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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Cognitive-Behavioral Therapy 		CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth
  • Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation
    6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use
    Other names:
    • CBT-PSI
Active Comparator
therapist-delivered Health Education 		Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth.
  • Behavioral: Health Education
    Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
Active Comparator
self-guided Health Education 		Health education sessions that are self-guided over the course of 6 sessions
  • Behavioral: Health Education
    Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Recruiting Locations

University of Rochester
Rochester 5134086, New York 5128638 14642
Contact:
Lisham Ashrafioun, PhD
585-430-2026

More Details

Status
Recruiting
Sponsor
University of Rochester

Study Contact

Lisham Ashrafioun, PhD
585-430-2026
lisham_ashrafioun@urmc.rochester.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.