A Pilot Randomized Controlled Trial: CoINTEGRATE

Description

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study 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.

A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)

A Pilot Randomized Controlled Trial: CoINTEGRATE

Condition
Neurocognitive Disorders
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Hala Darwish, PhD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2025-12-30