search
Back to results

CBT for African Americans With Cognitive Impairment

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group-based Cognitive Behavioral Therapy (CBT)
Phone-based Cognitive Behavioral Therapy (CBT)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Cognitive Impairment, Cognitive- behavioral therapy, African Americans

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group-based Cognitive Behavioral Therapy (CBT)

Phone-based Cognitive Behavioral Therapy (CBT)

Standard of care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of participants attending CBT sessions (participants retention)
Participants retention will be estimated by number of participants attending CBT sessions.
Percentage of patients enrolled as per target (feasibility)
Feasibility of the six-month cognitive-behavioral therapy (CBT) program will be estimated by percentage of patients enrolled as per target.

Secondary Outcome Measures

Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)
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.
Change in the Center for Epidemiological Studies-Depression (CESD-R) score
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.
Change in Perceived Stress Scale (PSS) score
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.
Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score
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.

Full Information

First Posted
December 13, 2017
Last Updated
April 28, 2020
Sponsor
Emory University
Collaborators
Alzheimer's Association
search

1. Study Identification

Unique Protocol Identification Number
NCT03384069
Brief Title
CBT for African Americans With Cognitive Impairment
Official Title
Cognitive Behavioral Therapy for African Americans With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Cognitive Impairment, Cognitive- behavioral therapy, African Americans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-based Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Phone-based Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Participants will continue to receive care and follow up from their primary care providers, that incorporates general education regarding lifestyle activities and AD prevention.
Intervention Type
Behavioral
Intervention Name(s)
Group-based Cognitive Behavioral Therapy (CBT)
Intervention Description
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
Intervention Name(s)
Phone-based Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants attending CBT sessions (participants retention)
Description
Participants retention will be estimated by number of participants attending CBT sessions.
Time Frame
3 and 6 months follow up
Title
Percentage of patients enrolled as per target (feasibility)
Description
Feasibility of the six-month cognitive-behavioral therapy (CBT) program will be estimated by percentage of patients enrolled as per target.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)
Description
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.
Time Frame
Baseline, 3 and 6 months follow up
Title
Change in the Center for Epidemiological Studies-Depression (CESD-R) score
Description
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.
Time Frame
Baseline, 3 and 6 months follow up
Title
Change in Perceived Stress Scale (PSS) score
Description
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.
Time Frame
Baseline, 3 and 6 months follow up
Title
Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score
Description
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.
Time Frame
Baseline, 3 and 6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ambar Kulshreshtha, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CBT for African Americans With Cognitive Impairment

We'll reach out to this number within 24 hrs