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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759065
• Other study ID #: 2023P000106
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Suzanne Bertisch, MD, MPH
• Phone: 857-307-0355
• Email: sbertisch[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Pregnant or planning to become pregnant

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Tele-Brief Behavioral Treatment for Insomnia
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.
• Tele-Cognitive-Behavioral Therapy for Insomnia
Cognitive-Behavioral Therapy for Insomnia (CBTI) is a multicomponent strategy delivered by trained mental health clinicians over 6 to 12 weeks.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Diary reported sleep duration	Self-reported sleep duration with be measured using sleep diary	3-months
Secondary	Diary-reported sleep efficiency	Self-reported sleep efficiency with be measured using sleep diary	3-months
Secondary	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