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NCT Number: NCT07218965

Fostering Agricultural Relationships and Meaning - Thriving on Kinship

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.

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Key information

Conditions

Loneliness Behavior Rural Health Social Behavior Social Isolation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy for Perceived Social Isolation

Behavioral

Consists of six sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.

Other names: CBT-PSI

Health Education

Behavioral

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

Other names: HET

Primary outcomes

  1. Mean change in loneliness

    Time frame: 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.

  2. Mean change in anxiety

    Time frame: Baseline to 6 months

    Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

  3. Mean change in depression

    Time frame: Baseline to 6 months

    Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.

  4. Mean change in social interactions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicholas P Allan, PhD

CONTACT

[email protected]

614-814-1299

Sarah Millisor Irvin, MSc

CONTACT

[email protected]

614-814-1318

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Acronym: (FARM-TOK)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2025
Registry last updated
Oct 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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