Clinical trial NCT03384069: CBT for African Americans With Cognitive Impairment
Official title: Cognitive Behavioral Therapy for African Americans With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Cognitive Impairment
Cognitive- behavioral therapy
African Americans
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2017-12-27
Enrollment: 31
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants attending CBT sessions (participants retention)
timeFrame: 3 and 6 months follow up
measure: Percentage of patients enrolled as per target (feasibility)
timeFrame: Baseline
Secondary outcomes:
measure: Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)
timeFrame: Baseline, 3 and 6 months follow up
measure: Change in the Center for Epidemiological Studies-Depression (CESD-R) score
timeFrame: Baseline, 3 and 6 months follow up
measure: Change in Perceived Stress Scale (PSS) score
timeFrame: Baseline, 3 and 6 months follow up
measure: Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score
timeFrame: Baseline, 3 and 6 months follow up
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Ambar Kulshreshtha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: