Building Community Capacity for Disability Prevention for Minority Elders (Positive Minds - Strong Bodies)

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02317432
Collaborator
New York University (Other), Vanderbilt University (Other)
307
8
2
44
38.4
0.9

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
  • Behavioral: Comparison of a combined CBT + exercise intervention and enhanced usual care
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

Study Type:
Interventional
Actual Enrollment :
307 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Building Community Capacity for Disability Prevention for Minority Elders
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

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

  1. 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".

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Responsible Party:
Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02317432
Other Study ID Numbers:
  • 1R01AG046149-01A1
First Posted:
Dec 16, 2014
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021
Keywords provided by Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
Additional relevant MeSH terms:

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

1. Primary Outcome
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%
2. Primary Outcome
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
3. Primary Outcome
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
4. Primary Outcome
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
5. Primary Outcome
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
6. Primary Outcome
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

[Not Specified]

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
Email malegria@mgh.harvard.edu
Responsible Party:
Margarita Alegria, PhD, Chief, Disparities Research Unit, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02317432
Other Study ID Numbers:
  • 1R01AG046149-01A1
First Posted:
Dec 16, 2014
Last Update Posted:
Apr 28, 2021
Last Verified:
Apr 1, 2021