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NCT Number: NCT05157880

Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Acute Neurological Injury Emotional Distress Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recovering Together

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Other outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2021
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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