Comparison of Two Group Wellness Interventions for Individuals with Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial

Study on Wellness Interventions for Neurologic Conditions and Caregivers

D
Devan Parrott

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase N/A
57 participants needed
2 Locations

Brief description of study

The goal of this study is to examine efficacy of the treatment in individuals with chronic mild TBI and their caregivers and to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers.  Beyond injury-based cohorts, we sought to examine whether WeCAN would be efficacious in a dementia population, particularly given the neuropathological link that predisposes individuals with TBI to ADRD in later life. 

THIS STUDY IS ENROLLING BY INVITATION ONLY - Patient/caregiver dyads will be recruited from participating sites. Recruitment will also be conducted via the Kessler Foundation recruitment database, connections with local clinics and support group organizations, posted flyers, and by other methods. At Indiana University (IU), research participants will be recruited from Regenstrief Institute referrals. Recruitment will also be conducted through Franciscan Health’s Comprehensive Outpatient Rehabilitation Program.

Detailed description of study

This study will evaluate the efficacy of WeCAN to improve self-efficacy and quality of life relative to an active peer support control post-treatment (week 13) and 6-month follow-up in individuals with chronic mild TBI, moderate to severe TBI, and dementia, and their caregivers. 

Each site will recruit 60 patient/caregiver dyads, who will be randomized to treatment (WeCAN) or control (Peer Support) conditions. Participants will be assessed at baseline, post-treatment, and at 6 months after treatment, with a primary focus on measures of self-efficacy and quality of life.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Traumatic brain injury, Chronic mild TBI, Moderate to severe TBI, Alzheimer’s disease and related Dementias, ADRD
  • Age: 18 years or above
  • Gender: All

Patient Participant inclusion criteria:

  • chronic mild TBI, moderate to severe TBI, or Alzheimer’s disease and Related Dementias
  • proficient in English
  • have no medical issues that would preclude group treatment engagement (e.g., uncontrolled seizures), other history of neurologic illness besides the diagnosis of primary interest
  • have no psychiatric hospitalizations within the past three months
  • possess adequate language comprehension to engage in group treatment based on either a  low average score on the NAB Auditory Comprehension subtest of Language Module or clinical neuropsychological judgment
  • be deemed low-moderate risk on the ASSIST for substance use disorders.

Caregiver Inclusion criteria

  • at least 18 years of age
  • proficient in English
  • an informal caregiver of an individual with the neurologic condition studied at that site
  • deemed low-moderate risk on the ASSIST for substance use disorders
  • have no psychiatric hospitalizations within the past three months
  • possess adequate language comprehension to engage in group treatment based on either a  low average score on the NAB Auditory Comprehension subtest of Language Module or clinical neuropsychological judgment

This study investigates the effectiveness of wellness interventions for people with neurologic conditions like chronic mild and moderate to severe traumatic brain injury (TBI) and dementia, along with their caregivers. The purpose is to see if these interventions can improve the quality of life and self-efficacy, which is the belief in one's ability to succeed in specific situations.

Participants will be divided into two study arms: one receiving the WeCAN treatment and the other receiving peer support. They will be assessed at the start, after the treatment, and six months later to measure changes in self-efficacy and quality of life.

  • Who can participate: Adults with chronic mild TBI, moderate to severe TBI, or Alzheimer's and related dementias, who are proficient in English and have no recent psychiatric hospitalizations, can participate. Caregivers must be at least 18 years old, proficient in English, and informal caregivers of the participants.
  • Study details: Participants will be divided into two groups: one will receive the WeCAN treatment, and the other will receive peer support. They will attend group sessions and be assessed on their self-efficacy and quality of life at different times.
Updated on 20 Jul 2026. Study ID: PHMR-KESSLER-WECAN, 30086
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Interested in the study?

This study is accepting only persons who receive care at a certain clinic or doctor or who are part of an invited group. Questions about this study can be directed to the study team listed in the description or contact your doctor to see if you are eligible.

Accepting Referrals by Invitation Only