跳至主要内容
临床试验/NCT06093282
NCT06093282Enrolling By Invitation不适用

Activity and Recreation in Communities for Health (ARCH) - Pilot Study

Rush University Medical Center1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
102
试验地点
1
主要终点
Depressive symptoms

研究概览

简要总结

This project tests whether a health outreach intervention that promotes engagement in rewarding, community-based recreational and social activities can produce greater improvements in depressive symptoms, adiposity, and physical activity among people from underresourced communities than traditional health outreach approaches.

详细描述

Underresourced communities are affected by structural barriers and detrimental conditions that contribute to disparities in mental and physical health. People living in these communities may also face financial and logistical barriers to engaging in meaningful and rewarding activities in their community, which is linked to risk for depression and cardiometabolic disease in emerging health behavior models. There is also evidence that depression, physical inactivity, and reward-driven overeating exhibit reciprocal causal relationships that promote cardiometabolic disease through multiple pathways, which supports the value of intervening on these co-occurring risk factors simultaneously. Structured interventions that increase engagement in rewarding activities are effective for treating depression, but this approach has not been adapted for broad dissemination in underresourced populations that face challenges accessing the health care system, and have a high burden of cardiometabolic risk factors.

This project will refine and test a novel approach for reducing the burden of depression and cardiometabolic disease in underresourced communities. The Activity and Recreation in Communities for Health (ARCH) intervention is designed to promote engagement in rewarding activities through an adaptation of Behavioral Activation Treatment for Depression, and direct provision of resources to engage in rewarding recreational and social activities both independently and through our partnering community-based organizations. ARCH is designed to be delivered in participants' homes and community venues by a health outreach workforce, which addresses barriers to accessing treatment. Aim 1 is to engage community stakeholders in the process of co-designing ARCH to maximize feasibility, acceptability, and uptake. Aim 2 is to conduct an initial evaluation of the refined ARCH intervention among adults from underresourced communities with depression. Changes in depressive symptoms, adiposity, and physical activity over four months will be compared between those randomly assigned to ARCH versus a traditional health outreach comparator. In addition to clinical outcomes, key metrics of program uptake, cost, and feasibility will be quantified, and hypothesized mechanisms underlying treatment effects will be explored (Aim 3). Findings will inform the design of a definitive implementation trial, and determine the potential value of incorporating behavioral activation in other outreach interventions for underserved populations

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

Outcomes assessors and the Investigators are blinded to individual participants' treatment assignment.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Member of an underserved population defined by either of the following:
  • Received health care at a federally qualified health center within the past 2 years
  • Living in a neighborhood with an Area Deprivation Index ≤ 20th percentile
  • Elevated depressive symptoms (10-item CES-D score≥10)94,95
  • One or both of the following modifiable cardiometabolic risk factors:
  • Excess adiposity (body mass index ≥ 28.0 kg/m2)
  • Physically inactive according to the 2018 U.S. Physical Activity Guidelines:96 less than 150 minutes of moderate intensity, 75 minutes of vigorous intensity, or an equivalent combination of moderate and vigorous intensity activity, per week based on a 7-day accelerometry protocol

排除标准

  • Under 18 years of age
  • Not fluent in English
  • Uncontrolled serious mental illness
  • High risk for suicidality on the Columbia Suicide Severity Scale
  • Conditions jeopardizing staff safety at home data visits
  • Individual is dependent on a caretaker for activities of daily living
  • Currently lives or plans to move outside Cook and Lake Counties

研究组 & 干预措施

ARCH

Experimental

4-month health outreach intervention to improve depressive symptoms, physical activity, and weight management

干预措施: ARCH (Behavioral)

Traditional Health Outreach

Active Comparator

4-month health outreach intervention focused on screening, referral to healthcare resources, and support

干预措施: Traditional Health Outreach (Behavioral)

结局指标

主要结局

Depressive symptoms

时间窗: 4 months

Change in depressive symptoms on the 10-item version of the Centers for Epidemiological Studies - Depression Scale (CES-D-10)

次要结局

  • Physical activity(4 months)
  • Weight loss(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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