Acute Neurological InjuryNCT05157880
Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
A study testing Recovering Together in people with Acute Neurological Injury and Emotional Distress, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Neurological Injury, Emotional Distress
- What is being tested?
- Recovering Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2021to 1 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital (MGH)
Boston, Massachusetts, 02114
About this study
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
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.
Read the 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.
- Conditions
- Acute Neurological Injury, Emotional Distress
- Being tested
- Recovering Together
- Keywords
- Neurological Injury, Emotional Distress, Dyadic Intervention
- Medical subject headings
- Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovering TogetherBehavioural
Also called Skills-based intervention
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 TogetherBehavioural
Also called Educational program
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Patient-Caregiver Dyads | Experimental | 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. Receives: Behavioral: Recovering Together |
| Control Patient-Caregiver Dyads | Active comparator | 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. Receives: Behavioral: Recovering Together |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 weeks, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 3 months
Secondary outcomes (8)
Change in Post-Traumatic Stress
Post-Traumatic Stress Disorder Checklist - Specific Event (PCL-S); 17-85, higher scores indicate greater post-traumatic stress
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 weeks, 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Dec 2021
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Neurological InjuryStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana-Maria Vranceanu, PhD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157880
- Sponsor's protocol ID
- 2021P001943
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2021
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vranceanu AM, Woodworth EC, Kanaya MR, Bannon S, Mace RA, Manglani H, Duarte BA, Rush CL, Choukas NR, Briskin EA, Cohen J, Parker R, Macklin E, Lester E, Traeger L, Rosand J; Neuro-ICU Recovering Together Team; Grunberg VA. The Recovering Together study protocol: A single-blind RCT to prevent chronic emotional distress in patient-cargiver dyads in the Neuro-ICU. Contemp Clin Trials. 2022 Dec;123:106998. doi: 10.1016/j.cct.2022.106998. Epub 2022 Nov 8.
PubMed 36368480