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New program aims to prevent emotional distress after brain injury

NCT ID NCT05157880

Knowledge-focused Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a short, 6-session program for patients with a recent brain injury and their caregivers. The goal is to prevent long-term emotional distress and improve quality of life. About 388 pairs (patient and caregiver) will take part.

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

About 388 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

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.

Inclusion Criteria: * Age 18 or older * English fluency and literacy * Patient with an informal caregiver available and willing to participate * Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI * Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores \> 7) Exclusion Criteria: * Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible * Short form of Mini-Mental State Exam (SMMSE) score \<4 (If SMMSE \<4, nursing team decides whether or not the patient can meaningfully participate) * Glasgow Coma Scale (GCS) score \<10 * Terminal diagnosis * Lack of access to internet and/or a device with a camera * Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

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Conditions

The condition(s) this trial relates to.

brain injury nervous system injury

As listed by the trial registrant

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

Acute neurological injury Emotional distress

Contacts and locations

Locations

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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