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Hospital-Level psychiatric care comes home in new pilot study

NCT ID NCT07364825

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This pilot study is testing whether adults with serious mental health issues like psychosis, anxiety, or depression can receive hospital-level care in their own homes. Researchers will see how many people are eligible and willing to try this approach. The goal is to offer a safe, comfortable alternative to traditional hospital stays.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Behavioral Health Home Hospital (home-based psychiatric care)
What this could lead to
If successful, this could offer a safe, comfortable alternative to hospital stays for people with acute mental health conditions.
What could go wrong
This is a very small pilot study (41 people) and only looks at eligibility and retention, not whether home care is as effective as hospital care. It may not work for everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

41 people

The number who actually took part.

Started

Jan 2026

Finished

May 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

General patient inclusion criteria: ≥18 years old Resides or will reside during hospital care within a 10-mile geographic area surrounding BWFH or BWH. Patients must be able to be safely managed at home with the in-home clinical coverage and monitoring provided by the BHH program, as determined by the BHH MD. If the BHH MD determines that caregiver support is required for safe participation, the patient must have a caregiver who is able to provide the required level of support to be eligible for enrollment. The level of caregiver support will be determined on a case-by-case basis by the patient's clinical team and BHH MD based on the patient's clinical presentation, safety needs, and functional status (see section 6.1 for details) To participate in the study, the patient must agree to the level of in-home support and monitoring determined by the study doctor and clinical team. This could include the possibility of asking the patient to agree to be in the same home with their caregiver 24/7 during their entire hospitalization. Patient clinical inclusion criteria Voluntarily consent to BHH admission (patient or proxy consent; if proxy consents, patient assents) Requires hospital-level care for anxiety/depression, psychosis, or behavioral and psychological symptoms of dementia (BPSD) No current restraint use No catatonia Has capacity to consent OR can assent to study and has proxy who can consent Does not need in person socialization that cannot be provided remotely Can reliably communicate with the BHH team (self or caregiver) Does not need safety monitoring more frequently than every 30 minutes Medical condition(s) manageable by BHH Is not a risk of harm to others, and meets the following criteria: Has not harmed staff in the past Consider excluding for a score \>1 on the Broset Violence Checklist Consider prior harm to others; determine context surrounding prior harm, consider other collateral information from family, friends, and other providers Is not a risk of harm to self, and meets the following criteria: SAFE-T Protocol with a Columbia-Suicide Severity Rating Scale (C-SSRS) that is low or moderate risk No evidence of alcohol intoxication or risk of severe withdrawal No active substance use or if substance use then they can abstain during hospitalization (Consider any active treatment plan, type of substance used, and access to substances) Consider previous suicide attempts, intensity, lethality, and compulsivity of self-harm behaviors when determining eligibility Patient does not have behaviors that would prevent them from being cared for at home: Modified Agitation Severity Scale (MASS) score \< 6 Does not have lack of insight or severe disorganization Pittsburgh Agitation Scale score \< 3. Consider excluding the patient for a score of 3 or 4. Patient diagnosis-specific inclusion criteria: If patient has a diagnosis of psychosis: They have NOT developed ideas/beliefs which are significantly detached from the shared beliefs of others If patient has a diagnosis of BPSD, patient must: Have an identifiable treatment goal Be willing and able to participate in therapeutic care Agree to wear the Angelsense device Patient environmental inclusion criteria: HITS Screening Tool for Domestic Violence (requires patient interview) negative Is not in police custody Is not undomiciled Does not reside in a skilled nursing facility, long term acute care hospital, or detoxification facility Residence has the capacity to be therapeutic and has working heat (Oct-Apr), working air conditioner if forecast \>80 F (Jun-Sep), running water, electricity, and no suspected bed bugs, lice, or scabies No direct access to a firearm (even if stored) No illicit drugs in the home Willing and able to secure pets during BHH visits Willing to secure medications and other substances, including marijuana, in a BHH lockbox during BHH Has access to their home (e.g., keys to get into their house) Caregiver inclusion criteria (caregiver is not required to participate in the study; if a caregiver does enroll in the study, the following inclusion criteria apply) Age \>= 18 years old Has capacity to consent to study Clinician inclusion criteria A BHH clinical team member (a clinician providing care in the home, in-person or remotely). Or a clinician at the hospital providing care to a control patient

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Brigham and Women's Faulkner Hospital

    Jamaica Plain, Massachusetts, 02130, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.