Mindfulness Texting for Medication Adherence and Chronic Pain Management

Официальное название

Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder and Chronic Pain

Обзор

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: 1. Do daily medication reminder text messages increase medication adherence for people taking medications for opioid use disorder? 2. To what extent do people engage with the daily mindfulness messages? 3. 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? 4. How do the two mindfulness text messaging interventions differ in their effects on intervention engagement, craving, pain, mindfulness, and withdrawal symptoms? Participants will: 1. Receive daily medication reminder text messages for 12 weeks (i.e., 3 months) 2. Receive either 2 or 4 mindfulness messages per day for 6 weeks 3. Answer brief assessment questions six times per day during the 6-week mindfulness text messaging period 4. 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)

Подробное описание

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.

Вмешательства

• Поведенческое Mindfulness text messages
  Over 200 text messages based on concepts from Acceptance and Commitment Therapy (ACT) and Mindfulness-Based Relapse Prevention (MBRP) were developed and are sent to participants each day for 6 weeks. The messages are intended to increase awareness of triggers and "automatic" reactions to triggering experiences, and to consider alternative responses to these experiences.

Первичные конечные точки

• Engagement with mindfulness text messages [Срок оценки: Measured daily for six weeks]
• Intervention acceptability [Срок оценки: From baseline to 12-week (i.e., 3-month) follow-up]
• Intervention feasibility [Срок оценки: From baseline to 12-week (i.e., 3-month) follow-up]

Вторичные конечные точки (10)

• Perceived benefits of mindfulness text messages [Срок оценки: Measured daily for six weeks]
• Mindfulness [Срок оценки: Measured daily for six weeks]
• Pain Measurement [Срок оценки: Measured daily for six weeks]
• Pain interference [Срок оценки: Measured daily for six weeks]
• Medication adherence [Срок оценки: From baseline to 12-week (i.e., 3-month) follow-up]
• Craving [Срок оценки: Measured daily for six weeks]
• Self-efficacy [Срок оценки: Measured daily for six weeks]
• Values [Срок оценки: Measured daily for six weeks]
• Opioid misuse [Срок оценки: Measured daily for six weeks]
• Withdrawal symptoms [Срок оценки: Measured daily for six weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• None

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of New Mexico — Albuquerque

Идентификаторы

NCT: NCT07711795 · 2405127629 · RM1DA055301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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