Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers

Last updated: October 18, 2025
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Recovering Together

Clinical Study ID

NCT05157880
2021P001943
  • Ages > 18
  • All Genders

Study Summary

The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.

Eligibility Criteria

Inclusion

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 apatient currently admitted with any ANI

  • Patient and/or caregiver exhibit emotional distress on screening (using HADS Dand/or HADS A scores > 7)

Exclusion

Exclusion Criteria:

  • Permanent cognitive impairment (including severe hearing impairment) or aphasia thatmakes participation impossible

  • Short form of Mini-Mental State Exam (SMMSE) score <4 (If SMMSE <4, nursing teamdecides 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

Study Design

Total Participants: 388
Treatment Group(s): 1
Primary Treatment: Recovering Together
Phase:
Study Start date:
December 10, 2021
Estimated Completion Date:
March 31, 2026

Study Description

The goals of this study are to: 1) demonstrate the efficacy of Recovering Together for improving self-reported emotional distress (primary outcome), and post traumatic stress, mindfulness, coping, social support and other relevant outcomes (secondary outcomes); and 2) assess mechanisms (mediators and moderators) of improvement after intervention. We will enroll and randomly assign 194 at risk dyads (97 per study group) to receive either the active intervention or educational control. The trial is single blinded (assessors, patients and staff). The trial will take place at the Massachusetts General Hospital NICU using our established methodology successfully implemented during the R21 pilot study. Study clinicians will deliver 6, 30 minute sessions of active intervention or educational control (2 at bedside and 4 via live video after discharge) to each patient-caregiver dyad. All participants will complete measures at baseline, after completion of program (6 weeks) and 3 months later. They will also complete measures of emotional distress weekly, as well as measures assessing home practice.

Connect with a study center

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital (MGH)

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

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