Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT04545593
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02114, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Massachusetts General Hospital
Other
Building Community Capacity for Disability Prevention for Minority Elders - Renewal
Acronym: PMSB-E
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