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Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two types of group wellness treatments. It is for people with lasting brain injuries or Alzheimer's disease and related dementias, which affect memory and thinking, and their support persons.

Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • People with a moderate or severe traumatic brain injury (TBI): ages 18–70, with at least 4 months since the injury.
  • People with a lasting mild TBI: ages 18–70, with at least 3 months since the injury.
  • People with Alzheimer's disease or related dementia: age 65 or older, with at least 1 year since diagnosis.
  • People with a brain injury or dementia must have a support person willing to join the study.
  • Support persons must support someone with one of these conditions who is willing to join the study.
  • Everyone must be able to read and speak English fluently.

Who can't join

  • For people with a brain injury or dementia: a past stroke or a brain or nerve disease other than the condition they are joining the study for.
  • For support persons: a major history of brain or nerve problems, such as stroke or multiple sclerosis.
  • For everyone: seizures that are unstable or not controlled.
  • For everyone: a hospital stay for a serious mental illness, such as bipolar disorder or schizophrenia, in the past 3 months.
  • For everyone: current alcohol or drug use that makes everyday tasks hard to do.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

For individuals with moderate/severe TBI: Inclusion Criteria: * age 18-70 * at least 4 months post injury * can read and speak English fluently * has a support person who is willing to participate in the study Exclusion Criteria: * has had a prior stroke or neurological disease other than TBI * has unstable or uncontrolled seizures * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months * current alcohol and/or drug use that interferes with ability to carry out common everyday functions For individuals with chronic mild TBI: Inclusion Criteria: * age 18-70 * at least 3 months post-injury * can read and speak English fluently * has a support person who is willing to participate in the study Exclusion Criteria: * has had a prior stroke or neurological disease other than mild TBI * has unstable or uncontrolled seizures * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months * current alcohol and/or drug use that interferes with ability to carry out common everyday functions For Individuals with Alzheimer's Disease Related Dementias (ADRD) Inclusion Criteria: * age 65 and older * at least one-year post-diagnosis * can read and speak English fluently * has a support person who is willing to participate in this study Exclusion Criteria: * has had a prior stroke or neurological disease other than ADRD * has unstable or uncontrolled seizures * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months * current alcohol and/or drug use that interferes with ability to carry out common everyday functions For Support Persons: Inclusion Criteria: * is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study * can read and speak English fluently Exclusion Criteria: * has a significant neurological history (e.g. stroke or multiple sclerosis) * has unstable or uncontrolled seizures * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months * current alcohol and/or drug use that interferes with ability to carry out common everyday functions

Study sites (1)

NJ