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

Emotional Distress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05157880
• Other study ID #: 2021P001943
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Ana-Maria Vranceanu, PhD
• Phone: 617-724-4977
• Email: avranceanu[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 388
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emotional Distress
• Trauma, Nervous System

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Change in Degree of disability or dependence (potential moderator)	Modified Rankin; 0-6, higher scores indicate greater disability	0 weeks, 6 weeks, 3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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