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".

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 307 participants
• Primary outcome timeframe: 6-months post-baseline
• Results posted on: 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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	12 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	144 Participants n=5 Participants	142 Participants n=7 Participants	286 Participants n=5 Participants
Age, Continuous	74.86 years n=5 Participants	75.44 years n=7 Participants	75.15 years n=5 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	125 Participants n=7 Participants	248 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	64 Participants n=5 Participants	72 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	64 Participants n=5 Participants	55 Participants n=7 Participants	119 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Asian	51 Participants n=5 Participants	51 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) More than one race	26 Participants n=5 Participants	30 Participants n=7 Participants	56 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	153 participants n=5 Participants	154 participants n=7 Participants	307 participants n=5 Participants
Hopkins Symptom Checklist-25 (HSCL-25)	1.62 units on a scale STANDARD_DEVIATION .42 • n=5 Participants	1.63 units on a scale STANDARD_DEVIATION .46 • n=7 Participants	1.62 units on a scale STANDARD_DEVIATION .44 • n=5 Participants
Short Physical Performance Battery (SPPB)	7.58 units on a scale STANDARD_DEVIATION 2.30 • n=5 Participants	7.38 units on a scale STANDARD_DEVIATION 2.03 • n=7 Participants	7.48 units on a scale STANDARD_DEVIATION 2.17 • n=5 Participants
Function Component of the Late Life Functioning and Disability Instrument (LLFDI)	118.42 units on a scale STANDARD_DEVIATION 25.96 • n=5 Participants	116.75 units on a scale STANDARD_DEVIATION 26.20 • n=7 Participants	117.58 units on a scale STANDARD_DEVIATION 26.05 • n=5 Participants
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)	21.97 units on a scale STANDARD_DEVIATION 7.09 • n=5 Participants	22.40 units on a scale STANDARD_DEVIATION 7.86 • n=7 Participants	22.19 units on a scale STANDARD_DEVIATION 7.48 • n=5 Participants
Generalized Anxiety Disorder 7-item Scale (GAD-7)	6.18 units on a scale STANDARD_DEVIATION 4.63 • n=5 Participants	5.79 units on a scale STANDARD_DEVIATION 4.56 • n=7 Participants	5.99 units on a scale STANDARD_DEVIATION 4.59 • n=5 Participants

PRIMARY outcome

Timeframe: 6-months post-baseline

Population: 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-baseline

Population: 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-baseline

The 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-baseline

The 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-baseline

The 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-baseline

The 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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Enhanced Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margarita Alegria, PI

Disparities Research Unit, MGH

Phone: 617-724-1237

Email: malegria@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place