- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03384069
CBT for African Americans With Cognitive Impairment
April 28, 2020 updated by: Ambar Kulshreshtha, Emory University
Cognitive Behavioral Therapy for African Americans With Mild Cognitive Impairment
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).
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
|
Experimental: 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.
|
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.
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants attending CBT sessions (participants retention)
Time Frame: 3 and 6 months follow up
|
Participants retention will be estimated by number of participants attending CBT sessions.
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3 and 6 months follow up
|
Percentage of patients enrolled as per target (feasibility)
Time Frame: Baseline
|
Feasibility of the six-month cognitive-behavioral therapy (CBT) program will be estimated by percentage of patients enrolled as per target.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)
Time Frame: Baseline, 3 and 6 months follow up
|
Semi-structured interviews will be used to assess attitudes of patients.
The questions in each will be designed to examine attitudes towards the diagnosis of MCI, CBT approach for prevention, effectiveness of the intervention.
Trained staff will conduct the focus group interviews, audiotaped (with the permission of participants) and transcribed verbatim.
The ATLAS.ti software will be used to retrieve all quotations in a code category for comparison and refinement.
|
Baseline, 3 and 6 months follow up
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Change in the Center for Epidemiological Studies-Depression (CESD-R) score
Time Frame: Baseline, 3 and 6 months follow up
|
The CESD-R is a screening test for depression and depressive disorder.
The CESD-R measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode.
Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time).
Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
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Baseline, 3 and 6 months follow up
|
Change in Perceived Stress Scale (PSS) score
Time Frame: Baseline, 3 and 6 months follow up
|
The questions in the PSS ask about feelings and thoughts during the last month.
In each case, respondents are asked how often they felt a certain way.
PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all 10 scale items.
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Baseline, 3 and 6 months follow up
|
Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score
Time Frame: Baseline, 3 and 6 months follow up
|
The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section.
Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.
The lower the score the more disability.
|
Baseline, 3 and 6 months follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ambar Kulshreshtha, MD, PhD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2018
Primary Completion (Actual)
November 20, 2019
Study Completion (Actual)
November 20, 2019
Study Registration Dates
First Submitted
December 13, 2017
First Submitted That Met QC Criteria
December 22, 2017
First Posted (Actual)
December 27, 2017
Study Record Updates
Last Update Posted (Actual)
April 29, 2020
Last Update Submitted That Met QC Criteria
April 28, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00099440
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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