Mindfulness Texting for Medication Adherence and Chronic Pain Management (MiMA)
Integrating Mindfulness and mHealth Approaches for Treating Opioid Use Disorder and Chronic Pain
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)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Frank Schwebel, PhD
- 電話番号：505-456-3014
- メール：textlabresearch@gmail.com
研究場所
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New Mexico
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Albuquerque、New Mexico、アメリカ、87131
- 募集
- University of New Mexico
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コンタクト：
- Frank Schwebel, PhD
- 電話番号：505-456-3014
- メール：textlabresearch@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Mindfulness curriculum
Participants in this condition receive two mindfulness messages per day at random times as part of a curriculum based on the ACT+MBRP treatment manual.
|
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.
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|
実験的：Random mindfulness messages
Participants in this condition receive four random mindfulness messages per day at random times from the complete bank of mindfulness messages developed based on the Monitoring and Acceptance Theory of mindfulness.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Engagement with mindfulness text messages
時間枠：Measured daily for six weeks
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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).
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Measured daily for six weeks
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Intervention acceptability
時間枠：From baseline to 12-week (i.e., 3-month) follow-up
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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.
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From baseline to 12-week (i.e., 3-month) follow-up
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Intervention feasibility
時間枠：From baseline to 12-week (i.e., 3-month) follow-up
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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.
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From baseline to 12-week (i.e., 3-month) follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived benefits of mindfulness text messages
時間枠：Measured daily for six weeks
|
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).
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Measured daily for six weeks
|
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Mindfulness
時間枠：Measured daily for six weeks
|
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).
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Measured daily for six weeks
|
|
Pain Measurement
時間枠：Measured daily for six weeks
|
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".
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Measured daily for six weeks
|
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Pain interference
時間枠：Measured daily for six weeks
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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).
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Measured daily for six weeks
|
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Medication adherence
時間枠：From baseline to 12-week (i.e., 3-month) follow-up
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Medication adherence will be assessed using daily self-report of medication for opioid use disorder (MOUD) use.
Within-participant adherence will be calculated as the percentage of study days on which participants reported taking their medication as prescribed.
Participants taking medication on at least 80% of study days will be classified as adherent.
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From baseline to 12-week (i.e., 3-month) follow-up
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Craving
時間枠：Measured daily for six weeks
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Craving is assessed using two items asking participants to rate the strength of their urge and their need to use opioids on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
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Measured daily for six weeks
|
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Self-efficacy
時間枠：Measured daily for six weeks
|
Self-efficacy is assessed using a single item asking participants to rate their confidence in their ability to not use opioids on an 11-point response scale ranging from 0 (not at all) to 10 (very much).
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Measured daily for six weeks
|
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Values
時間枠：Measured daily for six weeks
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Values-based living is assessed using two items adapted from the Values Tracker for ecological momentary assessment (EMA).
The items measure engagement in actions that contribute to participants' quality of life and progress toward life areas that are important to them.
Responses are made on an 11-point scale ranging from 0 (not at all) to 10 (extremely).
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Measured daily for six weeks
|
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Opioid misuse
時間枠：Measured daily for six weeks
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Opioid misuse is assessed using a single item asking participants to endorse whether or not they have used non-prescription or prescription opioids more frequently than prescribed since they last completed a survey.
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Measured daily for six weeks
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Withdrawal symptoms
時間枠：Measured daily for six weeks
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Withdrawal symptoms are assessed using one binary item asking whether participants experienced opioid withdrawal symptoms since the previous assessment and one 11-point rating assessing current withdrawal severity (0 = not at all to 10 = very much).
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Measured daily for six weeks
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2405127629
- RM1DA055301 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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