Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to enroll 65 participants who will be assigned to one of two groups. Each group will receive an intervention consisting of six weekly sessions of 40-60 minutes each. Eligibility includes residing in an agricultural area and reporting loneliness or feeling alone or disconnected.
Individuals (n = 65) who reside in a agricultural area and report loneliness will be randomized to either (1) therapist-delivered cognitive-behavioral therapy for perceived social isolation, or (2) therapist-delivered Health Education. Loneliness, quantity of social interactions, perceived social support, substance use outcomes, and other key outcomes and descriptive characteristics will be assessed at baseline, mid-treatment, post-treatment, and at a one-month follow-up. Participants will have the option to complete daily ecological momentary assessments (EMA) 3 times a day for 7 weeks via an app on their smartphone, Catalyst by MetricWire, throughout the intervention period.
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive-Behavioral Therapy for Perceived Social Isolation | Behavioral | Consists of six 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 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 |
| 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 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
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicholas P Allan, PhD | Contact | 614-814-1299 | nicholas.allan@osumc.edu | |
| Sarah Millisor Irvin, MSc | Contact | 614-814-1318 | sarah.irvin@osumc.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Department of Psychiatry and Behavioral Health | Recruiting | Columbus | Ohio | 43210 | United States |
All de-identified demographic and clinical data collected as part of this project will be available as raw individual level data for sharing with external researchers working at an institution with a Federalwide Assurance (FWA) for the Protection of Human Subjects. Data will therefore be available for secondary analytic purposes. Names and institutions of persons either given or denied access to data will be tracked by our Administrative Core and will be available upon request from the sponsor. Data will not be available for data sharing until after this project is complete and the primary outcomes are published.
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for at least the next two years. Extensions will be considered on a case-by-case basis.
Access to trial individual participant data (IPD) can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
Not provided
Not provided
| ID | Term |
|---|---|
| D012934 | Social Isolation |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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. |
|
|