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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Recovering Together: Building Resiliency in Dyads of Patients With an Acute Brain Injury Admitted to the Neuroscience Intensive Care Unit and Their Informal Caregivers

Conditions
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Acute Neurological Injury, Emotional Distress

Intervention / Treatment
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* Behavioral: Recovering Together
* Behavioral: Recovering Together


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Patient-Caregiver Dyads<br>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. | Behavioral: Recovering Together<br>* 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.<br>* Other names: Skills-based intervention;|
| Active Comparator: Control Patient-Caregiver Dyads<br>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. | Behavioral: Recovering Together<br>* 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.<br>* Other names: Educational program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Emotional Distress | Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression | 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Post-Traumatic Stress | Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress | 0 weeks, 6 weeks, 3 months | 
| Change in Resiliency Factors (Mindfulness - curiosity and de-centering) | Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering) | 0 weeks, 6 weeks, 3 months | 
| Change in Resiliency Factors (Mindfulness) | Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness | 0 weeks, 6 weeks, 3 months | 
| Change in Resiliency Factors (Individual Coping) | Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope | 0 weeks, 6 weeks, 3 months | 
| Change in Resiliency Factors (Dyadic Coping) | Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship | 0 weeks, 6 weeks, 3 months | 
| Change in Interpersonal Factors (perceived social support) | Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support | 0 weeks, 6 weeks, 3 months | 
| Change in Interpersonal Factors (avoidant or anxious communication) | Experiences in Close Relationships Scale short form (ECR-S); 7-42, higher scores indicate greater avoidant or anxious communication | 0 weeks, 6 weeks, 3 months | 
| Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions) | Dyadic Relationship Scale (DRS); Patient version: 10-40, caregiver version: 11-44, dyadic strain subscale: higher scores indicate greater levels of strain, positive dyadic interaction subscale: higher scores indicate greater levels of positive interaction | 0 weeks, 6 weeks, 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neurological Injury, Emotional Distress, Dyadic Intervention