants >65 years old on Medicare, they will be asked about insurance coverage prior to initiating Medicare, OR
- •Identify as racial or ethnic minority
- •Has capacity for informed consent (SDT<9)
Exclusion Criteria
- •Untreated, current major depressive disorder (PHQ-8≥ 20)
- •History of bipolar disorder or psychosis
- •Active alcohol abuse (Alcohol Use Disorders Identification Test, AUDIT-C) or drug abuse (Drug Abuse Screening Test, DAST-2 ≥1)
- •Excessive daytime sleepiness (Epworth Sleepiness Scale score ≥ 16)
- •Seizure within the past 1 year
- •Main sleep period outside of 8pm - 11am
- •Regular nightshift work (5 overnight shifts/month, defined as working between midnight-5am)
- •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 (self-reported)
- •Participation in other studies that may impact the benefit or safety of the intervention, as determined by the study PI
Arms & Interventions
Tele-Brief Behavioral Treatment for Insomnia
Intervention: Tele-Brief Behavioral Treatment for Insomnia (Behavioral)
Tele-Cognitive-Behavioral Therapy for Insomnia
Intervention: Tele-Cognitive-Behavioral Therapy for Insomnia (Behavioral)
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
- Diary reported sleep duration(3-months)
- Quality of Life and Symptoms - Generic-quality of life(3-months)
- Generalized Anxiety Disorder (GAD-7)(3-months)
- Number of participants with hypnotic use self-reported from the sleep diary(3-months)
- 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)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b(3-months)
- Diary-reported sleep efficiency(3-months)
- Insomnia severity index, ISI(6- and 12-months)
Investigators
Suzanne M. Bertisch, MD, MPH
Associate Physician, Clinical Director of Behavioral Sleep Medicine
Brigham and Women's Hospital