Intervention for patients with acute brain injury and their caregivers
Recovering Together: Building Resiliency in Dyads of Patients With an Acute Brain Injury Admitted to the Neuroscience Intensive Care Unit and Their Informal Caregivers
This study tests a six-session program called Recovering Together to see if it can help patients with acute brain injuries and their caregivers feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 388 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05157880 on ClinicalTrials.gov |
What this trial studies
This investigation aims to evaluate the effectiveness of a brief six-session intervention designed for patients with acute neurological injuries and their informal caregivers. The program, called Recovering Together, focuses on reducing chronic emotional distress and improving overall quality of life for both patients and caregivers. Participants will be randomly assigned to either the active intervention or an educational control group, with assessments conducted at baseline, after the program, and three months later. The study will take place at the Massachusetts General Hospital Neuro-ICU, utilizing a single-blinded design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older who are hospitalized with an acute neurological injury and have a willing informal caregiver.
Not a fit: Patients with severe cognitive impairments or terminal diagnoses may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce emotional distress and improve recovery outcomes for patients and their caregivers.
How similar studies have performed: Previous studies have shown promise in similar dyadic interventions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Ana-Maria Vranceanu, PhD
- Email: avranceanu@mgh.harvard.edu
- Phone: 617-724-4977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.