A Pilot Randomized Controlled Trial: CoINTEGRATE
A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)
We could not find results for this trial
What it found
We found no results in the registry or in papers.
This trial finished 14 months ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- CRT
- CBT
- Modifiable lifestyle factors
Compared with
- Usual care Psychoeducation
What it measured
Main measures
Number of patients that complete the study
week 8 (end of treatment)
Average number of sessions completed
week 8 (end of treatment)
Overall experience based qualitative semi-structured interview
Week 9 (after treatment ended)
Quality of life (reported by participants)
Other measures (7)
The Community Integration Questionnaire (CIQ) Score
Week 9 (after treatment ended)
The Short Form Health Survey (SF-36)
Week 9 (after treatment ended)
Quality of life (reported by participants)Montreal Cognitive Assessment (MoCA)
Week 9 (after treatment ended)
Thinking and memoryThe Symbol Digit Modalities Test Score (SDMT-5 minutes)
Week 9 (after treatment ended)
Thinking and memoryBrief Visuospatial Memory test (BVMT-R-25 minutes)
Week 9 (after treatment ended)
Thinking and memoryCalifornia Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
Week 9 (after treatment ended)
Thinking and memoryThe Memory Complaint Scale (MCS-2 minute) score
Week 9 (after treatment ended)
Thinking and memory
Who could take part
MS (type not specified) · 21 to 65
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Sept 2023
Main results due
Sept 2025
Finished
Oct 2025