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

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.

Study Overview

• Status: Recruiting
• Conditions: Emotional Distress; Acute Neurological Injury
• Intervention / Treatment: Behavioral: Recovering Together; Behavioral: Recovering Together

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.

• Study Type: Interventional
• Enrollment (Estimated): 388
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana-Maria Vranceanu, PhD; Phone Number: 617-724-4977; Email: avranceanu@mgh.harvard.edu
• Study Contact Backup: Name: Emily Woodworth, BA; Phone Number: 617-643-4123; Email: ewoodworth@mgb.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital (MGH)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Recovering Together; 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.; Other Names: Skills-based intervention; Behavioral: Recovering Together; 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.; Other Names: Educational program
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.	Behavioral: Recovering Together; 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.; Other Names: Skills-based intervention; Behavioral: Recovering Together; 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.; Other Names: Educational program

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Factors (potential moderators)	Age; biological sex; gender; race/ethnicity; educational level; employment status; occupation; income; marital status; prior ANI status; mental health history; psychotropic medications; medical comorbidities; satisfaction with medical staff (analog scale 0-10)	0 weeks
Change in Independence in activities of daily living (potential moderator)	Barthel Score; 0-100, higher scores indicate greater independence	0 weeks, 6 weeks, 3 months
Change in Degree of disability or dependence (potential moderator)	Modified Rankin; 0-6, higher scores indicate greater disability	0 weeks, 6 weeks, 3 months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (Actual): December 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Neurological Injury; Emotional Distress; Dyadic Intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System
• Other Study ID Numbers: 2021P001943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No