Fostering Agricultural Relationships and Meaning - Thriving on Kinship

Not Applicable

Recruiting

• Conditions: Loneliness; Social Isolation; Rural Health

• Registration Number: NCT07218965
• Lead Sponsor: Ohio State University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-07-26
• Status Verified: 2025-10
• Study First Submitted: 2025-10-17
• Study First Submitted QC: 2025-10-17
• Last Update Submitted: 2025-10-17
• Study First Posted: 2025-10-21
• Last Update Posted: 2025-10-21
• Primary Completion: 2026-07
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.
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.
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 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.

Trial Locations

Locations (1)

The Ohio State University Department of Psychiatry and Behavioral Health; 🇺🇸 Columbus, Ohio, United States