Comprehensive Cognitive + Affective Intervention for Mild Cognitive Impairment

(CoINTEGRATE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Hala Darwish, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Michigan

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Persons with MCI: Foreign-Born Arab origins, Language: Arabic or English

My mild cognitive impairment has been diagnosed within the last 3 years.

Caretakers: Above the age of 18 years Fluent in Arabic and/or English

Exclusion Criteria

I have been diagnosed with Covid-19.

I am under 60 years old with mild cognitive impairment.

I have mild cognitive impairment but do not have severe depression or suicidal thoughts.

Participant Groups

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.

Group I: CRT plus CBT and Lifestyle modifications Experimental Treatment 3 Interventions

Group II: Usual care Psychoeducation Active Control 1 Intervention

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

🇪🇺 Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

🇨🇦 Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan Ann Arbor, MI

Who Is Running the Clinical Trial?

University of Michigan Lead Sponsor

References