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

95 Participants Needed

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.

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 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. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment TBI-AD/ADRD Caregiver Support Intervention (TACSI) for caregiver stress syndrome?

Research shows that caregivers of people with traumatic brain injury (TBI) and Alzheimer's disease face high stress and health issues. Interventions like TACSI, which provide support and education, can help reduce caregiver stress and improve their well-being. ^{1 2 3 4 5}

What 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. ^{1 3 6 7 8}

Is 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. ^{1 3 5 6 8}

How is the TACSI treatment different from other treatments for caregiver stress syndrome?

The TACSI treatment is unique because it focuses on providing comprehensive support for caregivers of individuals with traumatic brain injury (TBI) and Alzheimer's disease-related dementias (ADRD), addressing both cognitive and behavioral symptom management and care coordination. Unlike other treatments, it emphasizes interdisciplinary care and support for caregivers, aiming to improve outcomes for both the patients and their caregivers. ^{1 3 5 6 8}

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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) 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]

References

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

Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. [2022]

2. United States 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. [2020]

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

Supporting caregivers of veterans with Alzheimer's disease and traumatic brain injury: study protocol for a randomized controlled trial. [2021]

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

Caregiver resilience following traumatic brain injury: Findings at six months postinjury. [2023]

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

Caregiver's Burden of the Patients With Traumatic Brain Injury. [2020]

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

Effectiveness of remote interventions in improving caregiver stress outcomes for caregivers of people with traumatic brain injury. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Caregivers' perspectives of the challenges faced with survivors of traumatic brain injury: A scoping review. [2021]

8. Nepal pubmed.ncbi.nlm.nih.gov

Traumatic brain injury: caregivers' problems and needs. [2012]