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| Name | Class |
|---|---|
| New York University | OTHER |
| Vanderbilt University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT + InVEST exercise | Experimental | 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. |
|
| Enhanced Usual Care | Active Comparator | Usual care, as accessed through the community-based organization, plus written material from the NIH on depression, anxiety, and physical health for elders. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of a combined CBT + exercise intervention and enhanced usual care | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With 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". | 6-months post-baseline |
| Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 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. | 6-months post-baseline |
| Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 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. | 6-months post-baseline |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margarita Alegria, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King David Foundation | Aventura | Florida | 33180 | United States | ||
| Greater Boston Chinese Golden Age Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36339195 | Derived | Zhang L, Cruz-Gonzalez M, Lin Z, Ouyang X, Zhao F, Alegria M. Association of everyday discrimination with health outcomes among Asian and non-Asian US older adults before and during the COVID-19 pandemic. Front Public Health. 2022 Oct 19;10:953155. doi: 10.3389/fpubh.2022.953155. eCollection 2022. | |
| 32885198 | Derived | Porteny T, Alegria M, Del Cueto P, Fuentes L, Markle SL, NeMoyer A, Perez GK. Barriers and strategies for implementing community-based interventions with minority elders: positive minds-strong bodies. Implement Sci Commun. 2020 Apr 30;1:41. doi: 10.1186/s43058-020-00034-4. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CBT + InVEST Exercise | 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 2, 2021 |
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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.
| 6-months post-baseline |
| 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. | 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-months post-baseline |
| Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 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. | 6-moths post-baseline |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| MGH Chelsea | Chelsea | Massachusetts | United States |
| Kit Clark Senior Services | Dorchester | Massachusetts | 02122 | United States |
| MGH Revere | Revere | Massachusetts | United States |
| Central Harlem Senior Citizens' Center | New York | New York | 10037 | United States |
| Hamilton Madison City Hall Senior Center | New York | New York | 10038 | United States |
| University of Puerto Rico | San Juan | PR | Puerto Rico |
| Completed CBT | 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. |
|
| Completed InVEST | 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. |
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| Completed CBT + InVEST Exercise | Completed either 50% or more Positive Minds CBT sessions or 50% or more Strong Minds InVEST sessions. |
|
| Completed Enhanced Usual Care |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CBT + InVEST Exercise | 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Hopkins Symptom Checklist-25 (HSCL-25) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Short Physical Performance Battery (SPPB) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Function Component of the Late Life Functioning and Disability Instrument (LLFDI) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Attending More Than 50% of Intervention Sessions and Number of Participants Reporting Satisfaction With 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". | 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. | Posted | Count of Participants | Participants | 6-months post-baseline |
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| Primary | Change in Mood Symptoms in the Hopkins Symptom Checklist-25 (HSCL-25) From Baseline, at 6-month Follow-up | 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. | Intent to treat population (all participants assigned to CBT + InVEST exercise or Enhanced Usual Care). Multiple imputation by chained equations (MICE) imputation method. | Posted | Mean | Standard Error | units on a scale | 6-months post-baseline |
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| Primary | Change in Functional Limitations in the Short Physical Performance Battery (SPPB) From Baseline, at 6-month Follow-up | 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. | Posted | Mean | Standard Error | units on a scale | 6-months post-baseline |
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| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 6-months post-baseline |
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| Primary | 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. | 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. | Posted | Mean | Standard Error | units on a scale | 6-months post-baseline |
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| Primary | Change in Anxiety Symptoms in the Generalized Anxiety Disorder 7-item Scale (GAD-7) From Baseline, at 6-month Follow-up | 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. | Posted | Mean | Standard Error | units on a scale | 6-moths post-baseline |
|
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CBT + InVEST Exercise | 10 sessions of individual CBT plus 36 sessions of InVEST group exercise, provided over a 12-week intervention period. | 4 | 153 | 0 | 153 | 0 | 153 |
| EG001 | 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. | 1 | 154 | 0 | 154 | 0 | 154 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margarita Alegria, PI | Disparities Research Unit, MGH | 617-724-1237 | malegria@mgh.harvard.edu |
| Apr 2, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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