Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal… (NCT05157880) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Building Resiliency in Dyads of Patients With an ANI Admitted to the Neuro-ICU and Their Informal Caregivers
United States388 participantsStarted 2021-12-10
Plain-language summary
The purpose of the present investigation is to test the efficacy of a brief (6 sessions) dyadic (patient and caregiver together) intervention to prevent chronic emotional distress in at risk dyads admitted to a Neuroscience Intensive Care Unit with an acute brain injury. Through this study, we seek to solve the unmet need of preventing chronic emotional distress in Neuroscience Intensive Care Unit (NICU) dyads through a feasible, acceptable and credible program, and ideally improve the recovery trajectory and dyads' overall quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18 or older
* English fluency and literacy
* Patient with an informal caregiver available and willing to participate
* Hospitalized with any ANI within 6 weeks (patient) OR informal caregiver of a patient currently admitted with any ANI
* Patient and/or caregiver exhibit emotional distress on screening (using HADS D and/or HADS A scores \> 7)
Exclusion Criteria:
* Permanent cognitive impairment (including severe hearing impairment) or aphasia that makes participation impossible
* Short form of Mini-Mental State Exam (SMMSE) score \<4 (If SMMSE \<4, nursing team decides whether or not the patient can meaningfully participate)
* Glasgow Coma Scale (GCS) score \<10
* Terminal diagnosis
* Lack of access to internet and/or a device with a camera
* Current untreated or unstable severe mental health conditions like bipolar disorder, schizophrenia, or active substance use
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.