A Pilot Randomized Controlled Trial: CoINTEGRATE
Purpose
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
Eligibility
- Eligible Ages
- Between 21 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- CRT plus CBT plus lifestyle modification or usual care
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
- Masking Description
- Only the data collectors in this study will be blind to the patient's group allocation.
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental CRT plus CBT and Lifestyle modifications |
|
|
Active Comparator Usual care |
|
Recruiting Locations
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
More Details
- NCT ID
- NCT05732285
- Status
- Recruiting
- Sponsor
- University of Michigan