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

DP

Devan Parrott

Principal Investigator

Status: Enrolling By Invitation Ages: 18 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

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

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

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

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Visit allinforhealth.info to see if you're eligible and join the study.