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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• 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)

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Zee Petrie
petrieli@med.umich.edu
734-647-3357
Backup
Hala Darwish, PhD
darwishh@med.umich.edu
734-647-4929
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 56
Treatments
Experimental: CRT plus CBT and Lifestyle modifications
Active_comparator: Usual care
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov