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

Primary Purpose

Acute Neurological Injury, Emotional Distress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovering Together
Recovering Together
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Neurological Injury focused on measuring Neurological Injury, Emotional Distress, Dyadic Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Current suicidal or homicidal ideation

Sites / Locations

  • Massachusetts General Hospital (MGH)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Patient-Caregiver Dyads

Control Patient-Caregiver Dyads

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Post-Traumatic Stress
Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress
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)
Change in Resiliency Factors (Mindfulness)
Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness
Change in Resiliency Factors (Individual Coping)
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Change in Resiliency Factors (Dyadic Coping)
Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship
Change in Interpersonal Factors (perceived social support)
Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support
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
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

Full Information

First Posted
October 28, 2021
Last Updated
February 10, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05157880
Brief Title
Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Neurological Injury, Emotional Distress
Keywords
Neurological Injury, Emotional Distress, Dyadic Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Patient-Caregiver Dyads
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Patient-Caregiver Dyads
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovering Together
Other Intervention Name(s)
Skills-based intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Recovering Together
Other Intervention Name(s)
Educational program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Emotional Distress
Description
Hospital Depression and Anxiety Scale total score (HADS); 0-21 for each subscale (anxiety and depression), higher scores indicate greater anxiety or depression
Time Frame
0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
Secondary Outcome Measure Information:
Title
Change in Post-Traumatic Stress
Description
Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Resiliency Factors (Mindfulness - curiosity and de-centering)
Description
Toronto Mindfulness Scale-Trait (TMS-Trait); 0-52, higher scores indicate greater perceived mindfulness (specifically curiosity and de-centering)
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Resiliency Factors (Mindfulness)
Description
Cognitive and Affective Mindfulness Scale (CAMS); 12-48, higher scores indicate greater perceived mindfulness
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Resiliency Factors (Individual Coping)
Description
Measure of Current Status Part A (MOCS-A); 0-52; higher scores indicate greater perceived ability to cope
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Resiliency Factors (Dyadic Coping)
Description
Dyadic Coping Inventory (DCI); 35-175; higher scores indicate greater perceived coping in the context of a relationship
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Interpersonal Factors (perceived social support)
Description
Interpersonal Support Evaluation List-12 (ISEL-12); 0-48, higher scores indicate greater perceived social support
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Interpersonal Factors (avoidant or anxious communication)
Description
Experiences in Close Relationships Scale short form (ECR-S); 7-42, higher scores indicate greater avoidant or anxious communication
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Interpersonal Factors (dyadic strain and positive interpersonal interactions)
Description
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
Time Frame
0 weeks, 6 weeks, 3 months
Other Pre-specified Outcome Measures:
Title
Demographic Factors (potential moderators)
Description
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)
Time Frame
0 weeks
Title
Change in Independence in activities of daily living (potential moderator)
Description
Barthel Score; 0-100, higher scores indicate greater independence
Time Frame
0 weeks, 6 weeks, 3 months
Title
Change in Degree of disability or dependence (potential moderator)
Description
Modified Rankin; 0-6, higher scores indicate greater disability
Time Frame
0 weeks, 6 weeks, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana-Maria Vranceanu, PhD
Phone
617-724-4977
Email
avranceanu@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Woodworth, BA
Phone
617-643-4133
Email
ewoodworth1@partners.org
Facility Information:
Facility Name
Massachusetts General Hospital (MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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