Decreasing Loneliness to Optimize Pain Care

Not Applicable

• Conditions: Loneliness; Opioid Use
• Interventions: Behavioral: Social Navigation Group; Behavioral: Cognitive Behavior Therapy (CBT); Behavioral: Controlled Group

• Registration Number: NCT06285032
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-29
• Status Verified: 2024-08
• Study Start: 2024-08-09
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• 18 years or older
• English-speaking
• On chronic opioids (defined as defined as 3 or more months receiving prescribed opioids [functional definition is 3 or more opioid prescriptions each less than 21 days apart as per our prior studies])
• With a score greater or equal to 6 on the UCLA Loneliness 3-item Scale
• Have a chronic pain diagnosis

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Exclusion Criteria

• Have cancer-related pain
• Are on palliative care or live in a controlled setting (i.e., assisted living, nursing home or inpatient treatment facility)
• Have an upcoming scheduled surgery
• Severe cognitive impairment or active psychosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Social Navigation Group	Social Navigation Group	Participants will be randomized to the social navigation group (N=34). Social navigation group will meet for 30 mins via Zoom, for 8 weeks.
Cognitive Behavioral Therapy (CBT)	Cognitive Behavior Therapy (CBT)	Participants will be randomized to the CBT group (N=34). CBT groups will meet for 1 hour via Zoom, for 8 weeks.
Usual Care Group	Controlled Group	Participants will be randomized to the usual care group (N=34). Participants in this group will resume to their usual standard of care for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Opioid Misuse	Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.	The primary outcome is to see changes in opioid misuse, which the investigators will measure using the Current Opioid Misuse Measure (COMM). The investigators will give the COMM at baseline, post-intervention (2 weeks after intervention completion), and 3 months after the intervention has been completed to find out changes in behaviors. Those with a score of 9 or greater are consider positive for misuse (min=0, max score=68).

Secondary Outcome Measures

Name	Time	Method
Determine Functional Outcome	Baseline, post-intervention (2 weeks after the completion of the intervention), and month 3 after completed intervention.	The investigators will use the Patient Reported Outcomes Measurement Information (PROMIS) pain interference (version 6b) to measure changes in functionality. Investigators will interpret data from the survey and look at participants who indicate any amount of pain (min=0, max score=30). The PROMIS scale is used to track pain interference, especially for those who frequently struggle with chronic pain and therefore, are on chronic opioids.

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States