Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)
Study Details
Study Description
Brief Summary
The primary intervention offered through this study is a manualized and culturally adapted CBT intervention combined with an exercise intervention, administered by trained Community Health Workers and exercise trainers to ethnic minority elders with moderate to severe mood symptoms and at risk of disability. In addition to the intervention implementation, the study examines how to successfully build collaborative research for the provision of evidence-based mental health and disability prevention treatments for ethnic minority elders in community-based settings. Thus, the study will evaluate the three components necessary for a successful intervention: efficacy, since the intervention must work, acceptability among clients and partnering agencies, and feasibility and sustainability within the organization.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Detailed Description
The researchers have partnered with 5 community-based organizations and 2 clinics, each of whom will recruit 60 elder participants to be randomized into either the intervention (CBT+exercise) or control (enhanced usual care) groups. Each participant randomized into the intervention group will receive 10 sessions of individual CBT for depression and anxiety (Positive Minds), using a translated and culturally adapted manual, and administered by a trained community health worker. In addition, each participant will engage in three exercise groups per week for 12 weeks, using the Increased Velocity Specific to Task (Strong Bodies; InVEST) protocol. Both intervention and control groups will be assessed biweekly for symptoms of depression, anxiety, and suicidality, and both groups will participate in a thorough assessment at baseline, and 2, 6, and 12 months after baseline.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: CBT + InVEST exercise 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. |
Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Active Comparator: 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. |
Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions [6-months post-baseline]
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".
- Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up [6-months post-baseline]
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.
- Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up [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.
- 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. [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.
- 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. [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.
- Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 60+
-
Fluency in English, Spanish, Mandarin or Cantonese
-
Score above threshold on PHQ-9, GAD-7, or Geriatric Depression Scale (GDS-Short Form)
-
Score within threshold of SPPB
Exclusion Criteria:
-
Participants will be excluded if there is evidence of:
-
Current substance use disorders
-
Current or last 3 months of specialty mental health treatment
-
Evidence that patient the participant lacks capacity to consent assessed using the UCSD Brief Assessment of Capacity to Consent.
-
Suicidal risk (score of 4 or 5 on the Paykel suicide questionnaire), whereby participant will be referred for immediate treatment to specialty care
-
If the participant's physician advises against strenuous physical exercise.
-
Exclusion from the disability component will also happen if the participant is home-bound, has an acute or an exacerbated chronic disease, or has neuro-musculoskeletal impairment that prevents them from participating in the exercises
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | King David Foundation | Aventura | Florida | United States | 33180 |
2 | Greater Boston Chinese Golden Age Center | Boston | Massachusetts | United States | 02111 |
3 | MGH Chelsea | Chelsea | Massachusetts | United States | |
4 | Kit Clark Senior Services | Dorchester | Massachusetts | United States | 02122 |
5 | MGH Revere | Revere | Massachusetts | United States | |
6 | Central Harlem Senior Citizens' Center | New York | New York | United States | 10037 |
7 | Hamilton Madison City Hall Senior Center | New York | New York | United States | 10038 |
8 | University of Puerto Rico | San Juan | Puerto Rico |
Sponsors and Collaborators
- Massachusetts General Hospital
- New York University
- Vanderbilt University
Investigators
- Principal Investigator: Margarita Alegria, PhD, Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 1R01AG046149-01A1
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
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 | 118 | 0 |
Completed InVEST | 63 | 0 |
Completed CBT + InVEST Exercise | 122 | 0 |
Completed Enhanced Usual Care | 0 | 148 |
COMPLETED | 122 | 148 |
NOT COMPLETED | 31 | 6 |
Baseline Characteristics
Arm/Group Title | CBT + InVEST Exercise | Enhanced Usual Care | Total |
---|---|---|---|
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 Participants | 153 | 154 | 307 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
9
5.9%
|
12
7.8%
|
21
6.8%
|
>=65 years |
144
94.1%
|
142
92.2%
|
286
93.2%
|
Age (years) [Mean (Full Range) ] | |||
Mean (Full Range) [years] |
74.86
|
75.44
|
75.15
|
Sex: Female, Male (Count of Participants) | |||
Female |
123
80.4%
|
125
81.2%
|
248
80.8%
|
Male |
30
19.6%
|
29
18.8%
|
59
19.2%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
64
41.8%
|
72
46.8%
|
136
44.3%
|
Not Hispanic or Latino |
64
41.8%
|
55
35.7%
|
119
38.8%
|
Unknown or Not Reported |
25
16.3%
|
27
17.5%
|
52
16.9%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
2
1.3%
|
6
3.9%
|
8
2.6%
|
Asian |
51
33.3%
|
51
33.1%
|
102
33.2%
|
Native Hawaiian or Other Pacific Islander |
NA
NaN
|
NA
NaN
|
NA
NaN
|
Black or African American |
15
9.8%
|
14
9.1%
|
29
9.4%
|
White |
50
32.7%
|
47
30.5%
|
97
31.6%
|
More than one race |
26
17%
|
30
19.5%
|
56
18.2%
|
Unknown or Not Reported |
9
5.9%
|
6
3.9%
|
15
4.9%
|
Region of Enrollment (participants) [Number] | |||
United States |
153
100%
|
154
100%
|
307
100%
|
Hopkins Symptom Checklist-25 (HSCL-25) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
1.62
(.42)
|
1.63
(.46)
|
1.62
(.44)
|
Short Physical Performance Battery (SPPB) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
7.58
(2.30)
|
7.38
(2.03)
|
7.48
(2.17)
|
Function Component of the Late Life Functioning and Disability Instrument (LLFDI) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
118.42
(25.96)
|
116.75
(26.20)
|
117.58
(26.05)
|
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
21.97
(7.09)
|
22.40
(7.86)
|
22.19
(7.48)
|
Generalized Anxiety Disorder 7-item Scale (GAD-7) (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
6.18
(4.63)
|
5.79
(4.56)
|
5.99
(4.59)
|
Outcome Measures
Title | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With the Intervention Sessions |
---|---|
Description | 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". |
Time Frame | 6-months post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
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. |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 0 |
CBT |
118
77.1%
|
|
InVEST |
63
41.2%
|
|
CBT and InVEST |
58
37.9%
|
|
Satisfaction (very satisfied) |
121
79.1%
|
Title | Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up |
---|---|
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. |
Time Frame | 6-months post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
Intent to treat population (all participants assigned to CBT + InVEST exercise or Enhanced Usual Care). Multiple imputation by chained equations (MICE) imputation method. |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 154 |
Mean (Standard Error) [units on a scale] |
1.44
(.030)
|
1.56
(.038)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CBT + InVEST Exercise, Enhanced Usual Care |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <0.01 |
Comments | Threshold for statistical significance was p<0.05 | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Slope |
Estimated Value | -0.12 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up |
---|---|
Description | 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. |
Time Frame | 6-months post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 154 |
Mean (Standard Error) [units on a scale] |
7.89
(0.22)
|
7.29
(0.19)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CBT + InVEST Exercise, Enhanced Usual Care |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.03 |
Comments | Threshold for statistical significance was p<0.05 | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Slope |
Estimated Value | 0.60 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | 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. |
---|---|
Description | 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. |
Time Frame | 6-months post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 154 |
Mean (Standard Error) [units on a scale] |
120.87
(2.34)
|
114.87
(2.16)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CBT + InVEST Exercise, Enhanced Usual Care |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.02 |
Comments | Threshold for statistical significance was p<0.05 | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Slope |
Estimated Value | 6.00 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | 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. |
---|---|
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. |
Time Frame | 6-months post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 154 |
Mean (Standard Error) [units on a scale] |
21.23
(0.66)
|
22.47
(0.69)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CBT + InVEST Exercise, Enhanced Usual Care |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.15 |
Comments | Threshold for statistical significance was p<0.05 | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Slope |
Estimated Value | -1.24 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up |
---|---|
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. |
Time Frame | 6-moths post-baseline |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
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. Comparison of a combined CBT + exercise intervention and 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 |
Measure Participants | 153 | 154 |
Mean (Standard Error) [units on a scale] |
4.80
(0.38)
|
5.29
(0.39)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | CBT + InVEST Exercise, Enhanced Usual Care |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.35 |
Comments | Threshold for statistical significance was p<0.05 | |
Method | Mixed Models Analysis | |
Comments | ||
Method of Estimation | Estimation Parameter | Slope |
Estimated Value | -0.49 | |
Confidence Interval |
(2-Sided) % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Adverse Events
Time Frame | 1 year | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
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. | ||
All Cause Mortality |
||||
CBT + InVEST Exercise | Enhanced Usual Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/153 (2.6%) | 1/154 (0.6%) | ||
Serious Adverse Events |
||||
CBT + InVEST Exercise | Enhanced Usual Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/153 (0%) | 0/154 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
CBT + InVEST Exercise | Enhanced Usual Care | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/153 (0%) | 0/154 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Margarita Alegria, PI |
---|---|
Organization | Disparities Research Unit, MGH |
Phone | 617-724-1237 |
malegria@mgh.harvard.edu |
- 1R01AG046149-01A1