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临床试验/NCT07519759
NCT07519759招募中不适用

Recovery Inspired Support Engagement (RISE) Pilot

Mclean Hospital1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年9月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
18
试验地点
1
主要终点
Program Completion

研究概览

简要总结

The goal of this clinical trial is to learn if a 1-on-1 support program is easy to complete and acceptable for people supporting loved ones who have recently received treatment for substance use. The main questions it aims to answer are:

How many people complete the program? How satisfied are people with the program?

Participants will:

Complete weekly telehealth sessions for 12 weeks Complete surveys/interviews at the beginning, in the middle (~week 6), at the end of the program (~week 12), and 12-weeks after the end of the program Complete a focus group or interview

详细描述

The program aims to improve support person well-being, social recovery capital, and their loved one's substance use outcomes. Information from support persons and loved ones with a substance use disorder will be collected for program feedback and hypothesis generating purposes. Target enrollment for the clinical trial is 15 pairs of support persons and their loved one. We will plan to recruit 18 pairs of participants in case some people may not complete the study (~15%). Total planned enrollment of support persons (n=18) and their loved ones (n=18) is N=36.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria for Support Persons:
  • Ages 18+.
  • Having a loved one who participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by loved one, support person, clinician, or chart review.
  • Interest in supporting the loved one's recovery from substance use.
  • At least 4 days per month virtual or in-person contact per month with the loved one.
  • Access to a computer with internet or mobile phone with video conferencing capabilities.
  • Ability to provide written informed consent.
  • Speak and read English.
  • Inclusion Criteria for Loved Ones:
  • Ages 18+.
  • Participated in an inpatient or residential substance use disorder program in the past 30 days, as reported by self, support person, clinician, or chart review.
  • At least 4 days per month virtual or in-person contact per month with the support person.
  • Access to a computer with internet or mobile phone with video conferencing capabilities.
  • Ability to provide written informed consent.
  • Speak and read English.

排除标准

  • Exclusion Criteria for Support Persons:
  • DSM-5 moderate or severe substance use disorder in the past year.
  • History of domestic violence with the loved one that would interfere with the ability to safely follow through with the intervention plan.
  • Psychiatric, cognitive, or medical impairments that would interfere with the ability to follow through with the intervention plan.
  • Prior participation of a support person of the loved one in an ITC-related research study.
  • Significant prior experience with ITC or CRAFT (e.g., having completed an ITC-related training workshop or course prior to study enrollment)
  • Exclusion Criteria for Loved Ones: N/A

研究组 & 干预措施

Invitation to Change (ITC)

Experimental

12 weekly individual sessions of 60-minute ITC coaching

干预措施: ITC (Behavioral)

结局指标

主要结局

Program Completion

时间窗: From enrollment to the end of the program (12 weeks).

Proportion of participants completing 12-session program

次要结局

  • Mean Session Satisfaction(From enrollment to the end of the program (12 weeks).)

研究者

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

Julie McCarthy, Ph.D.

Associate Psychologist / Assistant Professor of Psychology

Mclean Hospital

研究点 (1)

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