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A Pilot Randomized Controlled Trial: CoINTEGRATE

Recruiting
21 - 65 years of age
Both
Phase N/A

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Overview

The purpose of this study is to examine the feasibility of comprehensive multimodal individually tailored Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle sessions.

The study team hypothesizes that combining evidence-based cognitive and affective therapies with lifestyle modifications is feasible and will improve the community integration (CI) and Quality of life (QoL) in patients with a neurocognitive disorder compared to usual care.

Eligibility

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

Study details

Neurocognitive Disorders, Cognitive Dysfunction, Traumatic Brain Injury, Multiple Sclerosis, Mild Cognitive Impairment

NCT05732285

University of Michigan

27 January 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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