Clinical trial NCT05854290: Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans
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
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Caregiver
Quality of life
Cognitive Behavioral Therapy
Modifiable lifestyle factors
Cognitive Rehabilitation Therapy
Arab American
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregiver and patient dyads will be randomly assigned to receive either CRT plus CBT, or usual care.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of patients that complete the study
timeFrame: week 8 (end of treatment)
measure: Average number of sessions completed
timeFrame: week 8 (end of treatment)
measure: Overall experience based qualitative semi-structured interview
timeFrame: Week 9 (after treatment ended)
Secondary outcomes:
measure: The Short Form Health Survey (SF-36)
timeFrame: Week 9 (after treatment ended)
measure: The Symbol Digit Modalities Test Score (SDMT-5 minutes)
timeFrame: Week 9 (after treatment ended)
measure: Brief Visuospatial Memory test (BVMT-R-25 minutes)
timeFrame: Week 9 (after treatment ended)
measure: California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
timeFrame: Week 9 (after treatment ended)
measure: The Memory Complaint Scale (MCS-2 minute) score
timeFrame: Week 9 (after treatment ended)
measure: Arabic Verbal Memory Test (VMAT)
timeFrame: Week 9 (after treatment ended)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hala Darwish, PhD
role: PRINCIPAL_INVESTIGATOR
References: