Anxiety, Depression, Physical Disability
Conditions
Keywords
Minority Elders
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALPositive 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.
BEHAVIORALEnhanced 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research staff conducting follow up assessments will be blinded to participant condition in the trial.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Latino, Asian, Black, or non-Latino White adults 60+ years of age * With mild, moderate or severe depressive or anxiety symptoms. * Participants receiving medications for mental health will have this recorded and used as a covariate. * Community-dwelling participants who have some mobility limitations but are not home-bound.
Exclusion criteria
* Any specialty mental health care (therapy sessions with psychiatrist, psychologist or social worker) in the past 3 months or scheduled in the coming month. * Evidence that patient lacks capacity to consent or is cognitively impaired * Current suicidal risk (score of 4 or 5 on Paykel suicide questionnaire), whereby participant will be connected to an emergency services or specialty provider per the study emergency protocol. * Physically instability, acute or exacerbation of a chronic disease, or a neuro-musculoskeletal impairment * Severe substance abuse * Self-reported psychosis or schizophrenia * Inability to commit to 2 sessions per week
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 12 months after baseline | \>/= 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. |
| Depression and Anxiety Symptoms as Assessed by Hopkins Symptom Checklist-25 | 3, 6, and 12 months after baseline | 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. |
| Physical Functioning as Assessed by Short Physical Performance Battery | 3, 6, and 12 months after baseline | 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. |
| Physical Functioning as Assessed by the Function Component of the Late-Life Functioning and Disability Instrument | 3, 6, and 12 months after baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0 | 3, 6, and 12 months after baseline | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
No significant events in the study occurred after participant enrollment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 7.7 |
| Hopkins Symptom Checklist-25 (HSCL-25) | 1.6 units on a scale STANDARD_DEVIATION 0.4 |
| Late Life Functioning and Disability Instrument - Function Component (LLFDI) | 116.6 units on a scale STANDARD_DEVIATION 25 |
| Race/Ethnicity, Customized Race and Ethnicity American Indian | 0 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Asian | 58 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Latino | 99 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Latino Black | 90 Participants |
| Race/Ethnicity, Customized Race and Ethnicity Non-Latino White | 7 Participants |
| Region of Enrollment United States Maryland | 9 Participants |
| Region of Enrollment United States Massachusetts | 269 Participants |
| Region of Enrollment United States New York | 27 Participants |
| Region of Enrollment United States Puerto Rico | 43 Participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 90 Participants |
| Short Physical Performance Battery (SPPB) | 7.9 units on a scale STANDARD_DEVIATION 2.1 |
| World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 23.4 units on a scale STANDARD_DEVIATION 8.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 211 | 3 / 216 |
| other Total, other adverse events | 0 / 211 | 0 / 216 |
| serious Total, serious adverse events | 1 / 211 | 1 / 216 |
Outcome results
None listed