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A Pilot Randomized Controlled Trial: CoINTEGRATE

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

NCT05732285•University of Michigan

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

21 - 65 years

Sex

ALL

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,
+4 more criteria

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Key Dates

Start Date

September 1, 2023

Primary Completion Date

September 1, 2025

Completion Date

October 1, 2025

Last Updated

October 20, 2025

Enrollment

ACTUAL participants

Conditions

Neurocognitive DisordersCognitive DysfunctionTraumatic Brain InjuryMultiple SclerosisMild Cognitive Impairment

Interventions

CRT

BEHAVIORAL

CBT

BEHAVIORAL

Modifiable lifestyle factors

BEHAVIORAL

Usual care Psychoeducation

BEHAVIORAL

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

NCT04521881

Traumatic Brain Injury

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RECRUITINGPHASE3

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

NCT05508789

Alzheimer DiseaseDementia+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Randomized Controlled Trial: CoINTEGRATE

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

Cognitive Remediation