Combining therapies to improve cognitive function and quality of life in patients with neurocognitive disorders
A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)
This study is testing if a mix of therapy and lifestyle changes can help improve thinking skills and quality of life for people with neurocognitive disorders like Mild Traumatic Brain Injury and Multiple Sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 21 Years to 65 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT05732285 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of a comprehensive, multimodal approach that includes Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and lifestyle modifications for patients with neurocognitive disorders. The study hypothesizes that this combination will enhance community integration and quality of life compared to standard care. Participants will be individuals diagnosed with conditions such as Mild Traumatic Brain Injury, Multiple Sclerosis, Long COVID, or Mild Cognitive Impairment, who will receive tailored interventions based on their specific needs. The study will take place at the University of Michigan and will involve patients receiving care through their network.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 21-65 with Mild Traumatic Brain Injury, Multiple Sclerosis, Long COVID, or Mild Cognitive Impairment, and those over 50 with Mild Cognitive Impairment.
Not a fit: Patients with symptomatic TBI at rest, recent MS relapses, or those with Mild Cognitive Impairment lasting longer than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive function and overall quality of life for patients with neurocognitive disorders.
How similar studies have performed: Other studies have shown promise in using combined cognitive and lifestyle interventions for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Hala Darwish, PhD — University of Michigan
- Study coordinator: Zee Petrie
- Email: petrieli@med.umich.edu
- Phone: 734-647-3357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.