Acute Brain InjuriesNCT03694678

Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers

A study testing Recovering Together in people with Acute Brain Injuries, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Brain Injuries
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: 126 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2019to 11 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male and female patients, 18 years or older
English fluency and literacy
Access to high speed internet for video sessions
Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury
Either patient or caregiver within the dyads screens in for depression, anxiety, and/or PTSD

Who cannot join

Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers

The investigators will compare a dyadic intervention (Recovering Together) with an attention placebo educational control in dyads of patients with acute neurological illnesses and their caregivers at risk for chronic emotional distress. The primary aim of this study is to determine the feasibility, credibility, and satisfaction with Recovering Together. The second aim is to show proof of concept for sustained improvement in emotional distress, post traumatic stress (PTS), resiliency and interpersonal communication outcomes in patients and caregivers.

Read the detailed description

The investigators aim to improve the care of patients (pts) admitted to the Neuroscience Intensive Care Unit (NICU) and their family caregivers (cgs) by conducting a pilot feasibility randomized controlled trial (RCT; N=80 dyads; 60 completers) of the dyadic resiliency program ("Recovering Together") to prevent chronic emotional distress in both pts and their cgs. Eligible dyads include adult, English speaking pts with acute neurological injury (ANI) admitted to the NICU, cleared medically and cognitively for participation by the nursing team, and their primary cgs. Dyads who are randomly assigned to "Recovering Together" will receive 6 manualized sessions (2 in person at hospitalization and 4 through live video after discharge, to reduce burden and facilitate access to care) led by a clinical psychologist. Dyads who are randomly assigned to the attention placebo educational control condition will receive 6 manualized sessions (2 in person and 4 through live video with a clinical psychologist), modeled after the Recovering Together program that will control for the dose of the intervention and support from therapist. Dyads will complete assessment surveys before, after the intervention and 3 months later. Clinical data on demographics, diagnosis, ANI severity, and any medical complications will be extracted from electronic health records.

Conditions: Acute Brain Injuries
Being tested: Recovering Together
Keywords: Psychiatry, Dyads, Patients, Caregivers, Psychosocial
Medical subject headings: Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recovering TogetherBehavioural
The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions

Study groups in NCT03694678
Study group	Role	What they receive
Recovering Together	Experimental	Dyads who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, dyads will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS. Receives: Behavioral: Recovering Together
Health Education	No intervention	Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Recruitment (Ability to Recruit Dyads)
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Measured: Baseline
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Measured: Feasibility of program delivery will be measured at 6 weeks
Credibility and Expectancy Questionnaire
This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.
Measured: Baseline
Client Satisfaction Questionnaire
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Measured: post intervention (6 weeks after baseline)

Secondary outcomes (5)

Hospital Anxiety and Depression Scale
Measures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
Measured: baseline to posttest to 3 months follow up
Post Traumatic Checklist
The PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress.
Measured: baseline to posttest to 3 months follow up
Measures of Coping Style Part A
The MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills.
Measured: baseline to posttest to 3 months follow up
Cognitive and Affective Mindfulness Scale Revised
Measures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
Measured: baseline to post test to 3 months follow up
Dyadic Relationship Scale
The Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct.
Measured: Baseline, post treatment, 3-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201911 Oct 2020

First posted3 Oct 2018
Study start1 Jan 2019
Primary completion1 Oct 2020
Study completion11 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Acute Brain InjuriesStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694678
Sponsor's protocol ID: 2018P002187
Status last verified: May 2025
First submitted: 28 Sep 2018
Last updated: 28 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Brasil S, de Carvalho Nogueira R, Salinet ASM, Yoshikawa MH, Teixeira MJ, Paiva W, Malbouisson LMS, Bor-Seng-Shu E, Panerai RB. Critical Closing Pressure and Cerebrovascular Resistance Responses to Intracranial Pressure Variations in Neurocritical Patients. Neurocrit Care. 2023 Oct;39(2):399-410. doi: 10.1007/s12028-023-01691-8. Epub 2023 Mar 3.
PubMed 36869208
Bannon SM, Cornelius T, Gates MV, Lester E, Mace RA, Popok P, Macklin EA, Rosand J, Vranceanu AM. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial. Health Psychol. 2022 Apr;41(4):268-277. doi: 10.1037/hea0001102. Epub 2021 Sep 9.
PubMed 34498896
Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.
PubMed 33052404

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality

All Acute Brain Injuries trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Recovering Together: Building Resiliency in Dyads of Patients Admitted to the Neuroscience Intensive Care Unit (NICU) and Their Caregivers
ClinicalTrials.gov ID: NCT03694678
Acronym / sponsor ID: 2018P002187
Conditions: Acute Brain Injuries
Keywords: Psychiatry, Dyads, Patients, Caregivers, Psychosocial
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Oct 2020 (actual)
Study completion: 11 Oct 2020 (actual)
First posted: 3 Oct 2018 (actual)
Results: Posted 28 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Recovering Together	Experimental	Behavioral: Recovering TogetherDyads who are randomly assigned to the Recovering Together program will receive any usual clinic care as determined by their clinicians. Additionally, dyads will be invited to participate in 6 30-minute skills sessions. All sessions will include both pt and cg. A clinical psychologist will deliver the majority of sessions while the PI will deliver at least 10% of the sessions. The main intervention goal is to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Health Education	No intervention	–Patients randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Male and female patients, 18 years or older
English fluency and literacy
Access to high speed internet for video sessions
Patient with an informal cg (family or friend who provides unpaid care) available and willing to participate
Hospitalized with an acute brain injury within 1-2 days when first approached, OR the primary caregiver of a patient currently admitted with an acute brain injury

Key exclusion criteria (2 listed)

Permanent or severe cognitive impairment severe enough to impede participation - This will be determined by nurses through an assessment conducted as part of usual care (MMSE).
Dyads where the patient is anticipated to die or to never be able to participate due to medical sequelae.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Recovering TogetherThe intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions	Behavioural	Recovering Together

Primary outcome

Feasibility of Recruitment (Ability to Recruit Dyads)
Time frame: Baseline
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
Time frame: Feasibility of program delivery will be measured at 6 weeks
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Credibility and Expectancy Questionnaire
Time frame: Baseline
This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.
Client Satisfaction Questionnaire
Time frame: post intervention (6 weeks after baseline)
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

5 secondary outcomes

Hospital Anxiety and Depression Scale
Time frame: baseline to posttest to 3 months follow up
Post Traumatic Checklist
Time frame: baseline to posttest to 3 months follow up
Measures of Coping Style Part A
Time frame: baseline to posttest to 3 months follow up
Cognitive and Affective Mindfulness Scale Revised
Time frame: baseline to post test to 3 months follow up
Dyadic Relationship Scale
Time frame: Baseline, post treatment, 3-month follow-up

Results and safety

Results posted to the registry on 28 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Recovering Together	60	56
Health Education	62	59

Primary outcome: Feasibility of Recruitment (Ability to Recruit Dyads)

Time frame: Baseline. Count of participants. Unit: Participants

Measure	Eligible Participants n = 166
Participants who enrolled and randomized	122
Participants who declined	40
Participants who enrolled and did not randomize	4

Primary outcome: Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)

Time frame: Feasibility of program delivery will be measured at 6 weeks. Number. Unit: dyads

Measure	Recovering Together n = 30	Health Education n = 31
Number of dyads who started RT who had at least 1 member complete post treatment assessment	29	31
Number of dyads who started RT who had neither member complete post treatment assessment	1	0

Population analysed: Number of dyads who started RT who had at least 1 member complete post treatment assessment

Primary outcome: Credibility and Expectancy Questionnaire

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Recovering Together n = 58	Health Education n = 58
Credibility and Expectancy Questionnaire; credibility subscale	22.0 (4.4)	20.3 (4.8)
Credibility and Expectancy Questionnaire; expectancy subscale	19.0 (5.2)	19.5 (5.6)

Population analysed: Score on Credibility and Expectancy Questionnaire

Primary outcome: Client Satisfaction Questionnaire

Time frame: post intervention (6 weeks after baseline). Mean (Standard Deviation). Unit: score on a scale

Measure	Recovering Together n = 58	Health Education n = 58
Value	10.65 (1.18)	9.87 (2.70)

Population analysed: Score on Client Satisfaction Questionnaire

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Recovering Together: Patients	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Recovering Together: Caregivers	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Health Education: Patients	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Health Education: Caregivers	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36869208Brasil S, de Carvalho Nogueira R, Salinet ASM, Yoshikawa MH, Teixeira MJ, Paiva W, Malbouisson LMS, Bor-Seng-Shu E, Panerai RB. Critical Closing Pressure and Cerebrovascular Resistance Responses to Intracranial Pressure Variations in Neurocritical Patients. Neurocrit Care. 2023 Oct;39(2):399-410. doi: 10.1007/s12028-023-01691-8. Epub 2023 Mar 3.
Derived from this study: PubMed 34498896Bannon SM, Cornelius T, Gates MV, Lester E, Mace RA, Popok P, Macklin EA, Rosand J, Vranceanu AM. Emotional distress in neuro-ICU survivor-caregiver dyads: The recovering together randomized clinical trial. Health Psychol. 2022 Apr;41(4):268-277. doi: 10.1037/hea0001102. Epub 2021 Sep 9.
Derived from this study: PubMed 33052404Vranceanu AM, Bannon S, Mace R, Lester E, Meyers E, Gates M, Popok P, Lin A, Salgueiro D, Tehan T, Macklin E, Rosand J. Feasibility and Efficacy of a Resiliency Intervention for the Prevention of Chronic Emotional Distress Among Survivor-Caregiver Dyads Admitted to the Neuroscience Intensive Care Unit: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020807. doi: 10.1001/jamanetworkopen.2020.20807.
Individual participant dataSharing planned: No

Related trials for Acute Brain Injuries

RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ana-Maria Vranceanu, PhD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Recovering Together in people with Acute Brain Injuries, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Recruitment (Ability to Recruit Dyads) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694678, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.