Decreasing Loneliness to Optimize Pain Care

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.

Conditions

• Loneliness
• Opioid Use

Interventions

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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Sebastian Tong, MD · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-09

Primary Completion

2025-12-18

Completion

2025-12-18

Countries

• United States

Study Locations