NCT06285032

Decreasing Loneliness to Optimize Pain Care

Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Loneliness, which is the perceived feeling of insufficient personal relationships, is related to higher risk for inappropriate opioid use and opioid use disorders in patients who are taking opioids long-term. The study seeks to pilot test the evidence-based loneliness interventions of psychological therapy and social navigation in patients on chronic opioids treated in primary care practices to determine if reducing loneliness can lower opioid misuse.

Detailed description

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 the study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care with 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. Aims * To refine both the social navigation and psychological CBT loneliness interventions for patients in primary care on chronic opioids * To assess the feasibility of implementing a 3-arm pilot randomized clinical effectiveness trial testing a psychological CBT and a social navigation intervention to address loneliness in primary care patients. * 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 outcomes in the pilot randomized clinical effectiveness trial.

Conditions

• Loneliness
• Opioid Use

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavior Therapy (CBT)	Individuals will participate in a series of eight, 1hour weekly group sessions delivered by a study interventionalist who is a licensed social worker (see personnel list) using a HIPAA-compliant videoconferencing platform (Zoom). Each group will consist of 6-10 participants and participants randomized to this intervention will select between a series of date/time options. The investigators plan to run four groups with staggered start times. All participants will receive digital copies of the workbook for this intervention and each session, they will be given assignments to practice the strategies they learn during the intervention.
BEHAVIORAL	Social Navigation Group	Those in the social navigation intervention, will meet with a navigator weekly through a virtual visit (HIPAA-compliant videoconferencing or phone call based on patient preference) over the course of 8 weeks. Each virtual visit will last approximately 30 minutes with a longer initial intake visit lasting 60 minutes. During the intake visit, the navigator will complete a patient narrative and an inventory of the patient's existing social network, former social network and interests. Using this, the navigator will work with the patient to develop an action plan to promote, establish or re-establish social connections. The action plan will be referenced and refined throughout the course of the 8 weeks. They will suggest specific social activities and connect patients to resources such as, community-based organizations or local social groups matched to individual participant interest to assist with social connection
BEHAVIORAL	Controlled Group	Those randomized to the control group will receive usual care from their primary care clinician. At the conclusion of the study (after the final outcomes are collected), they will be offered a list of possible community-based organizations for social connection.

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-12-18
• Completion: 2025-12-18
• First posted: 2024-02-29
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States