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临床试验/NCT02846649
NCT02846649已完成不适用

Feasibility and Acceptability of Using an Automated Text Messaging Program to Help Prevent Early Relapse Among Treatment-seeking Opioid Dependent Patients Discharged From the Emergency Department

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8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
20
试验地点
1
主要终点
SMS query completion rate

研究概览

简要总结

The objective is to determine feasibility and acceptability of a text message (SMS)-based relapse prevention intervention as measured through: (1) study retention and SMS query completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease of use. Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment for opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score of >3 and are being discharged to outpatient (community) resources. All participants receive standard of care in the ED, complete a baseline web survey, are asked to text with us for at least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call between day 8 and 14. Investigators expect preliminary findings to support a relapse prevention intervention delivered through SMS. Based on feedback from this mixed methods study, investigators plan to test a refined SMS program in a randomized trial.

详细描述

The vast majority of those with opioid dependence do not receive treatment. This may be due to the limited availability of existing treatment programs and to a range of societal and individual-level barriers, including the stigma associated with identifying oneself as a substance user and difficulty attending a treatment program on a regular basis. Technology-based interventions have potential to help address these barriers and to expand access to evidence-based psychosocial treatment. Automated, computer-based interventions have found high user acceptance and utilization and shown promise in treating substance use disorders. The current study will evaluate a text-message-based psychosocial program called PIER1 (Preventing and Interrupting Early Relapse 1) when delivered to treatment-seeking opioid-dependent emergency department (ED) patients. PIER1 is an interactive program based on the Relapse Prevention Model. It is also informed by cognitive behavioral therapy and motivational interviewing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 18 - 60 years
  • •Seeking treatment for substance abuse (chief complaint of "detox")
  • •English speaking
  • •Opioid dependence (nursing history of opioid use + RODS score>3)
  • •Ownership of a mobile phone with text messaging
  • •Medically and psychologically stable (as determined by the clinician or investigator)

排除标准

  • •No mobile phone ownership or mobile phone without text messaging capabilities
  • •Incarcerated/in police custody
  • •Being treated for a self-inflicted injury or suicidal ideation (as determined by the clinician)
  • •Medical condition affecting cognition (as determined by the clinician or investigator's discretion)
  • •Unable to read, speak, or comprehend English (at the clinician or investigator's discretion)
  • •Patients who are under the influence of illicit drugs or alcohol (at the clinician or investigator's discretion)

研究组 & 干预措施

PIER Intervention

Experimental

The program will help participants learn to recognize the presence of craving and how it can be reduced through environmental, self-regulatory and mood management. Each day, the PIER1 program sends (1) a morning reflection focused on positive thinking, (2) two random prompts assessing severity of craving, (3) feedback specific to managing withdrawal symptoms, mood management, and environmental triggers that are affecting craving, (4) evening assessments of drug use with feedback, (5) goal commitment prompt with feedback, and (6) user-triggered craving assessments with feedback

干预措施: PIER (Behavioral)

结局指标

主要结局

SMS query completion rate

时间窗: 7 days

Investigators will report the percentage of SMS queries replied to over 7 days.

次要结局

  • Ratings of usefulness(7 days)
  • Number of intentional opioid uses(7 days)
  • Number of opioid overdoses(7 days)

研究者

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

Brian Suffoletto

MD, MS

University of Pittsburgh

研究点 (1)

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