Skills-Based Resiliency Program for Caregivers of Coma Patients

(COMA-F Trial)

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Terminal diagnosis, No internet access, Severe mental health, others

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

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a skills-based program designed to help caregivers of patients with severe brain injuries. The main goal is to teach resilience skills to reduce emotional distress. Suitable participants are primary caregivers of ICU patients with severe brain injuries who can communicate in English. The trial includes six 30-minute sessions with a clinical psychologist to help caregivers manage stress. This program is called the COMA-F Intervention. As an unphased trial, it offers caregivers a unique opportunity to gain valuable skills and support.

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 the COMA-F intervention is safe for caregivers?

Research has shown that the COMA-F program is safe for caregivers. In earlier studies, caregivers who participated in COMA-F experienced reduced emotional stress and improved coping skills. The program proved practical and useful, as most participants could complete it and found it beneficial. No reports of harm or negative side effects emerged from the program. Overall, COMA-F appears to be a well-received and helpful program for caregivers of patients with severe brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Skills-Based Resiliency Program for caregivers of coma patients because it focuses on building emotional resilience, which isn't typically addressed by standard medical care. Unlike usual treatments that concentrate on the patient's physical recovery, this approach provides caregivers with practical skills to manage stress and prevent long-term emotional distress. The program is delivered through short, focused 30-minute sessions led by a clinical psychologist, making it a convenient and targeted support system that can offer significant mental health benefits.

What evidence suggests that the COMA-F intervention is effective for caregivers of coma patients?

Research shows that the COMA-F program, which participants in this trial will receive, helps caregivers of coma patients. Studies have found that this program lowers emotional stress and improves coping skills. A small initial study showed promising results, with caregivers reporting better stress management. The program uses mindfulness, which involves staying calm and focused on the present moment, to help reduce anxiety. Overall, early results suggest that COMA-F can offer valuable support to those caring for loved ones with severe brain injuries. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for caregivers over 18 years old who speak English and are the primary caregiver of a patient with severe acute brain injury (like stroke or trauma) in ICU. The patient must be unable to communicate, have a low Glasgow Coma Scale score due to the injury, and expected to live more than 3 months without terminal illness.

Inclusion Criteria

I am caring for someone with a severe brain injury who cannot communicate.

I am the main caregiver for someone over 18 with a severe brain injury currently in ICU.

Exclusion Criteria

The person taking care of the patient has serious mental health issues that are not being treated or are not stable.

The patient has a very serious illness that cannot be cured.

Caregiver has lack of access to internet and/or a device with a camera

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Caregivers participate in 6, 30-minute skills sessions delivered by a clinical psychologist to provide resiliency skills

6 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for emotional distress and provide feedback through exit interviews

1 week

1 exit interview (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• COMA-F

Trial Overview

The COMA-F program is being tested as an intervention for caregivers. It's designed to help them develop skills to handle emotional distress while caring for loved ones with severe brain injuries. This pilot study will refine the program based on participant feedback.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Caregivers will participate in 6 30-minute skills sessions. A clinical psychologist will deliver all of the sessions. The main intervention goal is to provide dyads with resiliency skills to reduce emotional distress and prevent chronic distress.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The Recovering Together (RT) intervention showed significant improvements in quality of life (QoL) for survivors of acute neurological illness, particularly in physical health, environmental factors, general QoL, and QoL satisfaction, with these benefits lasting for at least 3 months after treatment.

Despite the positive outcomes for survivors, caregivers did not experience significant improvements in QoL compared to the control group, indicating a need for further research to evaluate the effectiveness of RT for both parties involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a Dyadic Resiliency Program Improve Quality of Life in Cognitively Intact Dyads of Neuro-ICU Survivors and Informal Caregivers? Results from a Pilot RCT. Lester, EG., Mace, RA., Bannon, SM., et al.[2022]

The Brain Injury Family Intervention significantly improved caregiver outcomes, including increased satisfaction with services and reduced caregiver burden, after five 2-hour sessions with 108 families participating in the study.

The benefits of the intervention were observed up to 3 months post-treatment, indicating its effectiveness in addressing the needs of family caregivers after acquired brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. Kreutzer, JS., Marwitz, JH., Sima, AP., et al.[2015]

The COMA Family (COMA-F) program is a mindfulness-based intervention designed to help caregivers of patients with severe acute brain injuries (SABI) manage chronic emotional distress, with a pilot trial involving 15 caregivers planned to assess its feasibility and acceptability.

The intervention will include 6 sessions focusing on resilience skills such as mindfulness and effective communication, with outcomes measured through self-report assessments of emotional distress and resilience before and after the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mindfulness-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injury Transitioning Out of Critical Care: Protocol for an Open Pilot Trial. Presciutti, AM., Woodworth, E., Rochon, E., et al.[2023]

A nurse-led Supportive Educative Learning programme (SELF) significantly improved the quality of life and reduced strain for family caregivers of stroke survivors in Thailand, as shown by a study involving 140 caregiver-patient pairs.

Caregivers who participated in the SELF programme reported better outcomes at both discharge and three months post-discharge compared to those receiving usual care, highlighting the importance of education and support in managing caregiver challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Supportive Educative Learning programme on the level of strain experienced by caregivers of stroke patients in Thailand. Oupra, R., Griffiths, R., Pryor, J., et al.[2016]

Psychological support significantly improves the emotional well-being of caregivers for patients with disorders of consciousness (DOC), as shown in a study involving 48 caregivers over a 6-month period.

The effectiveness of this support was consistent regardless of whether the patient was in a vegetative state or a minimally conscious state, indicating its broad applicability in caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Counseling on Psychological Measures in Caregivers of Patients with Disorders of Consciousness. Corallo, F., Bonanno, L., De Salvo, S., et al.[2015]

In a study of 38 family members supporting relatives with traumatic brain injury (TBI), living in shared supported accommodation (SSA) was linked to lower family burden, while living at home was associated with better adjustment for the relative with TBI.

Family resilience was found to positively impact the sustainability of support and the presence of comorbidities in the relative, highlighting the importance of family dynamics in the care of individuals with high support needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family and TBI: an investigation using the Family Outcome Measure - FOM-40. Migliorini, C., Callaway, L., Moore, S., et al.[2020]

A study involving 30 family caregivers of patients with severe acute brain injury revealed that caregivers experience significant emotional distress due to practical, social, and emotional stressors, particularly in the ICU setting.

Caregivers often resorted to avoidance and distraction as initial coping strategies, but struggled to implement more effective strategies like cultivating positive emotions and seeking support due to their heightened emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thematic Analysis of Psychosocial Stressors and Adaptive Coping Strategies Among Informal Caregivers of Patients Surviving ICU Admission for Coma. Hwang, DY., Bannon, SM., Meurer, K., et al.[2023]

Family-centered Function-focused Care (Fam-FFC) significantly improved the likelihood of hospitalized patients with dementia returning to their baseline physical function, with a twofold increase compared to the control group over 6 months.

Fam-FFC also led to a reduction in behavioral symptoms of distress, indicating its potential effectiveness in enhancing the overall well-being of both patients and their family care partners during and after hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an Intervention to Improve Posthospital Outcomes in Persons Living With Dementia and Their Family Care Partners. Boltz, M., Mogle, J., Kuzmik, A., et al.[2023]

A study involving 123 stroke caregivers revealed that their perceived needs evolved over time, with the highest priority initially being information about stroke, followed by managing the survivor's emotions and behaviors in subsequent sessions.

The intervention, consisting of eight weekly telephone sessions, highlighted the importance of timely support for caregivers, allowing them to effectively address their own health needs later in the program, which is crucial for sustaining support for stroke survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tracking patterns of needs during a telephone follow-up programme for family caregivers of persons with stroke. Bakas, T., Jessup, NM., McLennon, SM., et al.[2018]

Psychoeducation, mindfulness-based interventions, and cognitive behavioral therapy (CBT) have shown promise in enhancing resilience among family caregivers, based on a review of six studies, four of which were randomized controlled trials.

Despite these positive findings, the overall quality of the studies was low to moderate, and there is still uncertainty about the most effective intervention and dosage for improving caregiver resilience, highlighting the need for more rigorous research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resilience-enhancing interventions for family caregivers: A systematic review. Chi, NC., Han, S., Lin, SY., et al.[2023]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37878376/

A Mindfulness-Based Resiliency Program for Caregivers of ...

To address this need, we developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers.

2.

med.unc.edu

med.unc.edu/neurology/coma-f-pilot-study-shows-promise-in-supporting-caregivers-of-icu-survivors-with-severe-brain-injury/

COMA-F Pilot Study Shows Promise in Supporting ...

A pilot study of the COMA-F program shows promising results in reducing emotional distress and improving coping skills among caregivers of ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10632918/

A Mindfulness-Based Resiliency Program for Caregivers of ...

We developed the Coma Family (COMA-F) program, a mindfulness-based resiliency intervention for these caregivers.

4.

researchgate.net

researchgate.net/publication/395875958_Multisite_Open_Pilot_Trial_of_a_Resilience_Intervention_for_Caregivers_of_Patients_with_Severe_Acute_Brain_Injury_The_Coma_Family_Program

Multisite Open Pilot Trial of a Resilience Intervention for ...

COMA-F exceeded feasibility and acceptability benchmarks (≥ 70% on all) and showed improvements in emotional distress, dispositional mindfulness ...

5.

med.unc.edu

med.unc.edu/neurology/hwang-receives-grant-to-study-emotional-support-intervention-for-caregivers-of-patients-surviving-icu-admission-for-coma/

Hwang Receives Grant to Study Emotional Support ...

Over the course of the grant, the team will recruit 15 caregivers of severe acute brain injury patients undergoing tracheostomy and gastrostomy ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40999289/

Multisite Open Pilot Trial of a Resilience Intervention for ...

Caregivers endorsed elevated distress on the Hospital Anxiety and Depression Scale (HADS), and patients suffered coma for ≥ 24 hours and were ...

7.

withpower.com

withpower.com/trial/phase-brain-injuries-1-2023-480e7

Skills-Based Resiliency Program for Caregivers of Coma ...

The COMA Family (COMA-F) program is a mindfulness-based intervention designed to help caregivers of patients with severe acute brain injuries (SABI) manage ...