Fostering Agricultural Relationships and Meaning - Thriving on Kinship
(FARM-TOK)
1 other identifier
interventional
65
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2025
CompletedFirst Submitted
Initial submission to the registry
October 17, 2025
CompletedFirst Posted
Study publicly available on registry
October 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
October 21, 2025
October 1, 2025
11 months
October 17, 2025
October 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Cognitive-Behavioral Therapy
EXPERIMENTALCBT delivered over the course of 6, \~45 minute sessions delivered via telehealth
Therapist-delivered Health Education
ACTIVE COMPARATORHealth education sessions delivered over the course of 6, \~45 minute sessions delivered via telehealth.
Interventions
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 provides information on the importance and benefits of and guidelines for living a health lifestyle.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 17, 2025
First Posted
October 21, 2025
Study Start
July 26, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
October 21, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- 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).
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.