Recovering Together for Neurological Injury

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive impairment, Aphasia, Terminal diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

388 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called "Recovering Together," designed to prevent long-term emotional distress in people with sudden brain injuries and their caregivers. Participants will attend six sessions: two general and four personalized, focusing on education or skill-building. It targets patients and caregivers managing stress after a recent brain injury and those able to join online sessions. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in emotional recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for patient-caregiver dyads?

Research shows that the "Recovering Together" program supports both the patient and their caregiver. This approach, known as a dyadic intervention, targets individuals with sudden brain injuries. Studies have found that involving caregivers in treatment can be beneficial.

In terms of safety, the program emphasizes education and skills training rather than medication or medical procedures. This generally results in fewer risks or side effects compared to medical treatments. Participants might feel more at ease knowing the program focuses on learning and support.

While specific data on the safety of "Recovering Together" is not available, this type of program is typically well-received. It aims to enhance emotional well-being, which can help reduce stress and anxiety. For any concerns, discussing them with the trial team or a healthcare professional is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Recovering Together" protocol because it offers a fresh approach to supporting patients with neurological injuries and their caregivers. Unlike traditional methods that focus primarily on patient rehabilitation, this protocol emphasizes the importance of the caregiver-patient relationship. The program includes interactive sessions that can be personalized and delivered through live video, making it more flexible and accessible. By incorporating skill-building exercises and educational content tailored to the needs of each dyad, it aims to enhance both recovery and emotional well-being, potentially improving outcomes beyond what current care practices offer.

What evidence suggests that the "Recovering Together" intervention could be effective for preventing chronic emotional distress in NICU dyads?

Research has shown that the "Recovering Together" program can help prevent ongoing emotional distress in patients and caregivers dealing with sudden brain injuries. In this trial, participants will join either the Experimental Patient-Caregiver Dyads arm, which focuses on skills-based sessions, or the Control Patient-Caregiver Dyads arm, which provides educational content. Studies have found that when patients and caregivers work together as a pair, their emotional well-being improves. This approach involves providing mental and social support in the intensive care unit. Early findings suggest that by working together, patients and caregivers can better handle stress and emotional challenges. The program aims to enhance overall quality of life by offering personalized support and skills. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for pairs of patients with acute neurological injuries (ANI) in the Neuro-ICU and their informal caregivers. Participants must be over 18, speak English, and have internet access. They should show signs of emotional distress but not have severe mental health conditions or cognitive impairments that would hinder participation.

Inclusion Criteria

Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores > 7)

I was hospitalized for an acute neurological incident within the last 6 weeks OR I am caring for someone who is.

English fluency and literacy

Exclusion Criteria

Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use

I do not have severe cognitive issues or speech problems that would prevent me from participating.

Terminal diagnosis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dyadic intervention consisting of 6 sessions to prevent chronic emotional distress

6 weeks

2 visits (in-person or virtual), 4 visits (virtual)

Follow-up

Participants are monitored for emotional distress and other outcomes after treatment

3 months

Assessments at baseline, 6 weeks, and 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Recovering Together

Trial Overview 'Recovering Together' is a brief intervention program being tested to see if it can prevent long-term emotional distress in patient-caregiver dyads dealing with ANI. The study involves six sessions aimed at improving recovery outcomes and overall quality of life.

How Is the Trial Designed?

Group I: Experimental Patient-Caregiver Dyads Experimental Treatment 1 Intervention

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.

Group II: Control Patient-Caregiver Dyads Active Control 1 Intervention

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.

Recovering Together is already approved in United States for the following indications:

Approved in United States as Recovering Together for:

• Prevention of chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

The intervention aimed at improving the alliance between the interdisciplinary team and clients with traumatic brain injury resulted in the treatment group showing higher functional status at discharge compared to the control group, indicating its potential efficacy.

A stronger team alliance was linked to better outcomes, including program completion, return to productivity, improved client relationships, reduced family discord, and fewer depressive symptoms, suggesting that enhancing team dynamics can positively impact recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an interdisciplinary team intervention to improve therapeutic alliance in post-acute brain injury rehabilitation. Evans, CC., Sherer, M., Nakase-Richardson, R., et al.[2019]

The IMPROVE study is a longitudinal, multicenter research project that will follow stroke patients for up to one year after inpatient rehabilitation to better understand their long-term functional recovery and the factors influencing it.

The primary outcome will focus on hand motor function, measured by the Fugl-Meyer Assessment, providing objective data on recovery dynamics and helping to inform future rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). Birke, G., Wolf, S., Ingwersen, T., et al.[2022]

Involving patients in multidisciplinary goal setting during early rehabilitation after brain injury significantly increased the number of goals set per patient, from an average of 6.3 to 8.05, indicating enhanced engagement in their recovery process.

The intervention also led to a broader range of goals being established, particularly in areas like sleep and continence, without compromising the achievability of these goals, as the proportion of goals achieved remained consistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient inclusion in goal setting during early inpatient rehabilitation after acquired brain injury. Dalton, C., Farrell, R., De Souza, A., et al.[2019]

In a study involving 116 patients across five rehabilitation facilities, common goals included improvements in walking, recreation, leisure, pain management, and transfers, highlighting the importance of patient-centered goal setting in rehabilitation.

Despite identifying and structuring patient goals using the International Classification of Functioning, Disability and Health (ICF), achieving these goals did not predict overall improvements in functioning, suggesting that other factors may also play a significant role in rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ICF forms a useful framework for classifying individual patient goals in post-acute rehabilitation. Lohmann, S., Decker, J., Müller, M., et al.[2019]

The study revealed that the structure and composition of neurological rehabilitation teams varied significantly, with inconsistencies in the adoption of interdisciplinary teamwork and patient involvement across different teams.

Therapists recognized the potential benefits of teamwork in rehabilitation, but the actual implementation of team processes was complex and diverse, indicating a need for more standardized approaches in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapists' experiences and perceptions of teamwork in neurological rehabilitation: reasoning behind the team approach, structure and composition of the team and teamworking processes. Suddick, KM., De Souza, L.[2019]

Evidence-based interventions in neurological rehabilitation, such as constraint-induced movement therapy (CIMT) and robot-assisted training, have significantly improved motor functions and quality of life for patients with conditions like stroke and multiple sclerosis, as demonstrated through various therapeutic strategies over the past 20 years.

Early and frequent speech and language therapy (SLT) is crucial for effective recovery from communicative disorders, with PC-assisted training enhancing outcomes, highlighting the importance of tailored rehabilitation approaches for cognitive and communicative impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[DGRW-update: neurology--from empirical strategies towards evidence based interventions]. Schupp, W.[2011]

The article highlights the effectiveness of an interdisciplinary team approach in neurological rehabilitation services in North America, which enhances patient outcomes.

It provides a detailed description of the structure of the neurological rehabilitation team, emphasizing the collaboration among various healthcare professionals to optimize rehabilitation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Patient rehabilitation in Canada and the USA]. Marchuk, G., Tizel, P.[2016]

The Brain Recovery Core system is a new organized approach to stroke rehabilitation that spans from hospital admission to community discharge, aiming to improve patient outcomes.

This multidisciplinary effort has led to significant changes in how rehabilitation services are delivered, enhancing the overall effectiveness of stroke recovery programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The brain recovery core: building a system of organized stroke rehabilitation and outcomes assessment across the continuum of care. Lang, CE., Bland, MD., Connor, LT., et al.[2019]

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