Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine

Официальное название

Improving Pain and Functioning Using an Integrative Digital Treatment for Chronic Pain and Addiction in Veterans With Opioid Use Disorder Receiving Buprenorphine

Обзор

Chronic pain is common in individuals with opioid use disorder (OUD) and the first-line treatment, Medication for OUD (MOUD), does not address the considerable functional impairments associated with chronic pain. Veterans with OUD and chronic pain could benefit from integrated, behavioral treatment for chronic pain and addiction, but VHA MOUD clinics often lack the resources to offer these services. The proposed study will examine the effectiveness of an evidence-based digital chronic pain and addiction treatment that Veterans can do from home, which can provide a flexible option for Veterans to engage in treatment from home and the Veterans Health Administration (VHA) a means to provide care without placing trained clinicians at each facility.

Подробное описание

The Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) is a 9-week, web-based treatment supplemented with daily digital surveys that inform personalized weekly feedback messages for people with chronic pain and OUD receiving MOUD. IMPACT is an integration of two previously tested technology-based interventions developed in a prior NIH-funded trial. Typically, VHA pain treatment resources are greater than civilian healthcare settings; therefore, the comparator group (enhanced treatment as usual or ETAU) in the current trial is a necessary step to rigorously test IMPACT specifically within Veteran Health Administration (VHA) clinical care.

Вмешательства

• Поведенческое Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)
  The IMPACT program is a 9-module web-based treatment augmented with personalized weekly feedback from an expert coach for people with chronic pain and OUD receiving MOUD.
• Поведенческое Enhanced Treatment as Usual (ETAU)
  ETAU is inclusive of medication management, groups, and individual treatment offered within the outpatient buprenorphine clinics at the study sites. Additionally, study staff will provide a a comprehensive list of pain, addiction and mental health treatment options that are specific to their VA facility.

Первичные конечные точки

• PROMIS Pain Interference 6b [Срок оценки: 3-months post-randomization]

Вторичные конечные точки (7)

• PROMIS Pain Interference 6b [Срок оценки: 6- and 9-months post randomization]
• Veterans Rand 12-Item Health Survey (VR-12) [Срок оценки: 3-months post-randomization]
• Activity Measure for Post-Acute Care (AM-PAC) [Срок оценки: 3-months post-randomization]
• PROMIS Sleep Disturbance 6a and Duration [Срок оценки: 3-months post randomization]
• Buprenorphine retention [Срок оценки: 3-months post randomization]
• Buprenorphine adherence [Срок оценки: 3-months post randomization]
• Non-prescribed opiate use [Срок оценки: 3-months post randomization]

Критерии участия

Критерии включения

• an ICD-11 OUD diagnosis in the VHA electronic health record (EHR)
• receipt of buprenorphine from outpatient addiction clinic with stable (i.e., unchanged in 2 weeks or since last injection) dose confirmed by the prescribing clinician. Both oral and injectable buprenorphine formulations will be eligible with dose stabilization required to isolate chronic pain from withdrawal-related pain associated with non-therapeutic dose
• presence of musculoskeletal pain that is bothersome or high-impact per the Graded Pain Scale - Revised
• access to a web-connected device to complete daily surveys and connect to IMPACT treatment site
• ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block

Критерии исключения

• dementia-related EHR diagnosis
• participant-reported vision or hearing impairments that would preclude use of the IMPACT system
• legal actions that would make study completion unlikely
• current or past 12 month engagement in CBT for chronic pain treatment
• planned surgical intervention for pain
• physical or mental health conditions that would interfere with ability to meaningful engage in IMPACT and MOUD treatment (e.g., uncontrolled bipolar disorder, active suicidal ideation, receipt of hospice or end-of-life palliative care)

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

Лечение

Центры проведения

США · 4 центра

• VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
• VA Bedford HealthCare System, Bedford, MA — Bedford
• VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
• VA Portland Health Care System, Portland, OR — Portland

Идентификаторы

NCT: NCT07361432 · RRDA-001-25M · 1I01RD000376-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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