Randomized Trial of Acceptance and Commitment Therapy (ACT) and a Care Management App in Primary Care-based Buprenorphine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Pain interference
研究概览
简要总结
The proposed IMPOWR Research Center at Montefiore-Einstein (IMPOWR-ME) will create a multidisciplinary and synergistic program of research to test multimodal treatments that address both chronic pain and opioid use disorder. IMPOWR-ME will generate critical knowledge about the effectiveness, implementation, and cost effectiveness of providing Acceptance and Commitment Therapy and/or a care management smartphone app for individuals in primary care-based buprenorphine treatment. Patients with lived experience with chronic pain and/or opioid use disorder, patient and policy advocates, payors, and health system partners will be engaged in all stages of the research. IMPOWR-ME is well-positioned to become a long-lasting hub for stakeholder-engaged research with multidisciplinary senior and early stage investigators focused on reducing overdose through better treatments for OUD and CP.
详细描述
Chronic pain (CP) and opioid use disorder (OUD) are leading causes of morbidity and mortality in the United States. Despite being commonly comorbid, there is a striking lack of integrated treatments accessible to people in need. This is particularly true for Black and Hispanic individuals living and seeking care in under-resourced settings like The Bronx, New York, one of the poorest and most racially diverse counties in the U.S. Submitted in response to the HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) (Request For Applications ID: RFA-DA-21-030), the overall goal of this proposal is to create the IMPOWR Research Center at Montefiore/Einstein ("IMPOWR-ME"), in the high-impact county of The Bronx New York. IMPOWR-ME is a synergistic multidisciplinary research center that leverages exceptional research infrastructure in CP and OUD and existing relationships with people living with CP and OUD, advocates, policymakers and payers, and health system stakeholders. The aims of IMPOWR-ME are to: 1) create a robust and sustainable research infrastructure to rigorously test and disseminate integrated and cost-effective evidence-based practices for people with CP and OUD; 2) partner with people with lived experience with CP, OUD, or both, and diverse stakeholders in all stages of the research; and 3) provide opportunities for multidisciplinary early stage investigators to become independent researchers focusing on CP and OUD. This innovative hybrid type 1 effectiveness-implementation trial is proposed to rigorously examine multi-modal evidence-based practices in diverse health care settings and populations of people with comorbid CP and OUD. Specifically, the investigators propose a 2x2 factorial trial to test Acceptance and Commitment Therapy and a care management smartphone app for individuals in primary-care based buprenorphine treatment. Participants will have both CP and OUD or opioid misuse, and specific aims will examine CP, OUD, implementation, and cost-effectiveness outcomes; additional patient-centered outcomes will be driven by people with lived experience. This project improves access to care for Black and Hispanic individuals in under-resourced settings by bringing integrated treatment of CP and OUD to them, and the interventions have high potential for dissemination and sustainability. An innovative program for pilot studies achieves a dual aim of catalyzing stakeholder-driven research and training early stage and new investigators. An exceptional team of investigators and clinical experts focused on CP and OUD, a longstanding history of collaboration with stakeholders and people with lived experience, and a high-impact population make Montefiore-Einstein an ideal site for an IMPOWR research center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older;
- •English or Spanish proficiency;
- •receiving BUP treatment for OUD for at least 14 days (thus a stabilized BUP dose); and
- •CP with at least moderate pain severity (score greater than or equal to 4 on Pain, Enjoyment of Life and General Activity (PEG) scale). Comorbid psychiatric conditions and use of psychotropic medications will be allowed
排除标准
- •Acute exacerbation of psychiatric conditions precluding the ability to participate in the study (e.g., acute mania, active suicidality/homicidality, psychosis);
- •psychotropic medication changes within the past three months prior to enrollment;
- •CP related to malignancy;
- •received ACT or similar therapeutic intervention in the past;
- •initiated psychotherapy within the past three months;
- •neurocognitive conditions that may prevent participants from accessing telehealth services;
- •current use of a smartphone health platform similar to the Valera app;
- •are unable or unwilling to provide signed consent for participation
研究组 & 干预措施
Valera smartphone application (app) alone
Participants randomized to this cohort will receive the Valera app and will receive a smartphone with network connectivity if necessary.
干预措施: Valera Smartphone Application (Other)
ACT + Valera app
Participants randomized to this cohort will receive both acceptance and commitment therapy (ACT) and the Valera app (and a smartphone with network connectivity if necessary).
干预措施: Acceptance and commitment therapy (Behavioral)
ACT + Valera app
Participants randomized to this cohort will receive both acceptance and commitment therapy (ACT) and the Valera app (and a smartphone with network connectivity if necessary).
干预措施: Valera Smartphone Application (Other)
treatment as usual (TAU)
Participants randomized to this cohort will not receive any experimental treatments.
干预措施: Treatment as Usual (Other)
结局指标
主要结局
Pain interference
时间窗: Baseline, 30 days, 12 weeks, 36 weeks
The primary outcome for pain will be pain-related functional interference, assessed with the Brief Pain Inventory (BPI), pain interference subscale, a nine-item measure that assesses pain related interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The total score has demonstrated reliability (e.g., Cronbach's Alpha = 0.86) and validity with chronic pain patients.
Opioid Use
时间窗: Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Opioid use will be measures by the Addiction Severity Index (ASI), which provides an assessment of drug use in the past 30 days, as done in our other studies.
Change in Pain Interference
时间窗: Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Change in Pain Interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associate with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Higher scores are indicative of more interference with daily life. Results will be summarized by study arm using basic descriptive statistics.
Illicit Opioid Use
时间窗: Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids or analgesics \[unprescribed\]. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.
次要结局
- Patient Report Outcome Measurement(Baseline, 12 weeks, 24 weeks, 36 weeks)
- Multidimensional Psychological Flexibility Inventory (MPFI)(Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- CHRONIC PAIN ACCEPTANCE QUESTIONNAIRE(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Trauma(Baseline and 24 weeks)
- AAQ-SA(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Mood Symptoms(Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Anxiety Symptoms(Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Pain catastrophizing(Baseline, 12 weeks, 36 weeks)
- Opioid craving(Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Substance Use(Baseline, 30 days, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Alcohol Use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Substance use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Sleep(Baseline, 12 weeks, 24 weeks, 36 weeks)
- Perceived Stress(Baseline, 12 weeks, 24 weeks, 36 weeks)
- Stress(Baseline and 24 weeks)
- Stigma & discrimination(Baseline)
- Suicidality(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Satisfaction with Therapy(12 weeks)
- Anhedonia(Baseline, 24 weeks, 36 weeks)
- Psychological Flexibility(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Psychological Inflexibility(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Psychological Flexibility Related to Substance Use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Committed Action(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Pain Acceptance(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Pain Catastrophizing(Baseline, 12 weeks, 36 weeks)
- Change in Pain Intensity(Baseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks)
- Heroin Use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Fentanyl Use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Unprescribed Prescription Opioid Analgesic Use(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Heatlh Related Quality of Life (HRQoL)(Baseline, 12 weeks, 24 weeks, and 36 weeks)
- Global Impression of Change(12 weeks and 36 weeks)
- Depressive Symptoms(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Anxiety Symptoms(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Positive Urine for Non-prescribed Opioids(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Psychiatric Diagnoses(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Retention with Buprenorphine(Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks)
- Satisfaction with ACT(12 weeks)
- Satisfaction with Valera(12 weeks)
- Valera Engagement with Articles(12 weeks)
- ACT Attendance(12 weeks)