About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
an ICD-11 opioid use disorder (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 Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) treatment site
Disqualifiers
dementia-related electronic health record (EHR) diagnosis
participant-reported vision or hearing impairments that would preclude use of the Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) system
legal actions that would make study completion unlikely
current or past 12 month engagement in CBT for chronic pain treatment
Trial design
Parallel
Treatments tested in this trial
Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT)
BehavioralThe 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.
Enhanced Treatment as Usual (ETAU)
BehavioralETAU 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.
Treatment groups
Trial outcomes
Primary outcomes
PROMIS Pain Interference 6b
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to less pain interference).
Secondary outcomes
PROMIS Pain Interference 6b
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less pain interference).
Veterans Rand 12-Item Health Survey (VR-12)
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower corresponds to better quality of life).
Activity Measure for Post-Acute Care (AM-PAC)
Measure has two scales: Basic Mobility (range: 0-24) and Daily Activity (range: 0-24); on both scales higher scores corresponds to better performance.
PROMIS Sleep Disturbance 6a and Duration
T-score will be calculated from raw scores with a mean of 50 and standard deviation of 10 (lower score corresponds to less sleep disturbance).
Sponsors and contacts
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