NCT03384069

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable alzheimer-disease

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2019

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

December 13, 2017

Last Update Submit

April 28, 2020

Conditions

Alzheimer Disease

Keywords

Cognitive ImpairmentCognitive- behavioral therapyAfrican Americans

Outcome Measures

Primary Outcomes (2)

  • Number of participants attending CBT sessions (participants retention)

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

    3 and 6 months follow up

  • 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.

    Baseline

Secondary Outcomes (4)

  • Change in attitudes of patients regarding a CBT intervention for Mild Cognitive Impairment (MCI)

    Baseline, 3 and 6 months follow up

  • Change in the Center for Epidemiological Studies-Depression (CESD-R) score

    Baseline, 3 and 6 months follow up

  • Change in Perceived Stress Scale (PSS) score

    Baseline, 3 and 6 months follow up

  • Change in the quality of life scale (36-Item Short-Form Health Survey (SF-36)) score

    Baseline, 3 and 6 months follow up

Study Arms (3)

Group-based Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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)

Phone-based Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

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)

Standard of care

NO INTERVENTION

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

Interventions

Group-based Cognitive Behavioral Therapy (CBT)BEHAVIORAL

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.

Group-based Cognitive Behavioral Therapy (CBT)
Phone-based Cognitive Behavioral Therapy (CBT)BEHAVIORAL

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.

Phone-based Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Ambar Kulshreshtha, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asstant Professor

Study Record Dates

First Submitted

December 13, 2017

First Posted

December 27, 2017

Study Start

January 10, 2018

Primary Completion

November 20, 2019

Study Completion

November 20, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Locations

US(1)