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Completed

NCT Number: NCT05465109

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

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Brain Diseases Brain Injuries Brain Injuries, Traumatic Caregiver Burnout Caregiver Stress Syndrome Central Nervous System Diseases Craniocerebral Trauma Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Stress, Psychological Trauma, Nervous System Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TBI-AD/ADRD Caregiver Support Intervention (TACSI)

Other

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. This intervention offers individual and family coaching and knowledge and skills to help manage stress and reduce caregiver burden.

Primary outcomes

  1. Caregiver primary subjective stress- Phase 1

    Time frame: change in score from baseline to 3 months

    Change in score from baseline to Module 6

  2. Caregiver primary subjective stress- Phase 2, 3mo

    Time frame: change in score from baseline to 3 months

    Change in score from baseline to Module 6

  3. Caregiver primary subjective stress- Phase 2, 6mo

    Time frame: change in score from baseline to 6 months

    Change in score from baseline to Module 6

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Congressionally Directed Medical Research Programs
  • Mayo Clinic
  • Minneapolis Veterans Affairs Medical Center
  • United States Department of Defense

Registry information

Official study title

Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD

Acronym: TACSI

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2022
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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