NCT04938492

The Association Between Loneliness and Substance Use

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will determine if cognitive behavioral therapy will help improve loneliness in people who use opioids.

Detailed description

The proposed study will be the first to assess the cognitive, affective, and behavioral pathways by which loneliness impacts opioid use. Individuals with an opioid use disorder (OUD) reporting loneliness will be randomized to either a 6-session Cognitive- Behavioral Therapy for loneliness (CBT-L) or a 6-session education control condition, both delivered via telehealth. Telehealth delivery can be easily implemented and can increase reach and access to individuals not engaged in treatment. We will use an established brief CBT manual to address loneliness. We will assess loneliness, negative affect (i.e., depression and anxiety), and the quality and quantity of social interactions prior to, during, and after the intervention to evaluate the subsequent impact on opioid use trajectories. Participant will complete questionnaires pre-treatment, post-treatment, and at 1- and 2-months posttreatment.

Conditions

• Opioid Use
• Loneliness

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioral Therapy for loneliness (CBT-L)	6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
BEHAVIORAL	Physical Health Education Training (PHET)	Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.

Timeline

• Start date: 2021-08-12
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2021-06-24
• Last updated: 2025-02-11
• Results posted: 2025-01-29

Locations

1 site across 1 country: United States