Decreasing Loneliness to Optimize Pain Care (DLoop)

University of Washington

Status: Completed

Conditions: Loneliness; Opioid Use

Treatments: Behavioral: Social Navigation Group; Behavioral: Cognitive Behavior Therapy (CBT); Behavioral: Controlled Group

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06285032

R34DA058325 (U.S. NIH Grant/Contract)

STUDY00017244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 3 patient groups

Cognitive Behavioral Therapy (CBT)

Experimental group

Description:

Participants will be randomized to the CBT group (N=34). CBT groups will meet for 1 hour via Zoom, for 8 weeks.

Treatment:

Behavioral: Cognitive Behavior Therapy (CBT)

Social Navigation Group

Experimental group

Description:

Participants will be randomized to the social navigation group (N=34). Social navigation group will meet for 30 mins via Zoom, for 8 weeks.

Treatment:

Behavioral: Social Navigation Group

Usual Care Group

Experimental group

Description:

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.

Treatment:

Behavioral: Controlled Group