CBT for African Americans With Cognitive Impairment

NCT ID: NCT03384069

Last Updated: 2020-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2019-11-20

Brief Summary

The aim of the study is to test the feasibility and acceptability of a six-month cognitive-behavioral therapy (CBT) program (group based and phone-based) compared with usual care, and to determine if the intervention can improve cognitive performance and reduce chronic stress in a randomized trial including 30 African American patients with Mild Cognitive Impairment (MCI). The CBT program among African Americans with MCI will provide preliminary evidence about the efficacy and the optimal intensity of the intervention needed for patients at risk of Alzheimer's disease (AD).

Detailed Description

Mild Cognitive Impairment (MCI) can involve problems with memory, language, thinking and judgment that are greater than normal age-related changes and it maybe a precursor for Alzheimer's disease. African Americans have a higher risk of developing MCI compared with Whites. Unfortunately, prevention and management of MCI has been understudied among African-Americans. Chronic stress (such as perceived discrimination, daily environmental stress) in African Americans can affect cognition and also plays a role in worsening of unhealthy behaviors such as smoking, improper diet and physical inactivity. Cognitive-behavioral therapy (CBT) is a collaborative psychological approach that addresses the interaction between people's thoughts, feelings and behavior. Existing evidence suggests that CBT can be an effective strategy for dementia patients with co-morbid anxiety. However, none of these studies have specifically evaluated African Americans with MCI. The aim of the study is to test the feasibility and acceptability of a six-month CBT program (group based and phone-based) compared with usual care, and to determine if the intervention can improve cognitive performance and reduce chronic stress in a randomized trial including 30 African American patients with MCI. The CBT program among African Americans with MCI will provide preliminary evidence about the efficacy and the optimal intensity of the intervention needed for patients at risk of Alzheimer's disease.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group-based Cognitive Behavioral Therapy (CBT)

The Group-based CBT will incorporate psycho-education about cognitive behavioral skills and written materials to support learning and application of the psycho-educational content. The intervention will be culturally tailored to incorporate beliefs/attitudes, health literacy, effective communication, and motivational strategies, which focus on African Americans.

Group Type: EXPERIMENTAL

Group-based Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

The group-based CBT intervention will include twelve 1-hour group sessions held biweekly for six months. Each sixty-minute session will consist of 15 minutes of Alzheimer's disease (AD) prevention education and approximately 45 minutes of CBT presentations/engagement activities. A physician and a Behavioral Interventionist will collaboratively facilitate the group sessions.

Phone-based Cognitive Behavioral Therapy (CBT)

This intervention will follow the same protocol as the group-based CBT, but without the opportunity for group-interaction. It will incorporate psycho-education about cognitive behavioral skills and written materials to support learning and application of the psycho-educational content. The intervention will be culturally tailored to incorporate beliefs/attitudes, health literacy, effective communication, and motivational strategies, which focus on African Americans.

Group Type: EXPERIMENTAL

Phone-based Cognitive Behavioral Therapy (CBT)

Intervention Type: BEHAVIORAL

Participants in the phone-based CBT will be asked to reserve a 1-hour period for a phone call from the Behavioral Interventionist biweekly for six months. Text reminders will be sent to the participant's prior the sessions. This intervention will follow the same frequency and format as the group-based CBT and will use an established protocol incorporating the same elements of cognitive behavior change as in the group-based CBT, but without the opportunity for group-interaction.

Standard of care

Participants will continue to receive care and follow up from their primary care providers, that incorporates general education regarding lifestyle activities and AD prevention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Group-based Cognitive Behavioral Therapy (CBT)

The group-based CBT intervention will include twelve 1-hour group sessions held biweekly for six months. Each sixty-minute session will consist of 15 minutes of Alzheimer's disease (AD) prevention education and approximately 45 minutes of CBT presentations/engagement activities. A physician and a Behavioral Interventionist will collaboratively facilitate the group sessions.

Intervention Type: BEHAVIORAL

Phone-based Cognitive Behavioral Therapy (CBT)

Participants in the phone-based CBT will be asked to reserve a 1-hour period for a phone call from the Behavioral Interventionist biweekly for six months. Text reminders will be sent to the participant's prior the sessions. This intervention will follow the same frequency and format as the group-based CBT and will use an established protocol incorporating the same elements of cognitive behavior change as in the group-based CBT, but without the opportunity for group-interaction.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age: 50 years or older
• Race: African American
• Fluency in English
• Mild Cognitive Impairment (MCI) - defined as subjective memory complaints with a Montreal Cognitive Assessment (MoCA) 18- 26

Exclusion Criteria

• Dementia diagnosis or reversible causes of dementia (e.g. if the patient has hypothyroidism or low vitamin B12 that is contributing to the subject's cognitive impairment)
• Active medical or psychiatric diseases that in the judgment of the investigator would affect the safety of the subject or scientific integrity of the study (e.g. actively manic patient)
• Uncontrolled medical conditions (such as congestive heart failure) reflected by poor exercise tolerance and shortness of breath
• Any physical ailment (such as stroke with residual impairment) that is a barrier to perform study procedures and attend sessions.
• Those who are unable to demonstrate that they understood the details of the study (i.e. lack of decisional- capacity to consent) or linguistic limitations will be excluded;
• Pregnant women
• Prisoners
• Adults unable to consent

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alzheimer's Association

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Ambar Kulshreshtha

Asstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ambar Kulshreshtha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory Clinic

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00099440

Identifier Type: -

Identifier Source: org_study_id