Mindfulness Texting for Medication Adherence and Chronic Pain Management

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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)

Eligibility

Primary outcome measure(s)

• Engagement with mindfulness text messages — 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 — 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 — 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.

Trial sites (1)

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