Back to resultsComprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) For Foreign-Born Arab Americans (CoINTEGRATE)
Primary Purpose
Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CRT
CBT
Modifiable lifestyle factors
Usual care Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Caregiver, Quality of life, Cognitive Behavioral Therapy, Modifiable lifestyle factors, Cognitive Rehabilitation Therapy, Arab American
Eligibility Criteria
Inclusion Criteria for Persons with MCI: All patients diagnosed with MCI or Persons with Montreal Cognitive Assessment (MoCA) less or equal to 25 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 Inclusion Criteria for Caretakers: 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 Persons with MCI: History of traumatic brain injury (TBI) 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 Exclusion Criteria for Caretakers: - Paid caregivers
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CRT plus CBT and Lifestyle modifications
Usual care Psychoeducation
Arm Description
Outcomes
Primary Outcome Measures
Number of patients that complete the study
Average number of sessions completed
Overall experience based qualitative semi-structured interview
This interview will be conducted at the end of the study and in the order of exit of participants to gather feedback about their satisfaction with the study. This brief interview consists of 3 questions that ask the participants to describe the aspects of the intervention participants found beneficial, willingness to participate again, and whether it was appropriate for participants needs. In addition, a brief quantitative satisfaction survey to rate overall satisfaction, how likely it would be recommend to others, and how satisfied participants are with telemedicine as a mode of delivery.
Secondary Outcome Measures
The Short Form Health Survey (SF-36)
The SF-36 explores people's physical and mental health. It consists of 36 items that assess role limitations due to personal or emotional problems, emotional well-being, social functioning, general health perceptions, perceived change in health. Scores ranged from 0 (worst health status) to 100 (best health status).
The Symbol Digit Modalities Test Score (SDMT-5 minutes)
The Symbol Digit Modalities Test (SDMT) is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively culture free as well and can be administered to individuals who do not speak English. It takes approximately 5 minutes to complete the entire test. Scoring involves summing the number of correct substitutions within the 90 second interval the max score is 110, where a higher score indicates a better memory
Brief Visuospatial Memory test (BVMT-R-25 minutes)
This test is comprised of three memory trials (10 seconds each) followed by delayed recall after 25 minutes and a recognition trial. It has been widely used as a quick measure of visuospatial memory. The digital stimulus forms will be used (alternate form will be used at the end of the study to control for practice effect).
Recall performance will record for each of the immediate recall trials (Trial 1, Trial 2, and Trial 3) and for the delayed recall trial (Delayed Recall). The study team will combine the recall scores to form three additional summary measures of learning and memory. Recognition Hits and False Alarms will be recorded during the delayed recognition task. Recognition Hits are calculated as the number of correct responses to target items, and Recognition False Alarms are calculated as the number of incorrect responses to nontarget items. Each trial is worth 0-12 points, so the total score is 0-36, a higher score indicates a better memory.
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
The California Verbal Learning Test, Third Edition (CVLT-3) measures both recall and recognition of two lists of words (List A and List B) over a number of immediate and delayed memory trials. It provides an assessment of verbal learning and memory deficits in adults ages 16 - 90. Score of 0-16, where a lower score indicates worse memory, and a high score indicates better memory.
The Memory Complaint Scale (MCS-2 minute) score
The Memory Complaint Scale (MCS-2 min) is comprised of 14 items and is designed for subjective memory complaints.The test yields a total score with a classification in terms of memory complaint (MC) based on their score as follows: No MC (0-2), mild MC (3-6), moderate MC (7-10) or severe MC (11-14)
Arabic Verbal Memory Test (VMAT)
The Arabic Verbal Memory Test is a verbal memory test that consists of 3 lists (List A, List B (each 15 words), and a Recognition List (45 words). It assesses verbal learning and memory in adults aged 16-90. The scores will include scores on learning trials 1-5, free and cued short recall, interference trial free recall and delayed free and cued recall, yes/ no recognition, and forced choice recognition. The test yields a score of 0-15, where a lower score indicates worse memory and a high score indicates better memory.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05854290
Brief Title
Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) For Foreign-Born Arab Americans
Acronym
CoINTEGRATE
Official Title
A Pilot Randomized Controlled Trial of A Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) (CoINTEGRATE- For Foreign-Born Arab Americans- a Dyadic Approach)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this pilot study is to evaluate the feasibility of a cognitive and affective intervention for foreign born Arab American dyads consisting of the person with Mild Cognitive Impairment (MCI) and participants caregiver. This study will evaluate the feasibility of a cognitive and affective intervention combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and modifiable lifestyle factors to address the cognitive and affective dysfunctions associated with Mild Cognitive Impairment (MCI) or those with cognitive complaints.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Caregiver, Quality of life, Cognitive Behavioral Therapy, Modifiable lifestyle factors, Cognitive Rehabilitation Therapy, Arab American
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Caregiver and patient dyads will be randomly assigned to receive either CRT plus CBT, or usual care.
Masking
Outcomes Assessor
Masking Description
Only the data collectors in this study will be blind to the dyad's allocation.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CRT plus CBT and Lifestyle modifications
Arm Type
Experimental
Arm Title
Usual care Psychoeducation
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CRT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Modifiable lifestyle factors
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care Psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients that complete the study
Time Frame
week 8 (end of treatment)
Title
Average number of sessions completed
Time Frame
week 8 (end of treatment)
Title
Overall experience based qualitative semi-structured interview
Description
This interview will be conducted at the end of the study and in the order of exit of participants to gather feedback about their satisfaction with the study. This brief interview consists of 3 questions that ask the participants to describe the aspects of the intervention participants found beneficial, willingness to participate again, and whether it was appropriate for participants needs. In addition, a brief quantitative satisfaction survey to rate overall satisfaction, how likely it would be recommend to others, and how satisfied participants are with telemedicine as a mode of delivery.
Time Frame
Week 9 (after treatment ended)
Secondary Outcome Measure Information:
Title
The Short Form Health Survey (SF-36)
Description
The SF-36 explores people's physical and mental health. It consists of 36 items that assess role limitations due to personal or emotional problems, emotional well-being, social functioning, general health perceptions, perceived change in health. Scores ranged from 0 (worst health status) to 100 (best health status).
Time Frame
Week 9 (after treatment ended)
Title
The Symbol Digit Modalities Test Score (SDMT-5 minutes)
Description
The Symbol Digit Modalities Test (SDMT) is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively culture free as well and can be administered to individuals who do not speak English. It takes approximately 5 minutes to complete the entire test. Scoring involves summing the number of correct substitutions within the 90 second interval the max score is 110, where a higher score indicates a better memory
Time Frame
Week 9 (after treatment ended)
Title
Brief Visuospatial Memory test (BVMT-R-25 minutes)
Description
This test is comprised of three memory trials (10 seconds each) followed by delayed recall after 25 minutes and a recognition trial. It has been widely used as a quick measure of visuospatial memory. The digital stimulus forms will be used (alternate form will be used at the end of the study to control for practice effect).
Recall performance will record for each of the immediate recall trials (Trial 1, Trial 2, and Trial 3) and for the delayed recall trial (Delayed Recall). The study team will combine the recall scores to form three additional summary measures of learning and memory. Recognition Hits and False Alarms will be recorded during the delayed recognition task. Recognition Hits are calculated as the number of correct responses to target items, and Recognition False Alarms are calculated as the number of incorrect responses to nontarget items. Each trial is worth 0-12 points, so the total score is 0-36, a higher score indicates a better memory.
Time Frame
Week 9 (after treatment ended)
Title
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
Description
The California Verbal Learning Test, Third Edition (CVLT-3) measures both recall and recognition of two lists of words (List A and List B) over a number of immediate and delayed memory trials. It provides an assessment of verbal learning and memory deficits in adults ages 16 - 90. Score of 0-16, where a lower score indicates worse memory, and a high score indicates better memory.
Time Frame
Week 9 (after treatment ended)
Title
The Memory Complaint Scale (MCS-2 minute) score
Description
The Memory Complaint Scale (MCS-2 min) is comprised of 14 items and is designed for subjective memory complaints.The test yields a total score with a classification in terms of memory complaint (MC) based on their score as follows: No MC (0-2), mild MC (3-6), moderate MC (7-10) or severe MC (11-14)
Time Frame
Week 9 (after treatment ended)
Title
Arabic Verbal Memory Test (VMAT)
Description
The Arabic Verbal Memory Test is a verbal memory test that consists of 3 lists (List A, List B (each 15 words), and a Recognition List (45 words). It assesses verbal learning and memory in adults aged 16-90. The scores will include scores on learning trials 1-5, free and cued short recall, interference trial free recall and delayed free and cued recall, yes/ no recognition, and forced choice recognition. The test yields a score of 0-15, where a lower score indicates worse memory and a high score indicates better memory.
Time Frame
Week 9 (after treatment ended)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria for Persons with MCI:
All patients diagnosed with MCI or Persons with Montreal Cognitive Assessment (MoCA) less or equal to 25
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
Inclusion Criteria for Caretakers:
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 Persons with MCI:
History of traumatic brain injury (TBI)
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
Exclusion Criteria for Caretakers:
- Paid caregivers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zee Petrie
Phone
734-647-3357
Email
petrieli@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Hala Darwish, PhD
Phone
734-647-4929
Email
darwishh@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Darwish, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zee Petrie
Phone
734-647-3357
Email
petrieli@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Hala Darwish, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) For Foreign-Born Arab Americans
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