Mindfulness-based Relapse Prevention for Peer Workers

Официальное название

Adapting and Pilot Testing Mindfulness-Based Relapse Prevention for Substance Use Peer Workers

Обзор

Adapt and test the effectiveness of MBRP for substance use peer workers compared to a standard of care (referral to 12-step) control condition on substance use, relapse risk, and burnout among peers in a pilot hybrid type 1 trial. The goal of this clinical trial is to learn if Mindfulness-Based Relapse Prevention can reduce substance use, relapse risk, and burnout among substance use peer workers. The objectives are to: 1. Identify the causes, consequences, and risk and protective factors for relapse among peer workers; 2. Identify peers' preferences related to MBRP content, structure, and delivery; 3. Adapt the MBRP intervention for peer workers; and 4. Assess the preliminary effectiveness and implementation outcomes of the adapted MBRP intervention. Researchers will compare MBRP to referral to 12-step (standard of care) to see if MRBP works to reduce substance use, relapse risk, and burnout. Participants will asked to: * Participate in MBRP (8 weekly 2-hour virtual sessions) * Complete 4 surveys assessing well-being outcomes * Participate in 1 virtual interview about your experience

Вмешательства

• Поведенческое Mindfulness Based Relapse Prevention
  MBRP for peer workers consists of 8 weekly 2-hour virtual sessions.
• Поведенческое Standard of Care
  Referral to 12-step programming

Первичные конечные точки

• Change from baseline in biologically verified substance use at 1, 3, and 6 months as measured by Saliva Drug Assays [Срок оценки: From enrollment to 6 months]
• Change from baseline in self-reported substance use days at 1, 3, and 6 months as measured by the Timeline Follow-Back (TLFB) [Срок оценки: From enrollment to 6 months]
• Change from baseline in relapse warning Signs at 1, 3, and 6 months as measured by the Advance Warning of Relapse (AWARE) Questionnaire [Срок оценки: From enrollment to 6 months]
• Change from baseline in professional quality of life at 1, 3, and 6 months as measured by the Professional Quality of Life Scale (ProQOL) [Срок оценки: From enrollment to 6 months]
• Post-intervention perceived feasibility of the intervention as measured by the Feasibility of Intervention Measure (FIM) [Срок оценки: Immediately after the final intervention session]
• Post-intervention perceived acceptability of the intervention as measured by the Acceptability of Intervention Measure (AIM) [Срок оценки: Immediately after the final intervention session]

Вторичные конечные точки (5)

• Change from baseline in the coping score assessed by the Brief-COPE measure at 6 months [Срок оценки: From enrollment to 6 months]
• Change from baseline in total score of emotion regulation assessed by the Difficulty in Emotion Regulation Scale (DERS) measure at 6 months [Срок оценки: From enrollment to 6 months]
• Change from baseline in total score of perceived stress assessed by the Perceived Stress Scale (PSS-10) measure at 6 months [Срок оценки: From enrollment to 6 months]
• Change from baseline in total score of trait mindfulness assessed by the Five Factor Mindfulness Questionnaire (FFMQ-15) measure at 6 months [Срок оценки: From enrollment to 6 months]
• Change from baseline in total score of acceptance assessed by the Acceptance and Action Questionnaire-II (AAQ-II) measure at 6 months [Срок оценки: From enrollment to 6 months]

Критерии участия

Критерии включения

• Are > 18 years old
• Fluent in English
• Be currently employed in a substance use peer support role
• At-risk for SUD relapse as measured by a craving score of >15 on the adapted Penn Alcohol Craving Scale

Критерии исключения

• Have a cognitive impairment that jeopardizes informed consent
• Actively suicidal or psychotic

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

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Addiction Research Institute — Austin

Публикации

• Witkiewitz K, Bowen S, Harrop EN, Douglas H, Enkema M, Sedgwick C. Mindfulness-based treatment to prevent addictive behavior relapse: theoretical models and hypothesized mechanisms of change. Subst Use Misuse. 2014 Apr;49(5):513-24. doi: 10.3109/10826084.2014.891845. PMID 24611847
• Bowen S, Witkiewitz K, Clifasefi SL, Grow J, Chawla N, Hsu SH, Carroll HA, Harrop E, Collins SE, Lustyk MK, Larimer ME. Relative efficacy of mindfulness-based relapse prevention, standard relapse prevention, and treatment as usual for substance use disorders: a randomized clinical trial. JAMA Psychiatry. 2014 May;71(5):547-56. doi: 10.1001/jamapsychiatry.2013.4546. PMID 24647726
• Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084. PMID 19904665
• Grant S, Colaiaco B, Motala A, Shanman R, Booth M, Sorbero M, Hempel S. Mindfulness-based Relapse Prevention for Substance Use Disorders: A Systematic Review and Meta-analysis. J Addict Med. 2017 Sep/Oct;11(5):386-396. doi: 10.1097/ADM.0000000000000338. PMID 28727663

Идентификаторы

NCT: NCT07741825 · STUDY00009002 · 1K01DA065810-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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