Clinical trial NCT05732285: A Pilot Randomized Controlled Trial: CoINTEGRATE
Official title: A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Neurocognitive Disorders (CoINTEGRATE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurocognitive Disorders
Cognitive Dysfunction
Traumatic Brain Injury
Multiple Sclerosis
Mild Cognitive Impairment
Keywords: Affective Dysfunction
Cognitive Behavioral Therapy
Modifiable lifestyle factors
Cognitive Rehabilitation Therapy
Long COVID (coronavirus disease)
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: CRT plus CBT plus lifestyle modification or usual care
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of patients that complete the study
timeFrame: week 8 (end of treatment)
measure: Average number of sessions completed
timeFrame: week 8 (end of treatment)
measure: Overall experience based qualitative semi-structured interview
timeFrame: Week 9 (after treatment ended)
Secondary outcomes:
measure: The Community Integration Questionnaire (CIQ) Score
timeFrame: Week 9 (after treatment ended)
measure: The Short Form Health Survey (SF-36)
timeFrame: Week 9 (after treatment ended)
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Week 9 (after treatment ended)
measure: The Symbol Digit Modalities Test Score (SDMT-5 minutes)
timeFrame: Week 9 (after treatment ended)
measure: Brief Visuospatial Memory test (BVMT-R-25 minutes)
timeFrame: Week 9 (after treatment ended)
measure: California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
timeFrame: Week 9 (after treatment ended)
measure: The Memory Complaint Scale (MCS-2 minute) score
timeFrame: Week 9 (after treatment ended)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hala Darwish, PhD
role: PRINCIPAL_INVESTIGATOR
References: