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Preventing Cognitive Decline in African Americans With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT01299766
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : November 20, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
Dartmouth College
Johns Hopkins University
University of Pennsylvania
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition Mild Cognitive Impairment (MCI)
Interventions Behavioral: Behavioral Activation (BA)
Behavioral: Supportive Therapy (ST)
Enrollment 221
Recruitment Details Enrollment from June 21, 2011 to October 3, 2014; follow-up ended December 13, 2016. Potential participants were recruited when they sought memory screening at senior centers, senior housing sites, churches, and primary care clinics in Philadelphia, PA.
Pre-assignment Details Prior to randomization, participants were administered neuropsychological tests to determine whether they met criteria for MCI. Participants with normal cognition and those with suspected dementia were excluded.
Arm/Group Title Behavior Activation Supportive Therapy (ST)
Hide Arm/Group Description

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Period Title: Overall Study
Started 111 110
Completed [1] 77 87
Not Completed 34 23
Reason Not Completed
Death             5             4
Withdrawal by Subject             29             19
[1]
Provided data at 24 months
Arm/Group Title Behavior Activation Supportive Therapy (ST) Total
Hide Arm/Group Description

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Total of all reporting groups
Overall Number of Baseline Participants 111 110 221
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 110 participants 221 participants
75.5  (7.1) 76.2  (6.9) 75.8  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 110 participants 221 participants
Female
86
  77.5%
89
  80.9%
175
  79.2%
Male
25
  22.5%
21
  19.1%
46
  20.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 110 participants 221 participants
Hispanic or Latino
1
   0.9%
0
   0.0%
1
   0.5%
Not Hispanic or Latino
110
  99.1%
110
 100.0%
220
  99.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 110 participants 221 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
111
 100.0%
110
 100.0%
221
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 110 participants 221 participants
111 110 221
1.Primary Outcome
Title Number of Participants With a Decline of 6 Points on the Hopkins Verbal Learning Test-Revised (HVLT-R)
Hide Description A decline of 6 points from baseline to 24 months on the Hopkins Verbal Learning Test-Revised (HVLT-R). Possible scores range from 0 to 12, with higher scores indicating better memory.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.
Arm/Group Title Behavior Activation Supportive Therapy (ST)
Hide Arm/Group Description:

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Overall Number of Participants Analyzed 91 99
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.1%
9
   9.1%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavior Activation, Supportive Therapy (ST)
Comments Poisson regression with robust standard errors (GEE) was used to jointly model decline in HVLT-R Total Recall score ≥ 6 words at 6, 12, 18, and 24 months by treatment group. The model included time, treatment, time-by-treatment interaction terms, and baseline HVLT-R Total Recall score.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Poisson regression with robust SE (GEE)
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
0.02 to 0.74
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in University of California Performance-based Skills Assessment (UPSA) Score Per Year
Hide Description The University of California Performance-based Skills Assessment (UPSA) was used as an objective test of accuracy with writing checks, making change, using a telephone, and scheduling a physician appointment (higher scores indicate better function). Possible scores range from 0 to 100.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the modified intent to treat population including all available data from all participants with at least one follow-up visit.
Arm/Group Title Behavior Activation Supportive Therapy (ST)
Hide Arm/Group Description:

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Overall Number of Participants Analyzed 91 99
Mean (95% Confidence Interval)
Unit of Measure: units per year
-.13
(-2.05 to 1.79)
-2.60
(-4.36 to -0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Behavior Activation, Supportive Therapy (ST)
Comments Mixed effects linear regression was used to model the trajectory. Fixed effects for time (as a continuous variable), treatment group, time-by-treatment group interaction, and age at baseline were included. Random intercepts and slopes were included to account for within-subject correlation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .064
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Slopes
Estimated Value 2.47
Confidence Interval (2-Sided) 95%
-.14 to 5.07
Estimation Comments [Not Specified]
Time Frame 2 years
Adverse Event Reporting Description We reported hospitalizations
 
Arm/Group Title Behavior Activation Supportive Therapy (ST)
Hide Arm/Group Description

BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

Behavioral Activation (BA): BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.

ST is a person-centered treatment in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

Supportive Therapy (ST): ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.

All-Cause Mortality
Behavior Activation Supportive Therapy (ST)
Affected / at Risk (%) Affected / at Risk (%)
Total   5/111 (4.50%)      4/110 (3.64%)    
Show Serious Adverse Events Hide Serious Adverse Events
Behavior Activation Supportive Therapy (ST)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/111 (36.04%)      35/110 (31.82%)    
Blood and lymphatic system disorders     
Blood clot   1/111 (0.90%)  1 4/110 (3.64%)  4
Cardiac disorders     
Valve replacement   1/111 (0.90%)  1 1/110 (0.91%)  1
Pacemaker implanted   2/111 (1.80%)  2 1/110 (0.91%)  1
Heart attack   2/111 (1.80%)  2 1/110 (0.91%)  1
bypass surgery   2/111 (1.80%)  2 0/110 (0.00%)  0
Chest pain   0/111 (0.00%)  0 1/110 (0.91%)  1
Edema   1/111 (0.90%)  1 0/110 (0.00%)  0
CHF   1/111 (0.90%)  1 0/110 (0.00%)  0
Endocrine disorders     
hypoglycemia   1/111 (0.90%)  1 0/110 (0.00%)  0
Eye disorders     
internal bleeding   0/111 (0.00%)  0 2/110 (1.82%)  2
Gastrointestinal disorders     
Chrohn's Disease   0/111 (0.00%)  0 1/110 (0.91%)  1
GI bleed   0/111 (0.00%)  0 1/110 (0.91%)  1
Acid reflux   0/111 (0.00%)  0 1/110 (0.91%)  1
GI symptoms   2/111 (1.80%)  2 0/110 (0.00%)  0
Infections and infestations     
Death  [1]  0/111 (0.00%)  0 1/110 (0.91%)  1
UTI   0/111 (0.00%)  0 3/110 (2.73%)  3
infection   1/111 (0.90%)  1 0/110 (0.00%)  0
Investigations     
Death NOS  [2]  5/111 (4.50%)  5 4/110 (3.64%)  4
Musculoskeletal and connective tissue disorders     
Fracture  [3]  1/111 (0.90%)  1 0/110 (0.00%)  0
Broken shoulder   1/111 (0.90%)  1 0/110 (0.00%)  0
Neck pain   0/111 (0.00%)  0 1/110 (0.91%)  1
Hernia repair   1/111 (0.90%)  1 0/110 (0.00%)  0
Knee replacement   4/111 (3.60%)  4 2/110 (1.82%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer   1/111 (0.90%)  1 0/110 (0.00%)  0
Prostate cancer   1/111 (0.90%)  1 2/110 (1.82%)  2
colon cancer   1/111 (0.90%)  1 0/110 (0.00%)  0
Nervous system disorders     
Seziure   1/111 (0.90%)  1 0/110 (0.00%)  0
Headache   0/111 (0.00%)  0 1/110 (0.91%)  1
Psychiatric disorders     
Depression   1/111 (0.90%)  1 1/110 (0.91%)  1
Renal and urinary disorders     
Dehydration   0/111 (0.00%)  0 2/110 (1.82%)  2
Respiratory, thoracic and mediastinal disorders     
Asthma Attack   1/111 (0.90%)  1 0/110 (0.00%)  0
bronchitis   0/111 (0.00%)  0 1/110 (0.91%)  1
COPD   2/111 (1.80%)  2 0/110 (0.00%)  0
pneumonia   1/111 (0.90%)  1 1/110 (0.91%)  1
Vascular disorders     
Stroke   4/111 (3.60%)  4 4/110 (3.64%)  5
aneurysm   1/111 (0.90%)  1 0/110 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Death from septic shock
[2]
Death NOS
[3]
Fractured disk
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Behavior Activation Supportive Therapy (ST)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/111 (0.00%)      0/110 (0.00%)    
The racial characteristics of the sample and motivation to enroll a clinical trial, limit generalizability. Also, nonrandom attrition (higher in males) may have skewed results.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robin Casten
Organization: Thomas Jefferson University
Phone: 215-503-1250
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01299766     History of Changes
Other Study ID Numbers: 1R01AG035025 ( U.S. NIH Grant/Contract )
1R01AG035025 ( U.S. NIH Grant/Contract )
First Submitted: February 16, 2011
First Posted: February 18, 2011
Results First Submitted: September 18, 2018
Results First Posted: November 20, 2018
Last Update Posted: December 12, 2018