Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
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| ClinicalTrials.gov Identifier: NCT02317432 |
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Recruitment Status :
Completed
First Posted : December 16, 2014
Results First Posted : April 28, 2021
Last Update Posted : April 28, 2021
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Sponsor:
Massachusetts General Hospital
Collaborators:
New York University
Vanderbilt University
Information provided by (Responsible Party):
Margarita Alegria, PhD, Massachusetts General Hospital
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention |
| Conditions |
Depression Anxiety Physical Disability |
| Intervention |
Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care |
| Enrollment | 307 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | CBT + InVEST Exercise | Enhanced Usual Care |
|---|---|---|
 Arm/Group Description |
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. | Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders. |
| Period Title: Overall Study | ||
| Started | 153 | 154 |
| Completed CBT [1] | 118 | 0 [2] |
| Completed InVEST [3] | 63 | 0 [4] |
| Completed CBT + InVEST Exercise [5] | 122 | 0 [6] |
| Completed Enhanced Usual Care | 0 [7] | 148 |
| Completed | 122 | 148 |
| Not Completed | 31 | 6 |
| Reason Not Completed | ||
| Death | 4 | 1 |
| Lost to Follow-up | 0 | 5 |
| Did not complete any CBT/InVEST sessions or the recommended number of sessions | 27 | 0 |
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[1]
Completed 50% or more (5 or more) Positive Minds CBT sessions, which is considered the appropriate threshold for populations not recognizing the need for services and not actively seeking treatment.
[2]
Participants in Enhanced Usual Care did not receive CBT sessions.
[3]
Completed 50% or more (18 or more) Strong Minds InVEST sessions, which is considered the appropriate threshold for populations not recognizing the need for services and not actively seeking treatment.
[4]
Participants in Enhanced Usual Care did not receive InVEST sessions.
[5]
Completed either 50% or more Positive Minds CBT sessions or 50% or more Strong Minds InVEST sessions.
[6]
Participants in Enhanced Usual Care did not receive either CBT or InVEST sessions.
[7]
Participants in CBT + InVEST exercise did not receive Enhanced Usual Care.
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Baseline Characteristics
| Arm/Group Title | CBT + InVEST Exercise | Enhanced Usual Care | Total | |
|---|---|---|---|---|
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Arm/Group Description |
10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. | Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 153 | 154 | 307 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
9 5.9%
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12 7.8%
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21 6.8%
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| >=65 years |
144 94.1%
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142 92.2%
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286 93.2%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
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74.86
(62 to 94)
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75.44
(62 to 95)
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75.15
(62 to 95)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| Female |
123 80.4%
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125 81.2%
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248 80.8%
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| Male |
30 19.6%
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29 18.8%
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59 19.2%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| Hispanic or Latino |
64 41.8%
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72 46.8%
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136 44.3%
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| Not Hispanic or Latino |
64 41.8%
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55 35.7%
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119 38.8%
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| Unknown or Not Reported |
25 16.3%
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27 17.5%
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52 16.9%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| American Indian or Alaska Native |
2 1.3%
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6 3.9%
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8 2.6%
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| Asian |
51 33.3%
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51 33.1%
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102 33.2%
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| Native Hawaiian or Other Pacific Islander | NA [1] | NA [1] | NA [2] | |
| Black or African American |
15 9.8%
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14 9.1%
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29 9.4%
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| White |
50 32.7%
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47 30.5%
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97 31.6%
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| More than one race |
26 17.0%
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30 19.5%
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56 18.2%
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| Unknown or Not Reported |
9 5.9%
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6 3.9%
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15 4.9%
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[1]
The race was not an option when collecting data.
[2]
Total not calculated because data are not available (NA) in one or more arms.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 153 participants | 154 participants | 307 participants |
| 153 | 154 | 307 | ||
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Hopkins Symptom Checklist-25 (HSCL-25)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| 1.62 (.42) | 1.63 (.46) | 1.62 (.44) | ||
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[1]
Measure Description: 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.
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Short Physical Performance Battery (SPPB)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| 7.58 (2.30) | 7.38 (2.03) | 7.48 (2.17) | ||
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[1]
Measure Description: The SPPB is an 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.
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Function Component of the Late Life Functioning and Disability Instrument (LLFDI)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| 118.42 (25.96) | 116.75 (26.20) | 117.58 (26.05) | ||
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[1]
Measure Description: The function component of the LLFD 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 scores approaching 32 indicate poor ability.
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World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| 21.97 (7.09) | 22.40 (7.86) | 22.19 (7.48) | ||
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[1]
Measure Description: 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.
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Generalized Anxiety Disorder 7-item Scale (GAD-7)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 153 participants | 154 participants | 307 participants | |
| 6.18 (4.63) | 5.79 (4.56) | 5.99 (4.59) | ||
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[1]
Measure Description: 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.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Margarita Alegria, PI |
| Organization: | Disparities Research Unit, MGH |
| Phone: | 617-724-1237 |
| EMail: | malegria@mgh.harvard.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Margarita Alegria, PhD, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT02317432 |
| Other Study ID Numbers: |
1R01AG046149-01A1 ( U.S. NIH Grant/Contract ) |
| First Submitted: | November 12, 2014 |
| First Posted: | December 16, 2014 |
| Results First Submitted: | March 1, 2021 |
| Results First Posted: | April 28, 2021 |
| Last Update Posted: | April 28, 2021 |