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临床试验/NCT04836247
NCT04836247已完成不适用

Understanding and Addressing Disclosure to Members of Social Networks Among People Recovering From Substance Use Disorders

University of Delaware2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年7月26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
50
试验地点
2
主要终点
Decision Making Quality

研究概览

简要总结

Many people with substance use disorders struggle with decisions regarding whether to disclose to others that they have a history of substance use and/or are in recovery. Yet, these decisions are important because disclosures can lead to reactions from others that harm or help recovery. For example, stigmatizing responses can harm the mental health of people in recovery whereas supportive responses can strengthen people's commitment to their sobriety. We have developed a brief intervention to help people decide whether and how to tell others about their recovery as well as build skills for disclosure. The purpose of this study is to pilot test this intervention and test its acceptability and feasibility as well as determine if it shows preliminary signs of efficacy in comparison to a control condition. We hypothesize that: (1) participants exposed to the intervention condition will agree that the intervention is acceptable and feasible, and (2) participants in the intervention condition will report higher quality decision making in comparison to participants in the control condition.

详细描述

Data will be collected from participants at two time points, spaced one month apart. All participants will be recruited from the waiting room at a local treatment center. The research assistant will screen interested individuals for eligibility in person and schedule study appointments, which may be coordinated with treatment appointments. All study screening and appointments will be conducted in private spaces at the treatment center. At the first study appointment, the research assistant will introduce the study, check for questions, and obtain consent for the study procedures, medical record review, and follow up procedures. Participants will be randomly assigned to receive either the disclosure intervention or a control intervention (i.e., an evidence-based mindfulness intervention). Following the intervention, participants will complete measures of acceptability, feasibility, and decision quality. At the second study appointment, participants will again be asked to respond to survey and interview questions designed to further evaluate the preliminary efficacy of the intervention. In particular, we will investigate whether participants who completed our disclosure intervention report better relationship outcomes than participants who completed the control condition.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • 18 years or older
  • currently receiving outpatient treatment at the recruitment site
  • are considering disclosing their recovery status to at least one person in the next month
  • have access to a phone that can receive text messages and phone calls

排除标准

  • current diagnosis of severe mental illness

结局指标

主要结局

Decision Making Quality

时间窗: Assessed immediately following intervention delivery, at time 1 study appointment.

Measured informed by recommendations for evaluating patient decision aids (Sepucha et al., 2013), focused on recognition of decision. Mean scores range 1-5, with higher scores indicating greater decision making quality.

Feasibility of Intervention

时间窗: Assessed immediately following intervention delivery, at time 1 study appointment.

Measured with Feasibility of Intervention Measure (adapted from Weiner et al., 2017). Mean scores range 1-5, with higher scores indicating greater feasibility.

Acceptability of Intervention

时间窗: Assessed immediately following intervention delivery, at time 1 study appointment.

Measured with Acceptability of Intervention Measure (adapted from Weiner et al., 2017). Mean scores range 1-5, with higher scores indicating greater acceptability.

次要结局

  • Commitment to Sobriety(Second study appointment out of two. Second appointment took place approximately one month after first study appointment.)
  • Social Support(Second study appointment out of two. Second appointment took place approximately one month after first study appointment.)
  • Enacted Stigma(Second study appointment out of two. Second appointment took place approximately one month after first study appointment.)

研究者

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

Valerie Earnshaw

Associate Professor of Human Development and Family Sciences

University of Delaware

研究点 (2)

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