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Principal Investigator: Sebastian Tong
Organization: UNIVERSITY OF WASHINGTON
Fiscal Year: 2024
Award: $272,125
Funding agency: National Institute on Drug Abuse
PROJECT SUMMARY
Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer
health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids
are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce
loneliness in primary care patients at risk for opioid misuse. The long-term goal of our study is to reduce opioid
misuse and opioid use disorder by addressing loneliness in primary care patients on chronic opioids.
Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving
social support through social navigation have been shown to be effective in reducing loneliness and improving
outcomes in other fields but have not been tested in patients at risk for substance use disorder.
In our study, which responds to RFA-DA-23-010 (Enhancing Social Connectedness and Ameliorating
Loneliness to Prevent and Treat SUD and Support Recovery), we propose a pilot 3-arm randomized clinical
effectiveness trial that will adapt and test the feasibility of implementing two efficacious interventions: (1) a
psychological intervention using cognitive behavioral therapy to address maladaptive thought patterns around
social connection and (2) a social navigation intervention to connect participants with social opportunities and
develop supportive social networks. Our proposed study would take place in primary care practices from the
Washington, Wyoming, Alaska, Montana and Idaho region Practice and Research Network, a practice-based
research network of over 100 practices. Our specific aims are: (1) to refine and adapt both the social
navigation and psychological loneliness interventions for primary care patients on chronic opioids by engaging
patients and clinicians in a series of stakeholder group meetings, (2) to assess the feasibility of implementing a
3-arm randomized clinical effectiveness trial with 102 patients using the RE-AIM framework, and (3) to
determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid
misuse) and secondary outcomes including opioid dose, functional status and patient-reported pain at three
time points -- baseline, post-intervention and 3 months post-intervention.
Our study is innovative because we are testing evidence-based interventions for loneliness in patients
at high risk for opioid misuse where they are already receiving care and where most patients with chronic pain
receive their pain related care. We expect that, consistent with the purpose of the R34 mechanism, this project
will prepare us for larger scale pragmatic trial, where we can leverage embedded or remote behavioral health
professionals within a diverse set of primary care practices, that tests patient outcomes, clinic-level feasibility,
and sustainability. The project is expected to have a positive impact in reducing opioid misuse and potentially
development of substance use disorder, as well as improve health outcomes, functionality, and quality of life.
Terms: <Address><Alaska><Behavior><COVID crisis><COVID epidemic><COVID pandemic><COVID-19 crisis><COVID-19 epidemic><COVID-19 era><COVID-19 global health crisis><COVID-19 global pandemic><COVID-19 health crisis><COVID-19 pandemic><COVID-19 period><COVID-19 public health crisis><COVID-19 years><Caring><Chronic><Clinic><Cognition Therapy><Cognitive Psychotherapy><Cognitive Therapy><Cognitive treatment><Data><Development><Dose><Ethnic Origin><Ethnicity><Evidence based intervention><Feeling><Future><Gender><Geographic Area><Geographic Locations><Geographic Region><Geographical Location><Goals><Group Meetings><Health><Health Care Professional><Health Professional><Healthcare professional><Idaho><Intervention><Intervention Strategies><Loneliness><Measures><Mediating><Montana><Opiates><Opioid><Outcome><Pain><Pain interference><Painful><Participant><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Pattern><Perception><Population><Primary Care><QOL><Quality of life><RE-AIM><Race><Races><Randomized><Reach, Effectiveness, Adoption, Implementation, and Maintenance><Recovery Support><Reporting><Research><Risk><SARS-CoV-2 epidemic><SARS-CoV-2 global health crisis><SARS-CoV-2 global pandemic><SARS-CoV-2 pandemic><SARS-coronavirus-2 epidemic><SARS-coronavirus-2 pandemic><Series><Severe Acute Respiratory Syndrome CoV 2 epidemic><Severe Acute Respiratory Syndrome CoV 2 pandemic><Severe acute respiratory syndrome coronavirus 2 epidemic><Severe acute respiratory syndrome coronavirus 2 pandemic><Social Network><Social support><Substance Use Disorder><System><Testing><Therapeutic Intervention><Time><Washington><Wyoming><arm><behavioral health><care as usual><care seeking><chronic pain patient><cognitive behavior intervention><cognitive behavior modification><cognitive behavior therapy><cognitive behavioral intervention><cognitive behavioral modification><cognitive behavioral therapy><cognitive behavioral treatment><coronavirus disease 2019 crisis><coronavirus disease 2019 epidemic><coronavirus disease 2019 global health crisis><coronavirus disease 2019 global pandemic><coronavirus disease 2019 health crisis><coronavirus disease 2019 pandemic><coronavirus disease 2019 public health crisis><coronavirus disease crisis><coronavirus disease epidemic><coronavirus disease pandemic><coronavirus disease-19 global pandemic><coronavirus disease-19 pandemic><developmental><effectiveness clinical trial><efficacious intervention><evidence base><experience><feasibility testing><feelings><functional status><geographic site><high risk><implementation outcomes><improved><improved outcome><innovate><innovation><innovative><interpersonal competence><interpersonal competency><intervention therapy><interventional strategy><licit opioid><lonely><non-medical opioid use><nonmedical opioid use><opiate consumption><opiate drug use><opiate intake><opiate medication><opiate misuse><opiate use><opiate use disorder><opioid consumption><opioid drug use><opioid intake><opioid medication><opioid misuse><opioid use><opioid use disorder><pain outcome><pain-related outcome><participant engagement><patient engagement><patient oriented outcomes><patient population><patient with chronic pain><pilot test><pilot trial><poor health outcome><post intervention><practice-based research network><pragmatic effectiveness trial><pragmatic trial><prescribed opiate><prescribed opioid><prescription opiate><prescription opioid><prevent><preventing><primary care clinician><primary care patient><primary care practice><primary care setting><primary outcome><psychologic><psychological><racial><racial background><racial origin><randomisation><randomization><randomly assigned><reach, efficacy, adoption, implementation, and maintenance><reduced health outcome><secondary outcome><severe acute respiratory syndrome coronavirus 2 global health crisis><severe acute respiratory syndrome coronavirus 2 global pandemic><social><social cognition><social competence><social competency><social skills><social support network><substance use and disorder><treatment as usual><usual care><worse health outcome>