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

The Ohio State University

Status: Enrolling

Conditions: Loneliness; Social Isolation; Rural Health

Treatments: Behavioral: Health Education; Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT07218965

STUDY20250176

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Cognitive-Behavioral Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation

Therapist-delivered Health Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Health Education