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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT05157880
Status
Recruiting
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Conditions

  • Acute Neurological Injury
  • Emotional Distress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Recovering Together — BEHAVIORAL
    In the skills-based intervention group, sessions focus on developing skills to cope and manage ANI related stressors. The intervention will be tailored consistent with AHA recommendations for ANI skills-based interventions and will include 2 general and 4 specific modules. It is anticipated that the intervention will have 6 sessions with 2 general sessions delivered, in person if possible, within the NICU, or through live video using Zoom if patients leave the hospital before sessions occur, and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom.
  • Recovering Together — BEHAVIORAL
    Those in the educational program will receive general health information that mimics the skills-based intervention, but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. There will also be 6 sessions, 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits following discharge. The educational program group will not have the opportunity to specify which modules they would like to take; the modules will be predetermined. All participants will receive medical care as determined by their medical team.

Study Details

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.

Key Dates

Start date
Dec 10, 2021
Status verified
Jun 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
388 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Patient-Caregiver Dyads
    There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily skills.
  • Active Comparator: Control Patient-Caregiver Dyads
    There will be 6 sessions with 2 general sessions delivered in person at bedside in the NICU (or virtual depending on COVID and discharge status) and 4 tailored specific sessions (chosen from by the dyads from 6 available modules) to be delivered via live video using Zoom. Content will be primarily educational.

Primary Outcome Measure

Change in Emotional Distress [ Time Frame: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital (MGH)BostonMassachusetts02114-

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By research site
Massachusetts General Hospital (MGH)· Boston, MA

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