Comprehensive Cognitive and Affective Intervention for Mild Cognitive Impairment (MCI) for Foreign-Born Arab Americans
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: CRTBehavioral: Usual care PsychoeducationBehavioral: CBTBehavioral: Modifiable lifestyle factors
- Registration Number
- NCT05854290
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRT plus CBT and Lifestyle modifications Modifiable lifestyle factors - CRT plus CBT and Lifestyle modifications CRT - CRT plus CBT and Lifestyle modifications CBT - Usual care Psychoeducation Usual care Psychoeducation -
- Primary Outcome Measures
Name Time Method Overall experience based qualitative semi-structured interview 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 week 8 (end of treatment) Average number of sessions completed week 8 (end of treatment)
- Secondary Outcome Measures
Name Time Method The Memory Complaint Scale (MCS-2 minute) score Week 9 (after treatment ended) 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)
Brief Visuospatial Memory test (BVMT-R-25 minutes) Week 9 (after treatment ended) 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.The Short Form Health Survey (SF-36) Week 9 (after treatment ended) 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) Week 9 (after treatment ended) 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
Arabic Verbal Memory Test (VMAT) Week 9 (after treatment ended) 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.
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes) Week 9 (after treatment ended) 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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States