A Randomized Trial Evaluating Acceptance and Commitment Therapy and Smart Phone Care Management Application to Augment Buprenorphine Therapy for Opioid Use and Chronic Pain.

Laurie Gallo, Yash Bhambhani, Tiffany Lu, Samuel Holzman, Yuhua Bao, Regina Musicaro, Chloe Roske, Jasmin T Richard, Gustavo E Delgado, Zoe Baker, Joanna Starrels, Angela L Stotts, Yuting Deng, Caryn R R Rodgers, Hector R Perez, Brianna T Norton, Vilma Gabbay
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Abstract

There is high comorbidity of opioid use disorder (OUD) and chronic pain (CP), which is often addressed by prescribing buprenorphine (BUP). While BUP is effective in preventing overdose, it does not address the psychological aspects of OUD and CP comorbidity and treatment retention rates are as low as 50%. The Virtual Opioid use disorder Integrated Chronic Pain Treatment (VOICE) study (NCT05039554) is a novel effectiveness-implementation trial to test a 12-week virtual group Acceptance and Commitment Therapy (ACT) protocol and a care management smartphone application (app; Valera Health) on pain and opioid use in patients with OUD and CP receiving BUP. Using a 2 × 2 factorial design, participants (expected N = 280) are randomized into: ACT, Valera app, ACT + Valera, or Treatment as Usual arm. This study is taking place in the Bronx, NY, a racially/ethnically diverse community that faces numerous socioeconomic stressors and is one of the nation's epicenters of the opioid epidemic. We created a culturally responsive ACT group protocol, and Valera psychoeducational material. Outcome measures include NIH HEAL Common Data Elements and ACT and Valera-specific measures. We are conducting a novel 2 × 2 trial investigating augmenting BUP treatment with ACT and Valera, with the goal that improved mental health and access to care will result in decreased and opioid use and pain interference.

一项随机试验,评估接受与承诺疗法和智能手机护理管理应用对丁丙诺啡疗法治疗阿片类药物使用和慢性疼痛的辅助作用。
阿片类药物使用失调症(OUD)和慢性疼痛(CP)的并发率很高,通常通过处方丁丙诺啡(BUP)来解决。虽然丁丙诺啡能有效防止用药过量,但它并不能解决阿片类药物使用障碍和慢性疼痛并发症的心理问题,而且治疗保持率低至 50%。虚拟阿片类药物使用障碍综合慢性疼痛治疗(VOICE)研究(NCT05039554)是一项新颖的有效性实施试验,旨在测试为期 12 周的虚拟小组接受与承诺疗法(ACT)方案和护理管理智能手机应用程序(应用程序;Valera Health)对接受 BUP 治疗的 OUD 和 CP 患者的疼痛和阿片类药物使用情况的影响。采用 2 × 2 因式设计,将参与者(预计人数 = 280)随机分配到 ACT、Valera 应用程序、ACT 和 Valera 应用程序中:ACT、Valera 应用程序、ACT + Valera 或常规治疗组。这项研究在纽约布朗克斯区进行,这是一个种族/民族多元化的社区,面临着众多社会经济压力,也是全国阿片类药物流行的中心之一。我们制定了符合文化特点的 ACT 小组方案,并编写了 Valera 心理教育材料。结果测量包括 NIH HEAL 通用数据元素以及 ACT 和 Valera 特定测量。我们正在进行一项新颖的 2 × 2 试验,研究用 ACT 和 Valera 来增强 BUP 治疗,目的是改善心理健康和获得护理的机会,从而减少阿片类药物的使用和疼痛干扰。
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