Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans
NCT ID: NCT05854290
Last Updated: 2024-12-13
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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TERMINATED
NA
1 participants
INTERVENTIONAL
2023-05-03
2024-12-09
Brief Summary
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The study team hypothesizes that combining evidence-based cognitive and affective therapies (CRT+CBT) with lifestyle modifications is feasible and will improve the cognitive performance and Quality of Life (QoL) in patients with MCI and participants caregivers compared to usual care.
Detailed Description
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Conditions
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Keywords
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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 will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
CBT
Participants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
Modifiable lifestyle factors
The therapy sessions are coupled with homework and requires some lifestyle modifications for the persons with MCI, such lifestyle adjustments are using a calendar, a diary, maintaining a sleep schedule and exercise.
Usual care Psychoeducation
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).
Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
Interventions
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CRT
Participants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
CBT
Participants will complete an 8-week intervention, 2 sessions per week. Co-INTEGRATE sessions take 30-50 minutes to complete. Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
Modifiable lifestyle factors
The therapy sessions are coupled with homework and requires some lifestyle modifications for the persons with MCI, 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).
Weekly on the day of the last therapy session, before or after the session, all patients, regardless of the group assigned to, will be asked to complete an electronic brief questionnaire to provide information, on sleep, recreational habits, alcohol intake, exercise, and smoking.
Eligibility Criteria
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Inclusion Criteria
* Disease duration less or equal to 3 years
* Age older than 60 years
* Foreign-Born Arab origins, Language: Arabic or English
* 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)
* Participants who can provide consent or legally authorized representative who can provide consent on their behalf
* Identified by the patients as the person that provides the most care for them with regards to medical care; may be a spouse, an adult child, a sibling, a relative, or family friend
* Above the age of 18 years Fluent in Arabic and/or English
* Can complete a self-report questionnaire by interview or self-report.
Exclusion Criteria
* Diagnosed with Covid-19
* Patients with other neurosensory or neurodegenerative diseases
* Younger than 60 years
* Psychiatric disorders other than mild to moderate anxiety and depression
* Diagnosed sleep disorders
* Visual or auditory impairment
* Current or history of alcohol or substance abuse/dependence
* Patients with severe depression or suicidal (ideation or plan) will be instructed to seek mental health, provided with resources, and referred to their primary care provider
\- Paid caregivers
18 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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HUM00227630
Identifier Type: -
Identifier Source: org_study_id