Trial studying safety and effects for Insomnia
Official title A Hybrid Effectiveness Implementation Trial Evaluating Behavioral Treatments for Insomnia for Socioeconomically Disadvantaged Adults in Primary Care
ClinicalTrials.gov ID: NCT05759065
What this study is testing
- What it's testing
- The study will find out whether a brief tele‑behavioral treatment works at least as well as standard tele‑cognitive‑behavioral therapy for insomnia in socioeconomically disadvantaged adults.
- Who it's for
- Adults with insomnia who are socioeconomically disadvantaged and receive primary‑care services.
- What's involved
- Participants will be randomly assigned to receive either a brief behavioral insomnia program or a full cognitive‑behavioral therapy program, both delivered by video or phone, with follow‑up visits and questionnaires.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Identify as racial or ethnic minority
You likely can't join if
- 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
See the full eligibility 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.
- Identify as racial or ethnic minority
- Has capacity for informed consent (SDT\<9)
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.