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Caregiver Support Intervention for Caregiver Stress Syndrome (TACSI Trial)

N/A

Recruiting

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in score from baseline to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at a new intervention to help caregivers of people with both traumatic brain injury and dementia. The intervention includes helping caregivers identify stressors and developing better coping and communication strategies.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since TACSI is a supportive educational intervention rather than a medication or medical procedure, it does not have physical side effects but may bring emotional discomfort as sensitive topics are discussed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in score from baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in score from baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in score from baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Caregiver primary subjective stress- Phase 1

Caregiver primary subjective stress- Phase 2, 3mo

Caregiver primary subjective stress- Phase 2, 6mo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Do I qualify?Apply below to find out