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Behavioral Intervention

Skills-Based Resiliency Program for Caregivers of Coma Patients (COMA-F Trial)

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Caregivers must be age 18 or older

Caregivers must be English-speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-test (6 weeks after session 1)

Awards & highlights

COMA-F Trial Summary

This trial tests a new way of helping people caring for those with severe brain injuries to better manage their stress. Data gathered will help make the program better.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since COMA-F is a psychosocial skills-based intervention, it does not involve medication or medical procedures that typically cause side effects. However, discussing traumatic experiences could potentially lead to emotional discomfort.

COMA-F Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a caregiver and I am 18 years old or older.

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My caregiver speaks English.

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

COMA-F Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-test (6 weeks after session 1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-test (6 weeks after session 1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-test (6 weeks after session 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Preliminary feasibility of adherence

Preliminary feasibility of assessments

Preliminary feasibility of recruitment

+3 more

Other outcome measures

Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

Enhancing Recovery in Coronary Heart Disease Social Support Instrument (ESSI)

Hospital Anxiety and Depression Scale (HADS)

+3 more

COMA-F Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,504 Previous Clinical Trials

4,187,647 Total Patients Enrolled

1 Trials studying Coma

54 Patients Enrolled for Coma

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,340 Total Patients Enrolled

3 Trials studying Coma

113 Patients Enrolled for Coma

University of Maryland, BaltimoreOTHER

687 Previous Clinical Trials

374,631 Total Patients Enrolled

Media Library

COMA-F (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05761925 — N/A

Coma Research Study Groups: Intervention

Coma Clinical Trial 2023: COMA-F Highlights & Side Effects. Trial Name: NCT05761925 — N/A

COMA-F (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05761925 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining vacancies for participants in this medical experiment?

"According to the data hosted on clinicaltrials.gov, this particular medical study is not currently enrolling individuals; however, it was last edited on February 27th 2023. Luckily, there are 353 other trials that are accepting patients as of now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries

Ana-Maria Vranceanu, PhD 2024. "The COMA Family Program: A Skills-Based Resiliency Program for Caregivers of Patients With Severe Acute Brain Injuries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05761925.