Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder and Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Engagement with mindfulness text messages
研究概览
简要总结
The goal of this clinical trial is to examine the effects of reminder and mindfulness text messages based on integrated Acceptance and Commitment Therapy and Mindfulness Based Relapse Prevention (ACT+MBRP) on medication adherence and managing craving, pain, mindfulness, and withdrawal symptoms in people taking medications for opioid use disorder and with chronic pain through assessment questions collected six times daily during the course of treatment. The main questions it aims to answer are:
- Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder?
- To what extent do people engage with the daily mindfulness messages?
- Do participants receiving a structured curriculum of mindfulness messages delivered twice daily differ from those receiving randomly selected mindfulness messages delivered four times daily in engagement with the intervention?
- How do the two mindfulness text messaging interventions differ in their effects on intervention engagement, craving, pain, mindfulness, and withdrawal symptoms?
Participants will:
- Receive daily medication reminder text messages for 12 weeks (i.e., 3 months)
- Receive either 2 or 4 mindfulness messages per day for 6 weeks
- Answer brief assessment questions six times per day during the 6-week mindfulness text messaging period
- Complete questionnaires at enrollment (baseline), once each week during the 6-week mindfulness text messaging period (6 total), immediately after the 6-week mindfulness text messaging period (post-treatment), and 6 weeks after the mindfulness text messaging period ends (follow-up)
详细描述
This study will examine the acceptability, feasibility, and effectiveness of mindfulness text messages for increasing adherence to medication for opioid use disorder and helping participants manage pain, pain interference, craving, withdrawal symptoms, and mindfulness. The study sends either two or four daily mindfulness text messages for six weeks as well as daily medication reminder text messages for 12 weeks. Participants in the two message per day condition receive an identical curriculum of messages developed based on the integrated ACT+MBRP manual (e.g., the same messages in the same order). Message delivery time is randomized to one of six windows throughout the day. Participants in the four message per day condition receive four random messages from our pool of over 200 mindfulness messages (e.g., different messages and order for each participant). Message delivery time is also randomized to one of the same six windows throughout the day as the other condition. Participants are blinded to the differences in conditions. Medication adherence will be assessed using daily self-report throughout the study.
The study will compare the effects of the two mindfulness text messaging interventions on craving, pain, pain interference, mindfulness, and medication adherence. Secondary outcomes include engagement with the mindfulness text messages, state mindfulness, values-based living, substance misuse, and self-efficacy. Sixty participants who are initiating or restarting medication for opioid use disorder (e.g., methadone or buprenorphine) and who have chronic pain will be enrolled. Participants will complete baseline questionnaires before beginning the intervention, brief ecological momentary assessment (EMA) questions six times per day during the 6-week mindfulness text messaging period, weekly questionnaires during the intervention (6 total), a post-treatment assessment at the end of the 6-week mindfulness text messaging period, and a follow-up assessment 6 weeks after the intervention ends. Daily medication reminder text messages will continue throughout the 12-week study period.
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
- Single (Participant)
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
- •Age 18 years or older
- •Reside in the United States
- •Own or have access to a mobile phone capable of sending and receiving text messages
- •Have reliable internet access to complete study surveys
- •Be willing and able to comply with all study procedures and remain available for the duration of the study
- •Be interested in receiving medication reminders and mindfulness text messages
- •Be within 2 months of initiating or restarting methadone or buprenorphine treatment for opioid use
- •Report chronic pain (pain lasting at least 3 months)
- •Live in the United States
排除标准
- 未提供
结局指标
主要结局
Engagement with mindfulness text messages
时间窗: Measured daily for six weeks
Engagement with the mindfulness text messages is assessed using one binary item asking whether participants thought about or used any suggestion from the MiMA Study text messages since that morning and one 11-point rating (0 = not at all to 10 = very much) assessing the extent to which participants thought about or used the suggestions. Participants also rate the extent to which the mindfulness text messages helped them manage pain, opioid craving, medication adherence, and withdrawal symptoms (0 = not at all to 10 = very much).
Intervention acceptability
时间窗: From baseline to 12-week (i.e., 3-month) follow-up
Acceptability will be assessed using an adapted message fatigue questionnaire and intervention engagement scale. Items are rated on 5-point Likert scales, with mean scores greater than 3 indicating acceptable levels of intervention satisfaction.
Intervention feasibility
时间窗: From baseline to 12-week (i.e., 3-month) follow-up
Feasibility will be evaluated using recruitment, retention, and survey completion rates. Prespecified benchmarks include recruitment of at least 50% of eligible participants and retention rates of at least 75%, 65%, and 55% at Weeks 3, 6, and 12, respectively. Responding to EMA on 25%, 50%, and 75% of days will indicate a low, medium, and high level of feasibility, respectively.
次要结局
- Pain interference(Measured daily for six weeks)
- Perceived benefits of mindfulness text messages(Measured daily for six weeks)
- Mindfulness(Measured daily for six weeks)
- Pain Measurement(Measured daily for six weeks)
- Medication adherence(From baseline to 12-week (i.e., 3-month) follow-up)
- Craving(Measured daily for six weeks)
- Self-efficacy(Measured daily for six weeks)
- Values(Measured daily for six weeks)
- Opioid misuse(Measured daily for six weeks)
- Withdrawal symptoms(Measured daily for six weeks)