Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT07218965

Conditions

Loneliness

Social Isolation

Rural Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioral Therapy for Perceived Social Isolation

Health Education

Study Details

Brief summary:

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.

Conditions

Loneliness

Social Isolation

Rural Health

Study ID

NCT07218965

Start date

Jul 26, 2025

Status verified date

Oct, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years of age or older
  • able to provide informed consent
  • understand English
  • have internet access
  • reside in an agricultural area
  • screen positive for loneliness by scoring at least 44 on the 20-item UCLA Loneliness Scale

Exclusion Criteria:

  • unable to give informed consent
  • non-English speaking
  • does not have consistent access to a phone and/or internet
  • reports being diagnosed with a neurological disorder or a current psychotic or bipolar 1 diagnosis
  • current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer

Study Design

Enrollment

65 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive-Behavioral Therapy

CBT delivered over the course of 6, \~45 minute sessions delivered via telehealth

active comparator: Therapist-delivered Health Education

Health education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.

Interventions

Cognitive-Behavioral Therapy for Perceived Social Isolation

Consists of six 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.

Primary outcome measure

  • Mean change in loneliness [ Time Frame: Baseline to 6 months ]
  • Mean change in anxiety [ Time Frame: Baseline to 6 months ]
  • Mean change in depression [ Time Frame: Baseline to 6 months ]
  • Mean change in social interactions [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Nicholas P Allan, PhD

614-814-1299nicholas.allan@osumc.edu

Sarah Millisor Irvin, MSc

614-814-1318sarah.irvin@osumc.edu

Locations

The Ohio State University Department of Psychiatry and Behavioral Health

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Nicholas Allan, PhD

614-814-1299nicholas.allan@osumc.edu

Sarah Millisor Irvin, MSc

614-814-1318sarah.irvin@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Oct 21, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2025-10-21.