Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2023-09-01
2025-10-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CRT plus CBT and Lifestyle modifications
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).
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).
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.
Usual care
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).
Interventions
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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).
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).
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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
65 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Responsible Party
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Hala Darwish
Associate Professor of Nursing
Principal Investigators
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Hala Darwish, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00210257
Identifier Type: -
Identifier Source: org_study_id
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