Skills-Based Resiliency Program for Caregivers of Coma Patients

(COMA-F Trial)

Overseen By Ana-Maria Vranceanu, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to pilot a psychosocial skills-based intervention for caregivers of patients with severe acute brain injuries. The data the investigators gather in this study will be used to further refine our COMA-F intervention.

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 data supports the effectiveness of the treatment COMA-F, COMA Family Program, COMA-F Intervention?

The COMA-F program is a mindfulness-based resiliency intervention designed to help caregivers of coma patients manage emotional distress. Similar programs, like the dyadic resiliency intervention for neuro-ICU survivors and their caregivers, have shown improvements in emotional distress and quality of life, suggesting potential benefits for the COMA-F program as well. ^{1 2 3 4 5}

Is the Skills-Based Resiliency Program for Caregivers of Coma Patients safe?

The COMA-F program, a mindfulness-based resiliency intervention for caregivers of patients with severe brain injuries, is designed to help manage emotional distress. While specific safety data for this program isn't detailed, mindfulness-based interventions are generally considered safe for most people. ^{2 4 6 7 8}

How is the COMA-F treatment different from other treatments for caregivers of coma patients?

The COMA-F treatment is unique because it is a mindfulness-based resiliency program specifically designed for caregivers of coma patients, focusing on reducing their emotional distress, unlike other treatments that may not specifically target mindfulness or resiliency. ^{1 2 3 9 10}

Eligibility Criteria

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 a caregiver and I am 18 years old or older.

My caregiver speaks English.

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

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

2. Canada 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effects of Counseling on Psychological Measures in Caregivers of Patients with Disorders of Consciousness. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Family and TBI: an investigation using the Family Outcome Measure - FOM-40. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Thematic Analysis of Psychosocial Stressors and Adaptive Coping Strategies Among Informal Caregivers of Patients Surviving ICU Admission for Coma. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Resilience-enhancing interventions for family caregivers: A systematic review. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. [2015]

8. England pubmed.ncbi.nlm.nih.gov

Testing an Intervention to Improve Posthospital Outcomes in Persons Living With Dementia and Their Family Care Partners. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Effectiveness of Supportive Educative Learning programme on the level of strain experienced by caregivers of stroke patients in Thailand. [2016]

10. England pubmed.ncbi.nlm.nih.gov

Tracking patterns of needs during a telephone follow-up programme for family caregivers of persons with stroke. [2018]