Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries

Conditions

• Trauma, Brain

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• CG-Well — BEHAVIORAL
  CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support
• Information Support & Referral (ISR) — BEHAVIORAL
  Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Study Details

After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.

Key Dates

Start date

Aug 16, 2021

Status verified

Mar 2025

Primary completion

Oct 1, 2025

Completion

Oct 1, 2025

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: CG-Well
  CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support
• Placebo Comparator: Information Support and Referral
  Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Primary Outcome Measure

Intervention Satisfaction [ Time Frame: 6 months ]

Central Contacts

• Emily Werff
  513-307-2963
  [email protected]
• Stephanie Thomas
  513-315-4001
  [email protected]

Locations (1)

Find similar trials in Cincinnati, OH

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