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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- University of Michigan
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Overall experience based qualitative semi-structured interview
- Status
- Terminated
- Last Updated
- last year
Overview
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.
Investigators
Hala Darwish
Associate Professor of Nursing
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall experience based qualitative semi-structured interview
Time Frame: Week 9 (after treatment ended)
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.
Number of patients that complete the study
Time Frame: week 8 (end of treatment)
Average number of sessions completed
Time Frame: week 8 (end of treatment)
Secondary Outcomes
- The Memory Complaint Scale (MCS-2 minute) score(Week 9 (after treatment ended))
- Brief Visuospatial Memory test (BVMT-R-25 minutes)(Week 9 (after treatment ended))
- 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))
- Arabic Verbal Memory Test (VMAT)(Week 9 (after treatment ended))
- California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)(Week 9 (after treatment ended))