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Objectives <p>Digital delivery can increase access to mindfulness-based treatments (MBTs) for substance use disorder (SUD). Primary aims in this single-site pilot feasibility&#xa0;randomized controlled trial were to evaluate (1) feasibility and acceptability of an 8-week app-based MBT for SUD, called Mindful Journey, and (2) feasibility of study procedures. We also examined within-condition changes in substance use (assessed via interviews), and substance-related problems and psychological distress (assessed via self-report measures).</p> Method <p>Individuals (<i>n</i> = 36) with SUDs were randomized to outpatient treatment-as-usual (TAU) + Mindful Journey or TAU only. Ecological momentary assessment (EMA) was administered before and after treatment to assess mechanisms (e.g., emotion regulation).</p> Results <p>Participants randomized to Mindful Journey completed on average 9.4 lessons out of 15. We found high ratings (all &gt; 4 on 5-point scale) across acceptability dimensions (e.g., helpfulness). Qualitative feedback indicated good acceptability. Ninety percent of eligible participants were randomized. Seven participants dropped out after randomization. Completion rates were 72%, 75%, and 64% for the mid-treatment, end-of-treatment, and 2-month follow-up assessments. EMA completion was 66% and 52% at pre- and post-treatment, respectively. Participants in TAU + Mindful Journey reported significant reductions in substance use and substance-related problems (Cohen’s <i>d</i> effect sizes from 0.57 to 1.13; <i>p</i>-values &lt; 0.05) through end of treatment and follow-up, but no changes in psychological distress (<i>p</i> &gt; 0.05). Participants in TAU did not show changes in substance use (<i>p</i>-values &gt; 0.05), yet reported significant reductions in substance-related problems (<i>d</i> = 1.46; <i>p</i> &lt; 0.05) and psychological distress (<i>d</i> = 1.02; <i>p</i> &lt; 0.05) from baseline to end of treatment, though not follow-up (<i>p</i>-values &gt; 0.05). Participants in Mindful Journey did not report significant changes in hypothesized mechanisms (<i>p</i>-values &gt; 0.05).</p> Conclusions <p>Mindful Journey was feasible and acceptable and showed clinical promise. Assessment completion could be improved, and further examination of mechanisms is needed.</p> <p><i>Preregistration</i>:&#xa0;This study was preregistered at ClinicalTrials.gov (NCT05852015).</p>

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Pilot Feasibility Randomized Controlled Trial of Mindful Journey: A Digital Mindfulness-Based Treatment for Substance Use Disorder

  • 期刊论文

  • 发表日期：

    2026年4月23日

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  • Corey Roos,
  • Katie Witkiewitz,
  • Sarah Bowen,
  • Brian Kiluk,
  • Jonathan Bricker,
  • Chung Jung Mun,
  • Emmanuelle Baillet,
  • Maya John,
  • Hedy Kober

摘要

Objectives

Digital delivery can increase access to mindfulness-based treatments (MBTs) for substance use disorder (SUD). Primary aims in this single-site pilot feasibility randomized controlled trial were to evaluate (1) feasibility and acceptability of an 8-week app-based MBT for SUD, called Mindful Journey, and (2) feasibility of study procedures. We also examined within-condition changes in substance use (assessed via interviews), and substance-related problems and psychological distress (assessed via self-report measures).

Method

Individuals (n = 36) with SUDs were randomized to outpatient treatment-as-usual (TAU) + Mindful Journey or TAU only. Ecological momentary assessment (EMA) was administered before and after treatment to assess mechanisms (e.g., emotion regulation).

Results

Participants randomized to Mindful Journey completed on average 9.4 lessons out of 15. We found high ratings (all > 4 on 5-point scale) across acceptability dimensions (e.g., helpfulness). Qualitative feedback indicated good acceptability. Ninety percent of eligible participants were randomized. Seven participants dropped out after randomization. Completion rates were 72%, 75%, and 64% for the mid-treatment, end-of-treatment, and 2-month follow-up assessments. EMA completion was 66% and 52% at pre- and post-treatment, respectively. Participants in TAU + Mindful Journey reported significant reductions in substance use and substance-related problems (Cohen’s d effect sizes from 0.57 to 1.13; p-values < 0.05) through end of treatment and follow-up, but no changes in psychological distress (p > 0.05). Participants in TAU did not show changes in substance use (p-values > 0.05), yet reported significant reductions in substance-related problems (d = 1.46; p < 0.05) and psychological distress (d = 1.02; p < 0.05) from baseline to end of treatment, though not follow-up (p-values > 0.05). Participants in Mindful Journey did not report significant changes in hypothesized mechanisms (p-values > 0.05).

Conclusions

Mindful Journey was feasible and acceptable and showed clinical promise. Assessment completion could be improved, and further examination of mechanisms is needed.

Preregistration: This study was preregistered at ClinicalTrials.gov (NCT05852015).