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临床试验/NCT03065049
NCT03065049已完成不适用

Peer-Facilitated Physical Activity Intervention Delivered During Methadone Maintenance

Butler Hospital2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2016年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
Minutes of moderate-to-vigorous physical activity (MVPA)/week

研究概览

简要总结

The primary aim of this study is to develop a feasible, acceptable, and effective multilevel physical activity (PA) intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a methadone clinic. To do so, the investigators will train methadone maintenance treatment (MMT) patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at a large community-based methadone clinic. Through the development of interpersonal relationships and social support, the investigators expect that MMT peers who have successfully navigated challenges associated with PA in this population (i.e. depression, smoking, triggers for drug use in environment) will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

详细描述

Opioid Use Disorders (OUDs) are a highly prevalent and costly public health concern in the United States, with over 2.59 million Americans qualifying for abuse or dependence of opioids in 2015. Methadone maintenance treatment (MMT), involving daily distribution of methadone at regulated clinics, is the most common treatment for opioid use disorder. While MMT has been effective in helping OUD patients improve their quality of life, the overwhelming majority of these patients continue to engage in unhealthy lifestyles (e.g., physical inactivity and cigarette smoking) that lead to significant physical and mental health morbidities. For example, patients in MMT have much higher rates of cardiovascular disease, diabetes, hypertension, obesity, depression, sleep difficulties, and cognitive impairments than age-matched controls, which lead to premature death. Given the mental health, physical health, and drug use related benefits of physical activity (PA), interventions targeting increases in PA in patients receiving MMT could have a significant impact on reducing their overall morbidity and mortality.

To date, few PA studies have been conducted with substance abusing populations - and, only one small pilot study with MMT patients. The goal of this project is to develop a feasible, acceptable and effective multilevel PA intervention that addresses both individual and interpersonal factors that can be easily scalable and delivered in the context of a health care setting (i.e., methadone clinics). To do so, the investigators are proposing to train MMT patients who are already engaging in PA at public health recommended levels to deliver a group-based PA intervention to physically inactive MMT patients at SSTAR Lifeline, a large community-based methadone clinic in Fall River, Massachusetts. Peer-facilitated interventions for self-management skills are common in the care of patients with chronic medical conditions. Peers may play a particularly important role in increasing physical activity in MMT, as this population faces unique and significant barriers to PA (e.g., depression, smoking, minimal social supports). Through the development of interpersonal relationships, the investigators expect that MMT peers who have successfully navigated these challenges will help physically inactive MMT patients increase self-efficacy and motivation for initiating and sustaining PA.

The aims of the study include:

  1. PHASE 1 (Peer-PA Manual Development):
  • To develop a theoretically-informed peer-facilitated PA plus Fitbit (Peer-PA+Fitbit) intervention specific to SSTAR Lifeline, in order to help patients in MMT increase levels of physical activity.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • receiving MMT at SSTAR and planning to remain in treatment for the next 6 months
  • low active (i.e., less than 90 minutes of MIPA per week for the past 6 months)
  • has access to a computer connected to the internet or a smartphone compatible with the Fitbit application

排除标准

  • a history of psychotic disorder or current psychotic symptoms
  • current suicidality or homicidality
  • marked organic impairment according to responses to the diagnostic assessments
  • physical or medical problems that would not allow safe participation in a program of moderate intensity physical activity (i.e., not medically cleared by methadone clinic physician)
  • current pregnancy or intent to become pregnant during the next 12 weeks

结局指标

主要结局

Minutes of moderate-to-vigorous physical activity (MVPA)/week

时间窗: 12 month

Measured by accelerometry

次要结局

  • Acceptability of the Intervention assessed with the Client Satisfaction Questionnaire(12 weeks)
  • level of depressive symptoms(12 month)
  • level of anxiety symptoms(12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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