An interventional study of Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education in Loneliness, Social Isolation and Rural Health, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
Among 97 studies in Social Isolation with a site in United States — 26 open to participants now, 29 under way, none of them phase 3. Social Isolation · United States.
Among the 97 studies in Social Isolation with a site in United States, this one is the 74th largest by enrollment of the 92 interventional ones that give a count, is one of 9 that started in 2025, is one of 89 with no phase, and was the 88th registered.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's enrollment of 31 is below the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →26 of the 97 studies in Social Isolation with a site in United States are open now, in 4 countries. Each count lists the studies.
Of the 34 Social Isolation studies recruiting now, 22 (65%) set no upper age limit and 6 (18%) stop at 75 or younger; 4 take children under 18; 18 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →97 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 9 started in 2025.
Median enrollment 79 across the 92 interventional studies, 650 across the 5 observational. Of the 65 that completed or were terminated, 22 (34%) have results posted.
1 of 97 have an industry lead sponsor. The 10 most frequent:
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Ohio State University has 1 study filed under Social Isolation — fewer than ten, so there is no comparison to draw.
8 of the studies in Social Isolation with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06721559University of MichiganEmpower@Home: Community Implementation for Older Adults With Ambulatory Disabilities | 2026-12 |
| NCT04391816National Institute on Alcohol Abuse and Alcoholism (NIAAA)COVID-19 Pandemic Impact on Alcohol (PIA) - A Natural History Study | 2026-12-31 |
| NCT06817993University of PittsburghTeen Brain Online II: Understanding How Social Media Affects the Teen Brain | 2027-03-30 |
| NCT07863583Johns Hopkins UniversitySocial Connection Collective for Older Adults in Subsidized Housing | 2027-04 |
| NCT07123298Johns Hopkins UniversityCAPABLE Care + Connect | 2027-05 |
Among the 97 studies in Social Isolation with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth
Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation
Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Behavioral: Health Education
Consists of six sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
Also known as: CBT-PSI
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle.
Also known as: HET
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Plan to share: Yes — 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.
Supporting information: Study protocol
Time frame: 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 criteria: 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).
No publications or documents are linked to this record.
Ran from Jul 2025 to primary completion in Sep 2026, 13 months.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's 13 months is below that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 4, 2026: primary completion Jul 2026 → Sep 2026 and completion Jul 2026 → Sep 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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