Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention

Not Applicable

Recruiting

• Conditions: Caregiver Burnout; Caregiver Burden; Caregiver Stress Syndrome
• Interventions: Other: TBI-AD/ADRD Caregiver Support Intervention (TACSI)

• Registration Number: NCT05465109
• Lead Sponsor: University of Minnesota

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• the care recipient has a physician diagnosis of TBI and AD/ADRD (i.e., those with a diagnosis of both TBI and progressive cognitive decline)
• the caregiver self-identifies as someone who provides the most help/is most responsible for the person with TBI-AD/ADRD because of their cognitive impairments (or shares the role equally with another caregiver)
• the caregiver indicates a willingness to participate in the TACSI evaluation
• the caregiver is English speaking
• the caregiver is 21 years of age or older
• the caregiver is not currently participating in any other type of service that provides one-to-one psychosocial consultation or caregiver coaching (peer mentorship/support group participation/general counseling not specific to caregiving is not a deterrent to enrollment) at the discretion of the UMN research team
• the caregiver resides in the US.

Exclusion Criteria

• caregivers who have a new or worsening mental health condition and are not receiving ongoing treatment. When applicable, if caregivers have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics or anti-psychotics, for the prior three months they will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TACSI	TBI-AD/ADRD Caregiver Support Intervention (TACSI)	-

Primary Outcome Measures

Name	Time	Method
Caregiver primary subjective stress- Phase 2, 3mo	change in score from baseline to 3 months	Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 2, 6mo	change in score from baseline to 6 months	Change in score from baseline to Module 6
Caregiver primary subjective stress- Phase 1	change in score from baseline to 3 months	Change in score from baseline to Module 6

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States