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临床试验/NCT06285032
NCT06285032已完成不适用

Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse

University of Washington1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2024年8月9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
102
试验地点
1
主要终点
Opioid Misuse

研究概览

简要总结

Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

详细描述

Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder.

Aims

  • To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids
  • To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients.
  • To determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes, including opioid dose, functional status and patient-reported pain outcomes in the pilot randomized clinical effectiveness trial.

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

入选标准

  • 18 years or older
  • English-speaking
  • On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids [functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies])
  • With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale
  • Have a chronic pain diagnosis

排除标准

  • Have cancer-related pain
  • Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
  • Have an upcoming scheduled surgery
  • Severe cognitive impairment or active psychosis

研究组 & 干预措施

Cognitive Behavioral Therapy (CBT)

Experimental

Participants will be randomized to the CBT group (N=34). CBT groups will meet for 1 hour via Zoom, for 8 weeks.

干预措施: Cognitive Behavior Therapy (CBT) (Behavioral)

Social Navigation Group

Experimental

Participants will be randomized to the social navigation group (N=34). Social navigation group will meet for 30 mins via Zoom, for 8 weeks.

干预措施: Social Navigation Group (Behavioral)

Usual Care Group

Experimental

Participants will be randomized to the usual care group (N=34). Participants in this group will resume to their usual standard of care for 8 weeks.

干预措施: Controlled Group (Behavioral)

结局指标

主要结局

Opioid Misuse

时间窗: Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.

The primary outcome is to see changes in opioid misuse, which the investigators will measure using the Current Opioid Misuse Measure (COMM). The investigators will give the COMM at baseline, post-intervention (2 weeks after intervention completion), and 3 months after the intervention has been completed to find out changes in behaviors. Those with a score of 9 or greater are consider positive for misuse (min=0, max score=68).

次要结局

  • Determine Functional Outcome(Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.)

研究者

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

Sebastian Tong

Assistant Professor: School of Family Medicine

University of Washington

研究点 (1)

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