Building Community Capacity for Disability Prevention for Minority Elders - Renewal
概览
- 阶段
- 不适用
- 干预措施
- Positive Minds Strong Bodies Enhanced
- 疾病 / 适应症
- Depression
- 发起方
- Massachusetts General Hospital
- 入组人数
- 427
- 试验地点
- 2
- 主要终点
- Hopkins Symptom Checklist-25 (change)
- 状态
- 已完成
- 最后更新
- 11天前
概览
简要总结
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.
详细描述
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.
研究者
Margarita Alegria, PhD
Chief, Disparities Research Unit
Massachusetts General Hospital
入排标准
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Positive Minds Strong Bodies Enhanced
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.
干预措施: Enhanced Usual Care
结局指标
主要结局
Hopkins Symptom Checklist-25 (change)
时间窗: Baseline and 3, 6, and 12 months after baseline
Widely used measure of depression and anxiety in clinical monitoring and outcome assessment.
Acceptability
时间窗: 6 months at end of treatment
\>/= 70% of participants attending \>/= 50% of their intervention sessions, reporting satisfaction with treatment.
Late-Life Function and Disability Instrument (LLFDI) - functional component (change)
时间窗: Baseline and 3, 6, and 12 months after baseline
Self-report instrument designed to measure both functional capacity and components of disability.
Short Physical Performance Battery (change)
时间窗: Baseline and 3, 6, and 12 months after baseline
Assessment of standing balance, timed 4-m walk, and timed test of five chair-rise repetitions, to assess functional limitations. A virtual option will be used while in person assessment is not possible due to COVID-19.
Acceptability
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Disability as Assessed by World Health Organization Disability Assessment Schedule 2.0(3, 6, and 12 months after baseline)