Trial Outcomes & Findings for Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies) (NCT NCT02317432)
NCT ID: NCT02317432
Last Updated: 2021-04-28
Results Overview
The number of participants attending more than 50% of intervention sessions was measured in three ways: (1) number attending 50% or more of the CBT sessions (CBT), (2) number attending 50% or more of the InVEST exercise sessions (InVEST), and (3) number attending 50% or more of the CBT and InVEST sessions (CBT and InVEST). Satisfaction with the intervention sessions was measured as the number of participants reporting to be "very satisfied".
COMPLETED
NA
307 participants
6-months post-baseline
2021-04-28
Participant Flow
Participant milestones
| Measure |
CBT + InVEST Exercise
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
|
Enhanced Usual Care
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
154
|
|
Overall Study
Completed CBT
|
118
|
0
|
|
Overall Study
Completed InVEST
|
63
|
0
|
|
Overall Study
Completed CBT + InVEST Exercise
|
122
|
0
|
|
Overall Study
Completed Enhanced Usual Care
|
0
|
148
|
|
Overall Study
COMPLETED
|
122
|
148
|
|
Overall Study
NOT COMPLETED
|
31
|
6
|
Reasons for withdrawal
| Measure |
CBT + InVEST Exercise
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
|
Enhanced Usual Care
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
|
|---|---|---|
|
Overall Study
Death
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
|
Overall Study
Did not complete any CBT/InVEST sessions or the recommended number of sessions
|
27
|
0
|
Baseline Characteristics
Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
Baseline characteristics by cohort
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
144 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
286 Participants
n=206 Participants
|
|
Age, Continuous
|
74.86 years
n=99 Participants
|
75.44 years
n=107 Participants
|
75.15 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=99 Participants
|
125 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
64 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
26 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=99 Participants
|
154 participants
n=107 Participants
|
307 participants
n=206 Participants
|
|
Hopkins Symptom Checklist-25 (HSCL-25)
|
1.62 units on a scale
STANDARD_DEVIATION .42 • n=99 Participants
|
1.63 units on a scale
STANDARD_DEVIATION .46 • n=107 Participants
|
1.62 units on a scale
STANDARD_DEVIATION .44 • n=206 Participants
|
|
Short Physical Performance Battery (SPPB)
|
7.58 units on a scale
STANDARD_DEVIATION 2.30 • n=99 Participants
|
7.38 units on a scale
STANDARD_DEVIATION 2.03 • n=107 Participants
|
7.48 units on a scale
STANDARD_DEVIATION 2.17 • n=206 Participants
|
|
Function Component of the Late Life Functioning and Disability Instrument (LLFDI)
|
118.42 units on a scale
STANDARD_DEVIATION 25.96 • n=99 Participants
|
116.75 units on a scale
STANDARD_DEVIATION 26.20 • n=107 Participants
|
117.58 units on a scale
STANDARD_DEVIATION 26.05 • n=206 Participants
|
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
|
21.97 units on a scale
STANDARD_DEVIATION 7.09 • n=99 Participants
|
22.40 units on a scale
STANDARD_DEVIATION 7.86 • n=107 Participants
|
22.19 units on a scale
STANDARD_DEVIATION 7.48 • n=206 Participants
|
|
Generalized Anxiety Disorder 7-item Scale (GAD-7)
|
6.18 units on a scale
STANDARD_DEVIATION 4.63 • n=99 Participants
|
5.79 units on a scale
STANDARD_DEVIATION 4.56 • n=107 Participants
|
5.99 units on a scale
STANDARD_DEVIATION 4.59 • n=206 Participants
|
PRIMARY outcome
Timeframe: 6-months post-baselinePopulation: Analysis population includes only participants in the CBT + InVEST exercise group because the outcome (number of participants attending more than 50% of the intervention sessions and reporting satisfaction with the intervention sessions) cannot be measured for participants in the Enhanced Usual Care group since they did not receive the intervention sessions.
The number of participants attending more than 50% of intervention sessions was measured in three ways: (1) number attending 50% or more of the CBT sessions (CBT), (2) number attending 50% or more of the InVEST exercise sessions (InVEST), and (3) number attending 50% or more of the CBT and InVEST sessions (CBT and InVEST). Satisfaction with the intervention sessions was measured as the number of participants reporting to be "very satisfied".
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
CBT
|
118 Participants
|
—
|
|
Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
InVEST
|
63 Participants
|
—
|
|
Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
CBT and InVEST
|
58 Participants
|
—
|
|
Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions
Satisfaction (very satisfied)
|
121 Participants
|
—
|
PRIMARY outcome
Timeframe: 6-months post-baselinePopulation: Intent to treat population (all participants assigned to CBT + InVEST exercise or Enhanced Usual Care). Multiple imputation by chained equations (MICE) imputation method.
The HSCL-25 is a 25-item screener of mood symptoms (ten anxiety symptoms and 15 depressive symptoms). Respondents are asked how much they were bothered by each symptom in the last four weeks, with responses rated on a 4-point scale (1 = not at all and 4 = extremely). Total scores are computed averaging all items (range: 1-4), and higher scores represent worse symptoms.
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up
|
1.44 units on a scale
Standard Error .030
|
1.56 units on a scale
Standard Error .038
|
PRIMARY outcome
Timeframe: 6-months post-baselineThe SPPB is an objective assessment tool developed by the National Institute of Aging to evaluate lower extremity functioning in older persons. It includes three tests (subscales) of functional relevance: standing balance, 4-meter gait speed, and five-repetition sit-to-stand motion. Each of the three components is scored on a 5-point subscale from 0 (unable to perform or low performance) to 4 (high performance). These three subscales are added to obtain a summary score than ranges between 0 and 12, with higher scores representing higher performance of physical functioning.
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up
|
7.89 units on a scale
Standard Error 0.22
|
7.29 units on a scale
Standard Error 0.19
|
PRIMARY outcome
Timeframe: 6-months post-baselineThe Function Component of the LLFDI is a 32-item self-reported measure assessing difficulty in performing discrete daily physical activities in older adults. Respondents are asked about difficulties performing an activity without help from someone else or the use of assisted devices, with responses rated on a 5-point scale (1 = cannot do and 5 = none). Total scores are calculated summing all items (range: 32-160), and lower scores (approaching 32) are worse as they indicate more difficulties performing discrete daily activities, while higher scores are better as they indicate less difficulties.
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Change in Self-reported Level of Functioning in the Function Component of the Late Life Functioning and Disability Instrument (LLFDI) From Baseline, at 6-month Follow-up.
|
120.87 units on a scale
Standard Error 2.34
|
114.87 units on a scale
Standard Error 2.16
|
PRIMARY outcome
Timeframe: 6-months post-baselineThe WHODAS 2.0 is a 12-item measure of level of functioning in six domains of life: Cognition, mobility, self-care, getting along, life activities, and participation. Respondents are asked about functioning difficulties experienced in the last 30 days, with responses rated on a 5-point scale (1 = none and 5 = extreme or cannot do). Final scores are calculated summing all items (range: 12-60), and higher scores represent more difficulties.
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Change in Level of Functioning in the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) From Baseline, at 6-month Follow-up.
|
21.23 units on a scale
Standard Error 0.66
|
22.47 units on a scale
Standard Error 0.69
|
PRIMARY outcome
Timeframe: 6-moths post-baselineThe GAD-7 is a 7-item self-reported tool to identify probable cases of Generalized Anxiety Disorder. Respondents are asked how often, during the last two weeks, they were bothered by each symptom, with responses rated on a 4-point scale (0 = not at all and 3 = nearly every day). Total scores are calculated summing all items (range: 0-21), and higher scores represent worse symptoms.
Outcome measures
| Measure |
CBT + InVEST Exercise
n=153 Participants
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Enhanced Usual Care
n=154 Participants
Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders.
Comparison of a combined CBT + exercise intervention and enhanced usual care
|
|---|---|---|
|
Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up
|
4.80 units on a scale
Standard Error 0.38
|
5.29 units on a scale
Standard Error 0.39
|
Adverse Events
CBT + InVEST Exercise
Enhanced Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place