A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Soc… (NCT05759065) | Clinical Trial Compass
RecruitingNot Applicable
A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
United States350 participantsStarted 2024-04-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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