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

NCT05854290 | Terminated

• 1 other identifier: HUM00227630
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Keywords

Caregiver; Quality of life; Cognitive Behavioral Therapy; Modifiable lifestyle factors; Cognitive Rehabilitation Therapy; Arab American

Outcome Measures

Primary Outcomes (3)

• Number of patients that complete the study

  week 8 (end of treatment)

• Average number of sessions completed

  week 8 (end of treatment)

• 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.

  Week 9 (after treatment ended)

Secondary Outcomes (6)

• The Short Form Health Survey (SF-36)

  Week 9 (after treatment ended)

• The Symbol Digit Modalities Test Score (SDMT-5 minutes)

  Week 9 (after treatment ended)

• Brief Visuospatial Memory test (BVMT-R-25 minutes)

  Week 9 (after treatment ended)

• California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)

  Week 9 (after treatment ended)

• The Memory Complaint Scale (MCS-2 minute) score

  Week 9 (after treatment ended)

Study Arms (2)

CRT plus CBT and Lifestyle modifications

EXPERIMENTAL

Behavioral: CRT; Behavioral: CBT; Behavioral: Modifiable lifestyle factors

Usual care Psychoeducation

ACTIVE COMPARATOR

Behavioral: Usual care Psychoeducation

Interventions

CRT BEHAVIORAL

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.

CRT plus CBT and Lifestyle modifications

CBT BEHAVIORAL

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.

CRT plus CBT and Lifestyle modifications

Modifiable lifestyle factors BEHAVIORAL

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.

CRT plus CBT and Lifestyle modifications

Usual care Psychoeducation BEHAVIORAL

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.

Usual care Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• \- Paid caregivers

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hala Darwish, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only the data collectors in this study will be blind to the dyad's allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing

Model Details: Caregiver and patient dyads will be randomly assigned to receive either CRT plus CBT, or usual care.

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: May 11, 2023
• Study Start: May 3, 2023
• Primary Completion: December 9, 2024
• Study Completion: December 9, 2024
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)