A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
- Conditions
- Insomnia
- Interventions
- Behavioral: Tele-Cognitive-Behavioral Therapy for InsomniaBehavioral: Tele-Brief Behavioral Treatment for Insomnia
- Registration Number
- NCT05759065
- Lead Sponsor
- Brigham and Women's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
- Pregnant or planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-Cognitive-Behavioral Therapy for Insomnia Tele-Cognitive-Behavioral Therapy for Insomnia - Tele-Brief Behavioral Treatment for Insomnia Tele-Brief Behavioral Treatment for Insomnia -
- Primary Outcome Measures
Name Time Method Insomnia severity index, ISI 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 Outcome Measures
Name Time Method Quality of Life and Symptoms - Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 3-months 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.
Patient Health Questionnaire for depression (PHQ-8) 3-months 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 3-months 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.
Insomnia severity index, ISI 6- and 12-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).
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b 3-months 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 efficiency 3-months Self-reported sleep efficiency with be measured using sleep diary
Quality of Life and Symptoms - Generic-quality of life 3-months 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) 3-months 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.
Diary reported sleep duration 3-months Self-reported sleep duration with be measured using sleep diary
Number of participants with hypnotic use self-reported from the sleep diary 3-months Hypnotic use will be measured by the number of participants who self-reported use on the sleep diary
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States