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Alzheimer DiseaseNCT03384069

CBT for African Americans With Cognitive Impairment

A study testing Group-based Cognitive Behavioral Therapy (CBT) and Phone-based Cognitive Behavioral Therapy (CBT) in people with Alzheimer Disease, run by Emory University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Group-based Cognitive Behavioral Therapy (CBT) and Phone-based Cognitive Behavioral Therapy (CBT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
10 Jan 2018to 20 Nov 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Emory Clinic

    Atlanta, Georgia, 30322

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Group-based Cognitive Behavioral Therapy (CBT), Phone-based Cognitive Behavioral Therapy (CBT)
Keywords
Cognitive Impairment, Cognitive- behavioral therapy, African Americans
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group-based Cognitive Behavioral Therapy (CBT)Behavioural

    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)Behavioural

    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.

Study groups in NCT03384069
Study groupRoleWhat they receive
Group-based Cognitive Behavioral Therapy (CBT)ExperimentalThe 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.
Receives: Behavioral: Group-based Cognitive Behavioral Therapy (CBT)
Phone-based Cognitive Behavioral Therapy (CBT)ExperimentalThis 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.
Receives: Behavioral: Phone-based Cognitive Behavioral Therapy (CBT)
Standard of careNo interventionParticipants will continue to receive care and follow up from their primary care providers, that incorporates general education regarding lifestyle activities and AD prevention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants attending CBT sessions (participants retention)

    Participants retention will be estimated by number of participants attending CBT sessions.

    Measured: 3 and 6 months follow up

  2. 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.

    Measured: Baseline

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 3 and 6 months follow up

  2. 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.

    Measured: Baseline, 3 and 6 months follow up

  3. 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.

    Measured: Baseline, 3 and 6 months follow up

  4. 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.

    Measured: Baseline, 3 and 6 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2017
  2. Study start10 Jan 2018
  3. Primary completion20 Nov 2019
  4. Study completion20 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03384069
Sponsor's protocol ID
IRB00099440
Status last verified
Apr 2020
First submitted
13 Dec 2017
Last updated
29 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Group-based Cognitive Behavioral Therapy (CBT) and Phone-based Cognitive Behavioral Therapy (CBT) in people with Alzheimer Disease, run by Emory University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants attending CBT sessions (participants retention) (time frame: 3 and 6 months follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03384069.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.

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