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临床试验/NCT01828307
NCT01828307已完成不适用

Exercise: Addressing Stress in Relapse Prevention for Substance Use Disorders

St. Louis University1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2013年4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
已完成
入组人数
147
试验地点
1
主要终点
Change in substance use (relapse)

研究概览

简要总结

Relapse contributes significantly to the chronicity of substance use disorders, one of the most costly medical/mental health problems facing our nation. The incorporation of exercise into relapse prevention efforts will address stress, a critical factor in relapse, provide other health benefits, and improve overall quality of life. Combined, these changes will reduce the risk of relapse to substance use while also lessening the burden of this psychiatric disorder upon society

详细描述

About half of all individuals who receive treatment for substance use disorders (SUD) relapse within a year. Stress and an individual's biological response to it are significant predictors of relapse. Thus, interventions that decrease stress and normalize an individual's biological response to stress are desperately needed. Exercise decreases stress and improves the body's regulation of stress. The proposed project will utilize exercise as a novel relapse prevention intervention with individuals who have recently completed inpatient SUD treatment. This project will evaluate the efficacy of a motivational intervention for exercise in a randomized clinical trial of 150 SUD patients beginning Aftercare treatment at the VA St. Louis Health Care System. Participants will be randomized to one of two interventions: (1) standard care (SC), or (2) standard care plus a motivational intervention targeting exercise that lasts for six months. Participants are followed every three months for one year. Results from this study will advance exercise as a new strategy for enhancing stress regulation and prevention of relapse in SUD 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
None

入排标准

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

入选标准

  • •Undergoing residential substance use disorders treatment at VA St. Louis Healthcare System
  • •Age 18 or older
  • •English speaking;
  • •Substance dependence
  • •Recent substance use
  • •Does not have high blood pressure
  • •Documented physician clearance to undergo exercise testing & exercise
  • •Plans to begin Aftercare at the clinic within the next two weeks

排除标准

  • •Severely disruptive behavior
  • •Serious uncontrolled psychiatric disorder
  • •Medical history in the past 6 months that contraindicates exercise
  • •Pregnancy, plans to get pregnant in the next six months.
  • •Currently breastfeeding
  • •Obese - class II
  • •Currently taking corticosteroids or hormonal contraceptives
  • •In recovery for pathological gambling
  • •Opiate dependence.

研究组 & 干预措施

Standard Aftercare Treatment

Active Comparator

Standard aftercare treatment consists of once per week group counseling for six months. Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.

干预措施: Standard Aftercare Treatment (Behavioral)

Standard Aftercare Treatment + Exercise Intervention

Experimental

In addition to attending standard aftercare treatment, participants will receive three 50-minute motivational enhancement therapy sessions focused on exercise, plus 24 weekly contingency management sessions for exercise.

干预措施: Motivational enhancement therapy (MET) (Behavioral)

Standard Aftercare Treatment + Exercise Intervention

Experimental

In addition to attending standard aftercare treatment, participants will receive three 50-minute motivational enhancement therapy sessions focused on exercise, plus 24 weekly contingency management sessions for exercise.

干预措施: Contingency management (Behavioral)

Standard Aftercare Treatment + Exercise Intervention

Experimental

In addition to attending standard aftercare treatment, participants will receive three 50-minute motivational enhancement therapy sessions focused on exercise, plus 24 weekly contingency management sessions for exercise.

干预措施: Standard Aftercare Treatment (Behavioral)

结局指标

主要结局

Change in substance use (relapse)

时间窗: At baseline and every three months for one year.

Relapse is assessed during the duration of the study and is a time to event variable so it will be assess over time. Relapse is defined as drinking alcohol in excess of the National Institute on Alcohol Abuse and Alcohol (NIAAA) at-risk guidelines.

Change in moderate to vigorous physical activity

时间窗: At baseline and every three months for one year.

Moderate to vigorous physical activity frequency, duration and intensity will be assessed over time to examine changes in response to the intervention. Frequency is defined as how often and individual engages in moderate to vigorous physical activity. Duration is the amount of time (minutes) per episode that individual engages in moderate to vigorous physical activity. Intensity is defined two ways: (1) self-report rating of intensity and (2) metabolic equivalent of the moderate to vigorous physical activity.

次要结局

  • Change in stress reactivity over time.(At baseline and two additional times over one year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremiah Weinstock

Associate Professor

St. Louis University

研究点 (1)

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