Caregiver Support Intervention for Caregiver Stress Syndrome
(TACSI Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
No Placebo Group
Trial Summary
What is the purpose of this trial?The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy.
Do I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on psychotropic medications like antidepressants, anxiolytics, or anti-psychotics, you must have been on a stable dosage for the past three months to participate.
What data supports the idea that Caregiver Support Intervention for Caregiver Stress Syndrome is an effective treatment?
The available research shows that caregivers of individuals with traumatic brain injury (TBI) and Alzheimer's disease and related dementias (ADRD) face significant challenges, including psychological stress and social isolation. The studies highlight the need for interventions like the Caregiver Support Intervention to address these issues. While specific data on the effectiveness of this intervention is not provided, the research emphasizes the importance of support for caregivers to improve their well-being and resilience. Compared to other treatments, such as the D'Zurilla and Nezu social problem-solving model, which is noted as beneficial, the Caregiver Support Intervention is suggested to be a necessary approach to help caregivers manage stress and improve their quality of life.
12345What safety data exists for the Caregiver Support Intervention for Caregiver Stress Syndrome?
The provided research does not directly address safety data for the Caregiver Support Intervention for Caregiver Stress Syndrome or its variants like TACSI. The studies focus on the challenges and needs of caregivers for individuals with TBI and ADRD, the effectiveness of remote interventions, and the impact of caregiving. However, they do not provide specific safety data for the intervention itself.
13678Is the treatment TACSI a promising treatment for caregiver stress syndrome?
Yes, TACSI is a promising treatment because it focuses on supporting caregivers of people with traumatic brain injury and Alzheimer's disease. It aims to reduce stress, improve psychological well-being, and provide necessary support and education to caregivers, which are crucial for their health and the care they provide.
13568Eligibility Criteria
This trial is for caregivers over 21 years old in the U.S. who primarily assist a family member with both traumatic brain injury and dementia, are English-speaking, willing to participate, and not receiving similar psychosocial support elsewhere. Caregivers must be stable on any psychotropic medications for three months.Inclusion Criteria
I am willing to take part in the TACSI evaluation.
My caregiver speaks English.
The caregiver resides in the US.
+4 more
Exclusion Criteria
I am a caregiver with a new or worsening mental health issue and not on stable medication.
Participant Groups
The TACSI program is being tested to help caregivers of individuals with traumatic brain injury and dementia. It aims to identify caregiving stressors and teach effective coping, communication skills, and improve confidence in caregiving abilities.
2Treatment groups
Experimental Treatment
Active Control
Group I: TACSIExperimental Treatment1 Intervention
Group II: Usual care control groupActive Control1 Intervention
The usual care control group would have continued receipt of standard services at either the Mayo Clinic or the MVAHCS. In addition, staff will offer participants the opportunity to request supportive/educational resources as needed after randomization.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
Minneapolis Veterans Affairs Medical CenterCollaborator
Mayo ClinicCollaborator
United States Department of DefenseCollaborator
References
Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. [2022]To describe and synthesize the literature on adult traumatic brain injury (TBI) family caregiver and dyad intervention. TBI is a common injury that has a significant long-term impact, and is sometimes even characterized as a chronic condition. Informal (ie, unpaid) family caregivers of adults with TBI experience high rates of burnout, depression, fatigue, anxiety, lower subjective well-being, and poorer levels of physical health compared to noncaregivers. This study addresses the critical gap in the understanding of interventions designed to address the impact of TBI on adult patients and their family caregivers.
A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. [2020]Investigate effectiveness of a 5-session manualized intervention for addressing needs of caregivers of persons in acute traumatic brain injury (TBI) rehabilitation.
Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial. [2021]Patients with Alzheimer's disease and related dementias (ADRD) and traumatic brain injury (TBI) and their caregivers require cognitive and behavioral symptom management, interdisciplinary care, support for caregivers, and seamless care coordination between providers. Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, and deterioration of physical health. Tremendous need exists for primary care-based interventions that concurrently address the care needs of dyads and aim to improve care and outcomes for both individuals with ADRD and TBI and their family caregivers.
Caregiver resilience following traumatic brain injury: Findings at six months postinjury. [2023]Examine contributors to resilience among caregivers of individuals who have sustained a moderate-to-severe traumatic brain injury (TBI), with the goal of identifying important targets for an intervention to improve caregiver resilience as well as outcomes for people with TBI.
Caregiver's Burden of the Patients With Traumatic Brain Injury. [2020]Insufficient attention towards caregivers has resulted in the emergence of psychological and health complaints. Affliction tethers more towards spouses as compared to parents and females as compared to males. The role of sibling care givers was found to be no different from parents or spouses. Marital relationships were found to suffer the most, with the caregiver leaving the traumatic brain injury (TBI) patient in his time of need. The Brief Symptom Inventory (BSI) and family assessment device (FAD) predicted a correlation between patient variables and caregiver discontent. The Blacks/Hispanics proved to cope better with stress and their caregiver roles as compared to Whites. Time elapsed since the injury was found to relieve distress, while the surprising severity of the injury has no recorded impact. Social support or rather a lack of it has been seen to have an impact on family homeostasis, which can further be deteriorated by substance abuse by the patient. The therapeutic intervention found to be most advantageous was the D'Zurilla and Nezu social problem-solving model. Current evidence suggests that emphasis should be given on proper education and encouragement of caregivers before discharge of TBI patients from hospital to reduce the incidence of stressors. Additionally, counseling sessions should be led by professionally led support groups for dealing with psychological symptoms and peer-led group to eliminate social insecurities of caregivers.
Effectiveness of remote interventions in improving caregiver stress outcomes for caregivers of people with traumatic brain injury. [2021]Caregiver stress is the term used to define the adverse effects of caregiving, and its prevalence among caregivers of people with traumatic brain injury (TBI) is amplified by the suddenness of brain injury. This systematic review aimed to identify whether remote interventions can be helpful in minimizing those financial, emotional, and physical stressors associated with caring for a person with TBI.
Caregivers' perspectives of the challenges faced with survivors of traumatic brain injury: A scoping review. [2021]Traumatic brain injury (TBI) has wide-ranging neuropsychological, physical, social and financial implications. The impact on caregivers of moderate to severe TBI survivors, particularly in low- and middle-income countries, is under-investigated.
Traumatic brain injury: caregivers' problems and needs. [2012]Traumatic brain injury (TBI) is an increasingly major world health problem. This short review using the most pertinent articles on TBI caregiving problems and needs highlights the pressing issues. Articles focusing on both TBI-caregivers' problems and needs are rarely found, especially for developing countries. Most TBI-caregiving is done by family members, whose altered lives portend burden and stresses which add to the overwhelming demand of caring for the TBI-survivor. Lack of information, financial inadequacy, anxiety, distress, coping deficits, poor adaptability, inadequate knowledge and skills, and a poor support system comprise the major problems. Dysfunctional communication between caregivers and care-receivers has been little researched. The major needs are focused on health and rehabilitation information, financial advice and assistance, emotional and social support, and positive psychological encouragement. In time, health information needs may be met, but not emotional support. Information on TBI caregiving problems and unmet needs is critical to all relevant healthcare stakeholders.