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Comprehensive Cognitive + Affective Intervention for Mild Cognitive Impairment (CoINTEGRATE Trial)

N/A
Recruiting
Led By Hala Darwish, PhD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Persons with MCI: 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)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9 (after treatment ended)
Awards & highlights

CoINTEGRATE Trial Summary

This trial will evaluate the efficacy of combining cognitive and affective therapies with lifestyle modifications in improving cognitive performance and Quality of Life (QoL) in Arab American MCI patients and their caregivers. #MCI #CBT #CRT #QoL

Who is the study for?
This trial is for foreign-born Arab Americans over 60 with Mild Cognitive Impairment (MCI) or a Montreal Cognitive Assessment score of 25 or less. Participants must have had MCI for no more than three years, be fluent in Arabic or English, and have cognitive impairment in at least two domains. They need to consent themselves or through a representative and identify a caregiver who can assist them.Check my eligibility
What is being tested?
The study tests if combining Cognitive Behavioral Therapy (CBT), Cognitive Rehabilitation Therapy (CRT), and lifestyle changes improves cognitive function and quality of life in MCI patients compared to usual care. It involves the patient-caregiver dyads to see if this approach is feasible.See study design
What are the potential side effects?
Since the interventions are non-pharmaceutical, side effects may include discomfort from therapy sessions, potential stress from lifestyle changes, and emotional responses during CBT.

CoINTEGRATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have mild cognitive impairment with significant memory or thinking speed issues.

CoINTEGRATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 9 (after treatment ended)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 9 (after treatment ended) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average number of sessions completed
Number of patients that complete the study
Overall experience based qualitative semi-structured interview
Secondary outcome measures
Arabic Verbal Memory Test (VMAT)
Brief Visuospatial Memory test (BVMT-R-25 minutes)
California Verbal Learning Test-Third Edition (CVLT-3-60 minutes)
+3 more

CoINTEGRATE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CRT plus CBT and Lifestyle modificationsExperimental Treatment3 Interventions
Group II: Usual care PsychoeducationActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CRT
2008
Completed Phase 4
~860
CBT
2013
Completed Phase 3
~4220

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,786 Previous Clinical Trials
6,365,082 Total Patients Enrolled
Hala Darwish, PhDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
56 Total Patients Enrolled

Media Library

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT05854290 — N/A
Mild Cognitive Impairment Research Study Groups: CRT plus CBT and Lifestyle modifications, Usual care Psychoeducation
Mild Cognitive Impairment Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT05854290 — N/A
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05854290 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any further slots available for this experiment?

"Affirmative. According to clinicaltrials.gov, this medical test is actively recruiting participants since it was initially posted on May 3rd 2023 and edited most recently on May 2nd of the same year. The trial requires 40 patients from a single site for completion."

Answered by AI

How many people have volunteered to participate in this clinical experiment?

"Affirmative. Data hosted on clinicaltrials.gov verifies that this scientific study, which was first posted on May 3rd 2023, is currently seeking participants for recruitment. Approximately 40 people must be enrolled from 1 particular medical centre."

Answered by AI

What are the projected results of this medical experiment?

"The primary goal of this research is to calculate the average number of sessions completed during week 8. Secondary objectives include assessing divided attention, visual scanning, tracking and motor speed using the Symbol Digit Modalities Test (SDMT-5 minutes), measuring verbal learning and memory deficits through California Verbal Learning Test-Third Edition (CVLT-3-60 minutes), and gauging visuospatial memory with Brief Visuospatial Memory test (BVMT-R-25 minutes). Each trial yields a score from 0 to 16 for CVLT or 0 to 12 for SDT/BVTM; higher scores indicate better memories."

Answered by AI
~0 spots leftby Apr 2024