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This study aims to address treatment and service disparities and prevent disability among racial/ethnic and linguistic minority elders. It tests the effectiveness and implementation readiness of the Positive Minds-Strong Bodies Enhanced intervention (PMSB-E), a combined mental and physical health intervention designed to be implemented in low-resource community settings. This renewal grant project includes a streamlined intervention with new components designed to improve and maintain participant outcomes.
The Positive Minds-Strong Bodies Enhanced intervention addresses the dual challenges of mental health and physical disability among minority elders. The core Positive Minds intervention includes 10 sessions offered by Community Health Workers over a maximum of 6 months, designed to identify and correct negative distortions or cognitions, promote behavioral activation and encourage supportive relationships. Strong Bodies is a 36-session physical intervention consisting of a series of exercises conducted while wearing a weighted vest in a group setting over 6 months; both interventions include a group maintenance component to maintain gains. The investigators will evaluate the acceptability, effectiveness and twelve-month sustainability of the Enhanced Positive Minds-Strong Bodies intervention (E-PMSB) offered by Community Health Workers (CHWs) and Exercise Trainers in community-based organizations (CBOs) and community clinics. The intervention is offered in English, Spanish, Mandarin or Cantonese.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Minds Strong Bodies Enhanced | Experimental | The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component. |
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| Enhanced Usual Care | Active Comparator | The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Minds Strong Bodies Enhanced | Behavioral | The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | >/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment. This outcome was measured among intervention participants only (Positive Minds Strong Bodies Enhanced) using four indicator variables for attending 5+ (out of 10) PM intervention sessions, 18+ (out of 36) SB intervention sessions, being very satisfied with the care received by intervention provider, and being very satisfied with the program. | 12 months after baseline |
| Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25 | The Hopkins Symptom Checklist-25 (HSCL-25) assessed past 2-week self-reported symptoms of depression and anxiety. The HSCL-25 includes 25 items, each rated from 1 (not at all) to 4 (extremely). Total raw scores are calculated by averaging all items (range 1 to 4, with higher scores indicating more severe symptoms). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of HSCL-25 scores across follow-up assessments, adjusting for baseline HSCL-25 scores. | 3, 6, and 12 months after baseline |
| Physical Functioning as Assessed by Short Physical Performance Battery | The Short Physical Performance Battery (SPPB) objectively assessed physical functioning through balance, gait, and chair-rise timed tests. A summary performance score is calculated by summing categorical rankings on the three tests (range 0 to 12, with higher scores indicating better performance). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of SPPB scores across follow-up assessments, adjusting for baseline SPPB scores. | 3, 6, and 12 months after baseline |
| Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument | The Function Component of the Late-Life Functioning and Disability Instrument (LLFDI) assessed self-reported physical functioning, with 32 items assessing difficulty (1 'cannot do' to 5 'none') to perform discrete actions or activities without the help of someone else or using assistive devices. Total scores are calculated by summing all items (range 32 to 160, with higher scores indicating fewer difficulties). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of LLFDI scores across follow-up assessments, adjusting for baseline LLFDI scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0 | The 12-item version of the WHO Disability Assessment Schedule (WHODAS 2.0) assessed past 30-day self-reported disability to capture difficulty performing activities in six domains of life (1 'none' to 5 'extreme or cannot do'). Total scores are calculated by summing all items (range 12 to 60, with higher scores indicating greater disability). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of WHODAS 2.0 scores across follow-up assessments, adjusting for baseline WHODAS 2.0 scores. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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No significant events in the study occurred after participant enrollment.
Study staff recruited participants through outreach at clinics and community based organization (CBOs) with racially and ethnically diverse, mostly economically disadvantaged clients. Study staff administered a two-part screener, one including self-reported measures and another including an in-person assessment of physical functioning using the Short Physical Performance Battery (SPPB). Between November 20, 2020, and April 15, 2024, study staff assessed 1,287 individuals for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | Positive Minds Strong Bodies Enhanced | The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component. Positive Minds Strong Bodies Enhanced: The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach. |
| FG001 | Enhanced Usual Care | The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety. Enhanced Usual Care: Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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Analysis population followed intent-to-treat principles and included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Positive Minds Strong Bodies Enhanced | The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component. Positive Minds Strong Bodies Enhanced: The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Acceptability | >/= 70% of participants attending >/= 50% of their intervention sessions, reporting satisfaction with treatment. This outcome was measured among intervention participants only (Positive Minds Strong Bodies Enhanced) using four indicator variables for attending 5+ (out of 10) PM intervention sessions, 18+ (out of 36) SB intervention sessions, being very satisfied with the care received by intervention provider, and being very satisfied with the program. | Analysis followed intent-to-treat principles and included all randomized participants to the intervention group | Posted | Count of Participants | Participants | 12 months after baseline |
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12 months
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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 | Positive Minds Strong Bodies Enhanced | The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) consists of 10 sessions focused on mental health (PM) and 36 sessions focused on physical health (SB), along with a group maintenance component. Positive Minds Strong Bodies Enhanced: The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe pain during an exercise training (SB) intervention session | Musculoskeletal and connective tissue disorders | Systematic Assessment | An intervention participant expressed being in severe pain and was taken to the Emergency Department. The participant was released the same day, and the laboratory and imaging studies were all reported as negative. |
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The study was concluded as planned and no technical problems with measurement were experienced.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margarita Alegria | Massachusetts General Hospital | 617-724-1237 | malegria@mgh.harvard.edu |
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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 | Jul 24, 2025 | Mar 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Research staff conducting follow up assessments will be blinded to participant condition in the trial.
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| Enhanced Usual Care | Behavioral | Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. |
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| 3, 6, and 12 months after baseline |
| 3, 6, and 12 months after baseline |
| BG001 | Enhanced Usual Care | The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety. Enhanced Usual Care: Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Hopkins Symptom Checklist-25 (HSCL-25) | The Hopkins Symptom Checklist-25 (HSCL-25) assessed past 2-week self-reported symptoms of depression and anxiety. The HSCL-25 includes 25 items, each rated from 1 (not at all) to 4 (extremely). Total scores are calculated by averaging all items (range 1 to 4, with higher scores indicating more severe symptoms). | Mean | Standard Deviation | units on a scale |
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| Short Physical Performance Battery (SPPB) | The Short Physical Performance Battery (SPPB) objectively assessed physical functioning through balance, gait, and chair-rise timed tests. A summary performance score is calculated by summing categorical rankings on the three tests (range 0 to 12, with higher scores indicating better performance). | Mean | Standard Deviation | units on a scale |
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| Late Life Functioning and Disability Instrument - Function Component (LLFDI) | The Function Component of the Late Life Functioning and Disability Instrument (LLFDI) assessed self-reported physical functioning, with 32 items assessing difficulty (1 'cannot do' to 5 'none') to perform discrete actions or activities without the help of someone else or using assistive devices. Total scores are calculated by summing all items (range 32 to 160, with higher scores indicating fewer difficulties). | Mean | Standard Deviation | units on a scale |
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| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | The 12-item version of the WHO Disability Assessment Schedule (WHODAS 2.0) assessed past 30-day self-reported disability to capture difficulty performing activities in six domains of life (1 'none' to 5 'extreme or cannot do'). Total scores are calculated by summing all items (range 12 to 60, with higher scores indicating greater disability). | Mean | Standard Deviation | units on a scale |
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| OG001 | Enhanced Usual Care | The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety. Enhanced Usual Care: Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. |
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| Primary | Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25 | The Hopkins Symptom Checklist-25 (HSCL-25) assessed past 2-week self-reported symptoms of depression and anxiety. The HSCL-25 includes 25 items, each rated from 1 (not at all) to 4 (extremely). Total raw scores are calculated by averaging all items (range 1 to 4, with higher scores indicating more severe symptoms). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of HSCL-25 scores across follow-up assessments, adjusting for baseline HSCL-25 scores. | Analysis followed intent-to-treat principles and included all randomized participants. | Posted | Least Squares Mean | Standard Error | score on a scale | 3, 6, and 12 months after baseline |
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| Primary | Physical Functioning as Assessed by Short Physical Performance Battery | The Short Physical Performance Battery (SPPB) objectively assessed physical functioning through balance, gait, and chair-rise timed tests. A summary performance score is calculated by summing categorical rankings on the three tests (range 0 to 12, with higher scores indicating better performance). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of SPPB scores across follow-up assessments, adjusting for baseline SPPB scores. | Analysis followed intent-to-treat principles and included all randomized participants. | Posted | Least Squares Mean | Standard Error | score on a scale | 3, 6, and 12 months after baseline |
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| Primary | Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument | The Function Component of the Late-Life Functioning and Disability Instrument (LLFDI) assessed self-reported physical functioning, with 32 items assessing difficulty (1 'cannot do' to 5 'none') to perform discrete actions or activities without the help of someone else or using assistive devices. Total scores are calculated by summing all items (range 32 to 160, with higher scores indicating fewer difficulties). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of LLFDI scores across follow-up assessments, adjusting for baseline LLFDI scores. | Analysis followed intent-to-treat principles and included all randomized participants. | Posted | Least Squares Mean | Standard Error | units on a scale | 3, 6, and 12 months after baseline |
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| Secondary | Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0 | The 12-item version of the WHO Disability Assessment Schedule (WHODAS 2.0) assessed past 30-day self-reported disability to capture difficulty performing activities in six domains of life (1 'none' to 5 'extreme or cannot do'). Total scores are calculated by summing all items (range 12 to 60, with higher scores indicating greater disability). Model-estimated marginal means for each treatment group at each follow-up timepoint were obtained using linear mixed-effects models with repeated measures of WHODAS 2.0 scores across follow-up assessments, adjusting for baseline WHODAS 2.0 scores. | Analysis followed intent-to-treat principles and included all randomized participants. | Posted | Least Squares Mean | Standard Error | score on a scale | 3, 6, and 12 months after baseline |
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| 0 |
| 211 |
| 1 |
| 211 |
| 0 |
| 211 |
| EG001 | Enhanced Usual Care | The Enhanced Usual Care condition includes written materials on depression and anxiety and 4 calls to participants over the course of 6 months to assess symptoms and safety. Enhanced Usual Care: Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. | 3 | 216 | 1 | 216 | 0 | 216 |
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| 'Yes' to thinking, planning, and attempting suicide during the 12-month assessment | Psychiatric disorders | Systematic Assessment | Study staff connected the participant immediately to the BEST emergency services team. The event was determined to be unrelated to the study protocol. |
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| Model-estimated marginal mean at month 12 |
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| Model-estimated marginal mean at month 12 |
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| Model-estimated marginal mean at month 12 |
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| Model-estimated marginal mean at month 12 |
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