Mindfulness Texting for Medication Adherence and Chronic Pain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of New Mexico
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness text messages
BehavioralOver 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mindfulness curriculumExperimental treatment 1 intervention
Group B: Random mindfulness messagesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Engagement with mindfulness text messages
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).
Time frame
Measured daily for six weeks2
Intervention acceptability
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.
Time frame
From baseline to 12-week (i.e., 3-month) follow-up3
Intervention feasibility
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.
Time frame
From baseline to 12-week (i.e., 3-month) follow-upSecondary outcomes
1
Perceived benefits of mindfulness text messages
Participants indicate how much they believe the mindfulness text messages helped them engage in valued activities, engage in everyday activities, be mindful, and accept thoughts and situations without judgement (response range: 0=not at all, 10=very much).
Time frame
Measured daily for six weeks2
Mindfulness
Mindfulness will be assessed through a 6-item EMA scale that measures state mindfulness in the past 15 minutes. Responses are made on a 5-point response scale ranging from 1 (not at all) to 5 (very much).
Time frame
Measured daily for six weeks3
Pain Measurement
Pain is assessed using a single-item asking participants to rate their current pain compared to their typical pain level. Responses are made on a 10-point response scale ranging from 0 (a lot less than usual) to 10 (a lot more than usual). A response of 5 represents "about the same as usual".
Time frame
Measured daily for six weeks4
Pain interference
Pain interference is assessed using two items assessing interference with what participants are doing and their enjoyment of life. Responses are made on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
Time frame
Measured daily for six weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of New Mexico
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov