A Pilot Randomized Controlled Trial: CoINTEGRATE

Launched by UNIVERSITY OF MICHIGAN · Feb 7, 2023

Keywords

ClinConnect Summary

The CoINTEGRATE trial is a research study aimed at exploring a new approach to help individuals with neurocognitive disorders, such as traumatic brain injury, multiple sclerosis, and mild cognitive impairment. The study will look at whether a combination of tailored therapies—like Cognitive Behavioral Therapy (CBT) and Cognitive Rehabilitation Therapy (CRT)—along with lifestyle changes, can improve participants' community integration and overall quality of life compared to standard care. The researchers believe that these combined methods could be beneficial for patients.

To participate in this study, individuals must be diagnosed with specific conditions like mild traumatic brain injury, multiple sclerosis, long COVID, or mild cognitive impairment. They should be between the ages of 21 to 65, or over 50 for mild cognitive impairment, and receiving care through the Michigan medicine network. Participants will need to be able to provide consent or have a representative who can do so for them. Those who join the study can expect to engage in various therapy sessions tailored to their needs. It's important to note that individuals with certain health issues, such as severe depression or specific medical conditions, may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosed with one of the following: Mild Trauma Brain injury (TBI), Multiple Sclerosis (MS), Long COVID, or Mild Cognitive Impairment (MCI)
• • MCI patients age older than 50 years old, all other diagnosis 21-65 years old and are receiving care through the Michigan medicine network
• • Participants that can provide consent or legally authorized representative who can provide consent on their behalf
• • Cognitive impairment ≥ 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
• Exclusion Criteria:
• • TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
• • History of TBI (except for participants with TBI)
• • MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
• • MCI participants with disease duration greater than 1 year
• • Patients with other neurosensory or neurodegenerative diseases
• • Diagnosed with COVID-19 (except for Long COVID group)
• • Psychiatric disorders other than mild to moderate anxiety and depression
• • Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources and referred to patient's primary care provider
• • Diagnosed sleep disorders
• • Visual or auditory impairment,
• • Current or history of alcohol or substance abuse/dependence
• • Cognitive impairment less than 1.0 standard deviation below the test score normed for age and education in at least 2 cognitive domains (verbal learning and memory, processing speed, or visuospatial memory)
• • Cognitive impairment greater or equal to 1.0 standard deviation below the test score normed for age and education in 1 cognitive domain (verbal learning and memory, processing speed, or visuospatial memory)
• • Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy