Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA060966 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Medical University of South Carolina | OTHER |
| Ohio State University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth |
|
| therapist-delivered Health Education | Active Comparator | Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. |
|
| self-guided Health Education | Active Comparator | Health education sessions that are self-guided over the course of 6 sessions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Perceived Social Isolation | Behavioral | 6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisham Ashrafioun, PhD | Contact | 585-430-2026 | lisham_ashrafioun@urmc.rochester.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Recruiting | Rochester | New York | 14642 | United States |
De-identified participant data is available upon request through a data use agreement as part of scientific collaboration
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Health Education | Behavioral | Health education provides information on the importance and benefits of and guidelines for living a health lifestyle |
|
| 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 |
| 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 |
| D012919 | Social Behavior |
| D001519 | Behavior |