A Pilot Randomized Controlled Trial: CoINTEGRATE

University of Michigan

Status

Completed

Conditions

Traumatic Brain Injury

Mild Cognitive Impairment

Multiple Sclerosis

Cognitive Dysfunction

Neurocognitive Disorders

Treatments

Behavioral: CBT

Behavioral: CRT

Behavioral: Usual care Psychoeducation

Behavioral: Modifiable lifestyle factors

Study type

Interventional

Funder types

Other

Identifiers

NCT05732285

HUM00210257

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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