Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
Purpose
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.
Conditions
- Acute Neurological Injury
- Emotional Distress
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
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. |
|
Recruiting Locations
Boston, Massachusetts 02114
More Details
- Status
- Recruiting
- Sponsor
- Massachusetts General Hospital
Detailed 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.