Opioids and Loneliness

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Loneliness; Social Isolation
• Interventions: Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation; Behavioral: Health Education

• Registration Number: NCT06458335
• Lead Sponsor: University of Rochester

Brief Summary

This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.

Detailed Description

Individuals (n = 300) with an opioid use disorder reporting loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, (2) therapist-delivered Health Education, or (3) self-guided Health Education. Loneliness, opioid and other substance use, the amount of social interactions, social support, and mental and physical health factors prior to starting the treatment, after completing the treatment, and 1, 3, and 6 months following the treatment will be assessed to see how well they work compared to each other.

Study Timeline

• Study First Submitted: 2024-06-09
• Study First Submitted QC: 2024-06-09
• Study First Posted: 2024-06-13
• Study Start: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11
• Primary Completion: 2029-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Must be 18+
• understand English -have internet access-
• screen positive for an opioid use disorder
• screen positive for elevated loneliness

Exclusion Criteria

• does not understand consent
• does not have consistent access to a phone and internet

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioral Therapy	Cognitive-Behavioral Therapy for Perceived Social Isolation	CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth
therapist-delivered Health Education	Health Education	Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
self-guided Health Education	Health Education	Health education sessions that are self-guided over the course of 6 sessions

Primary Outcome Measures

Name	Time	Method
Mean change in loneliness	Baseline to 6 months	Loneliness will be measured using the UCLA Loneliness Scale. A 20-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each item as 1 (never), 2 (rarely), 3 (sometimes) or 4 (often). The scores range from 20-80 with higher scores indicating worse outcome.
Mean change in number of days of opioid use	Baseline to 6 months	Participants will complete a calendar indicating the type and frequency of drug use.

Secondary Outcome Measures

Name	Time	Method
mean change in social interactions	Baseline to 6 months	Duke Social Support Index assesses several domains of perceived social support, including social network size, social interaction, social satisfaction, and instrumental social support. Higher scores indicate a higher quality of social interactions. Scores range from 0 to 37.
Mean change in depression	Baseline to 6 months	Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in anxiety	Baseline to 6 months	Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States