An interventional study of Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education in Opioid Use Disorder, Loneliness and Social Isolation, sponsored by University of Rochester. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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.
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.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 300 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →University of Rochester is the lead sponsor of 729 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth
Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Behavioral: Health Education
Health education sessions that are self-guided over the course of 6 sessions
Behavioral: Health Education
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use
Also known as: CBT-PSI
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
Mean change in loneliness
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.
Time frame: Baseline to 6 months
Mean change in number of days of opioid use
Participants will complete a calendar indicating the type and frequency of drug use.
Time frame: Baseline to 6 months
mean change in social interactions
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.
Time frame: Baseline to 6 months
Mean change in depression
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time frame: Baseline to 6 months
Mean change in anxiety
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time frame: Baseline to 6 months
Plan to share: Yes — De-identified participant data is available upon request through a data use agreement as part of scientific collaboration
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jun 2029, 57 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 57 months is above that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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