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Fostering Agricultural Relationships and Meaning - Thriving on Kinship

Fostering Agricultural Relationships and Meaning - Thriving on Kinship (FARM-TOK)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07218965
Acronym
(FARM-TOK)
Enrollment
65
Registered
2025-10-21
Start date
2025-07-26
Completion date
2026-07-31
Last updated
2025-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Loneliness, Rural Health, Social Isolation

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.

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.

BEHAVIORALHealth Education

Health education provides information on the importance and benefits of and guidelines for living a health lifestyle.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean change in lonelinessBaseline to 6 monthsLoneliness 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 anxietyBaseline to 6 monthsAnxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in depressionBaseline to 6 monthsDepression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Mean change in social interactionsBaseline to 6 monthsDuke 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.

Countries

United States

Contacts

Primary ContactNicholas P Allan, PhD
nicholas.allan@osumc.edu614-814-1299
Backup ContactSarah Millisor Irvin, MSc
sarah.irvin@osumc.edu614-814-1318

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026