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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06458335
Other study ID # STUDY00009396
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date June 30, 2029

Study information

Verified date June 2024
Source University of Rochester
Contact Lisham Ashrafioun, PhD
Phone 585-430-2026
Email lisham_ashrafioun@urmc.rochester.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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. We will assess 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 to see how well they work compared to each other.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 30, 2029
Est. primary completion date June 30, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

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
Health Education
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
University of Rochester Medical University of South Carolina, National Institute on Drug Abuse (NIDA), Ohio State University

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline to 6 months
Primary Mean change in number of days of opioid use Participants will complete a calendar indicating the type and frequency of drug use. Baseline to 6 months
Secondary 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. Baseline to 6 months
Secondary Mean change in depression Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. Baseline to 6 months
Secondary Mean change in anxiety Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome. Baseline to 6 months
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