Caregiver Support Intervention for Caregiver Stress Syndrome

(TACSI Trial)

Overseen By Joseph E. Gaugler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Must not be taking: Antidepressants, Anxiolytics, Antipsychotics

Disqualifiers: New mental health condition, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist caregivers of family members with both traumatic brain injury (TBI) and dementia. It tests a new support program called the TBI-AD/ADRD Caregiver Support Intervention (TACSI), which combines emotional and educational assistance to reduce stress and improve caregiving skills. Participants will either try this new program or continue with their usual support services. This trial suits caregivers in the U.S. who are the primary helpers for someone with TBI and dementia and are not currently receiving one-on-one caregiver coaching. As an unphased trial, it offers caregivers a unique opportunity to explore innovative support strategies that could enhance their caregiving experience.

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.

Will 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 or anti-anxiety drugs), you must have been on a stable dose for the past three months to participate.

What prior data suggests that the TACSI intervention is safe for caregivers?

Research shows that the TBI-AD/ADRD Caregiver Support Intervention (TACSI) helps caregivers manage stress and lighten their load. Studies have examined the practicality and feasibility of this program for those caring for family members with both traumatic brain injury and dementia.

No evidence has emerged of harmful effects or negative experiences from participating in this support program. The program includes coaching and education, which are generally safe methods. As it focuses on support rather than medication or medical procedures, it is considered safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TACSI intervention for Caregiver Stress Syndrome because it takes a holistic approach to support caregivers, focusing on their unique challenges and needs. Unlike typical treatments that may only offer basic educational resources or support groups, TACSI provides a structured support system tailored specifically for caregivers of individuals with traumatic brain injury or Alzheimer's disease and related dementias. This intervention aims to reduce stress by combining personalized support with educational resources, potentially leading to better mental health outcomes for caregivers, which is a critical and often overlooked aspect of patient care.

What evidence suggests that the TACSI intervention is effective for caregiver stress syndrome?

Research has shown that the TBI-AD/ADRD Caregiver Support Intervention (TACSI), which participants in this trial may receive, can help reduce stress and burden for caregivers. Studies have found that programs like TACSI, focusing on emotional and educational support, improve caregivers' coping and communication skills. The intervention aims to boost caregivers' confidence and ability to manage caregiving challenges. Early results suggest that caregivers feel less exhausted and more supported. This approach specifically addresses the stress of caring for loved ones with traumatic brain injury and dementia. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

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.

The caregiver resides in the US.

I have been diagnosed with both traumatic brain injury and Alzheimer's or related dementia.

Exclusion Criteria

I am a caregiver with a new or worsening mental health issue and not on stable medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporating psychosocial and psychoeducational approaches

3 months

Follow-up

Participants are monitored for changes in caregiver primary subjective stress

3 months

Extended Follow-up

Participants are further monitored for changes in caregiver primary subjective stress

6 months

What Are the Treatments Tested in This Trial?

Interventions

• TBI-AD/ADRD Caregiver Support Intervention (TACSI)

Trial Overview 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.

How Is the Trial Designed?

Group I: TACSI Experimental Treatment 1 Intervention

Group II: Usual care control group Active Control 1 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.

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Minneapolis Veterans Affairs Medical Center

Collaborator

Trials

77

Recruited

355,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The ABC ANSWERS study is a randomized controlled trial involving 200 dyads of veterans with Alzheimer's disease or traumatic brain injury and their caregivers, aiming to improve caregiver quality of life and reduce caregiver burden over 12 months.

The intervention is based on evidence-based programs and is expected to enhance caregiver well-being by addressing psychological symptoms like depression and anxiety, compared to standard primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial. Carnahan, JL., Judge, KS., Daggy, JK., et al.[2021]

Caregivers of survivors with moderate to severe traumatic brain injury (TBI) face significant challenges, including psychological distress, financial burdens, and difficulties in social functioning, as identified in a review of 14 studies published between 1999 and 2018.

There is a notable lack of research on the experiences of these caregivers, especially in low- and middle-income countries, highlighting the need for more targeted studies to improve support systems for caregivers in diverse environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregivers' perspectives of the challenges faced with survivors of traumatic brain injury: A scoping review. Page, TA., Gordon, S., Balchin, R., et al.[2021]

Caregivers of traumatic brain injury (TBI) patients, especially spouses and females, experience significant psychological and health issues, highlighting the need for better support and education for these caregivers before patient discharge.

The D'Zurilla and Nezu social problem-solving model was identified as the most beneficial therapeutic intervention for caregivers, suggesting that structured support and counseling can help alleviate caregiver stress and improve family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver's Burden of the Patients With Traumatic Brain Injury. Qadeer, A., Khalid, U., Amin, M., et al.[2020]

Caregivers of patients with moderate-to-severe traumatic brain injury (TBI) showed significant improvements in meeting their emotional support needs and knowledge about brain injury after a 5-session intervention, compared to a control group.

However, the benefits of the intervention did not last at the 3-month follow-up, suggesting that caregivers may need ongoing support to maintain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Niemeier, JP., Kreutzer, JS., Marwitz, JH., et al.[2020]

Caregivers of traumatic brain injury (TBI) survivors, often family members, face significant challenges including emotional distress, financial strain, and a lack of information and support, which can greatly affect their well-being.

There is a critical need for better resources and support systems for TBI caregivers, particularly in developing countries, to address their needs for health information, financial assistance, and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traumatic brain injury: caregivers' problems and needs. Hassan, ST., Khaw, WF., Rosna, AR., et al.[2012]

Interventions specifically targeting family caregivers of adults with traumatic brain injury (TBI) are more effective in reducing caregiver burnout and improving well-being than those aimed at both caregivers and survivors or just the survivors themselves.

The review included 14 studies, primarily randomized clinical trials, but highlighted limitations such as small sample sizes and high risk of bias, suggesting that future research should focus on larger, more rigorously designed studies to better assess the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. Kreitzer, N., Kurowski, BG., Bakas, T.[2022]

A systematic review of 12 studies found that remote interventions, particularly online problem-solving modules, significantly reduced caregiver stress among those caring for individuals with traumatic brain injury (TBI), with 83.3% of studies reporting positive outcomes.

These online interventions were shown to be as effective as traditional in-person methods, suggesting a viable option for supporting caregivers facing financial, emotional, and physical stressors related to TBI care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of remote interventions in improving caregiver stress outcomes for caregivers of people with traumatic brain injury. Suntai, Z., Laha-Walsh, K., Albright, DL.[2021]

Caregivers of individuals with moderate-to-severe traumatic brain injury reported resilience levels comparable to community norms, indicating that they can maintain psychological strength despite their caregiving challenges.

The study found that meeting emotional support needs significantly contributes to caregiver resilience, suggesting that enhancing emotional support networks could improve outcomes for both caregivers and individuals with TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver resilience following traumatic brain injury: Findings at six months postinjury. Marwitz, JH., Perera, RA., Klyce, DW., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05465109

Study Details | NCT05465109 | Traumatic Brain Injury and ... This intervention offers individual and family coaching and knowledge and skills to help manage stress and reduce caregiver burden. Participant Group/Arm, No ...

2. academic.oup.com academic.oup.com/innovateage/article/doi/10.1093/geroni/igaf057/8166514

Traumatic Brain Injury-Alzheimer's Disease ... - Oxford Academic This study evaluated the feasibility of the TBI-AD/ADRD Caregiver Support Intervention (TACSI) psychoeducational program, designed to support ...

3. researchgate.net researchgate.net/publication/393105581_The_TBI-ADADRD_Caregiver_Support_Intervention_A_Mixed_Methods_Evaluation_of_Program_Feasibility_Acceptability_and_Utility

The TBI-AD/ADRD Caregiver Support Intervention Objective: This systematic review aimed to identify the consequences of Burnout Syndrome in informal caregivers of older adults with dementia.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7168967/

Supporting caregivers of veterans with Alzheimer's disease ... Caring for someone with ADRD or TBI is associated with higher rates of psychological morbidity and burden, social isolation, financial hardship, ...

5. withpower.com withpower.com/trial/phase-caregivers-burnout-6-2022-d2d40

Caregiver Support Intervention for Caregiver Stress Syndrome 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287695/

The Traumatic Brain Injury-Alzheimer's Disease and ... This study evaluated the feasibility of the TBI-AD/ADRD Caregiver Support Intervention (TACSI) psychoeducational program, designed to support the unique subset ...

7. trialx.com trialx.com/clinical-trials/listings/246145/traumatic-brain-injury-and-alzheimers-diseaserelated-dementias-caregiver-support-intervention/?&radius=50&query=Caregiver%20Burden&smt=true

Traumatic Brain Injury and Alzheimer's Disease/Related ... Clinical trial for Caregiver Stress Syndrome | Caregiver Burden | Caregiver Burnout , Traumatic Brain Injury and Alzheimer's Disease/Related Dementias ...