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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
CRT plus CBT plus lifestyle modification or usual care
Primary Purpose
Treatment
Masking
Single (Care Provider)
Masking Description
Only the data collectors in this study will be blind to the patient's group allocation.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CRT plus CBT and Lifestyle modifications
  • Behavioral: CRT
    Participants that score 1-1.5 standard deviation (SD) below the norm for age and education on 2 cognitive domains will receive an intensive program, 2 CRT sessions per week for 4 weeks in addition to 1 CBT session per week for 8 weeks. Based on clinical experience, those with more severe cognitive deficits require more time to achieve their therapy goals, whereas those with mild deficits can tolerate a more intense therapy. Participants that score 1.5-2 SD or more below the norm for age and education on 2 cognitive domains will receive 1 CRT and 1 CBT weekly sessions for 8 weeks. All the CRT sessions will be coupled with homework for 8 weeks. All research-related sessions will be web-based (on Zoom) and recorded (with approval).
  • Behavioral: CBT
    Participants that score 1-1.5 standard deviation (SD) below the norm for age and education on 2 cognitive domains will receive an intensive program, 2 CRT sessions per week for 4 weeks in addition to 1 CBT session per week for 8 weeks. Based on clinical experience, those with more severe cognitive deficits require more time to achieve their therapy goals, whereas those with mild deficits can tolerate a more intense therapy. Participants that score 1.5-2 SD or more below the norm for age and education on 2 cognitive domains will receive 1 CRT and 1 CBT weekly sessions for 8 weeks. All the CRT sessions will be coupled with homework for 8 weeks. All research-related sessions will be web-based (on Zoom) and recorded (with approval).
  • Behavioral: Modifiable lifestyle factors
    The therapy sessions are coupled with homework and requires some lifestyle modifications such lifestyle adjustments are using a calendar, a diary, maintaining a sleep schedule and exercise.
Active Comparator
Usual care
  • Behavioral: Usual care Psychoeducation
    Participants will receive 15 minute psychoeducation session twice per week for 8 weeks. All research-related sessions will be web-based (on Zoom) and recorded (with approval).

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Zee Petrie
734-647-3357
petrieli@med.umich.edu

More Details

NCT ID
NCT05732285
Status
Recruiting
Sponsor
University of Michigan

Study Contact

Zee Petrie
734-647-3357
petrieli@med.umich.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.