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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 9 (after treatment ended)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall experience based qualitative semi-structured interview
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,854 Previous Clinical Trials
6,433,521 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
~2 spots leftby Dec 2024
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