CBT for African Americans With Cognitive Impairment
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|ClinicalTrials.gov Identifier: NCT03384069|
Recruitment Status : Completed
First Posted : December 27, 2017
Last Update Posted : April 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Behavioral: Group-based Cognitive Behavioral Therapy (CBT) Behavioral: Phone-based Cognitive Behavioral Therapy (CBT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cognitive Behavioral Therapy for African Americans With Mild Cognitive Impairment|
|Actual Study Start Date :||January 10, 2018|
|Actual Primary Completion Date :||November 20, 2019|
|Actual Study Completion Date :||November 20, 2019|
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.
Behavioral: 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.
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.
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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03384069
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Ambar Kulshreshtha, MD, PhD||Emory University|