Loneliness, Opioid Use Disorder, Social Isolation
Conditions
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.
Interventions
6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use
BEHAVIORALHealth Education
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle
Sponsors
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Ohio State University
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactLisham Ashrafioun, PhD
Outcome results
None listed