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

June 10, 2026 updated by: Ana-Maria Vranceanu, PhD, Massachusetts General Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Emotional Distress
Time Frame: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Post-Traumatic Stress
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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)
Time Frame: 0 weeks, 6 weeks, 3 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Demographic Factors (potential moderators)
Time Frame: 0 weeks
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)
Time Frame: 0 weeks, 6 weeks, 3 months
Barthel Score; 0-100, higher scores indicate greater independence
0 weeks, 6 weeks, 3 months
Change in Degree of disability or dependence (potential moderator)
Time Frame: 0 weeks, 6 weeks, 3 months
Modified Rankin; 0-6, higher scores indicate greater disability
0 weeks, 6 weeks, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

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