NCT05732285Completed
A Pilot Randomized Controlled Trial: CoINTEGRATE
A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)
Source: ClinicalTrials.gov · Last updated 20 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 7 Feb 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Sept 2025
- Lead sponsor
- University of Michigan
- Diseases
- Long COVID and ME/CFS, Multiple sclerosis
- NCT number
- NCT05732285
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 1 Sept 2023 to the primary completion date, 1 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MS participants with recent relapse (1 month prior to enrollment) or on Intravenous or oral steroids
- Currently receiving CRT, CBT or Occupational therapy (OT) or another type of psychological therapy
Other illness
- History of TBI (except for participants with TBI)
- 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
- Diagnosed sleep disorders
- Visual or auditory impairment,
- Current or history of alcohol or substance abuse/dependence
Age
- 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)
Other
- TBI participants symptomatic at rest (headache, dizziness, nausea, or vertigo) will be referred to primary care physician (PCP)
- 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
Who the study is looking for
- 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)
Age in the registry: 21 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.