Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans (CoINTEGRATE)

University of Michigan

Status: Terminated

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: CRT; Behavioral: Usual care Psychoeducation; Behavioral: Modifiable lifestyle factors; Behavioral: CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT05854290

HUM00227630

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

CRT plus CBT and Lifestyle modifications

Experimental group

Treatment:

Behavioral: CBT

Behavioral: Modifiable lifestyle factors

Behavioral: CRT

Usual care Psychoeducation

Active Comparator group

Treatment:

Behavioral: Usual care Psychoeducation