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Recruiting NCT07218965

Fostering Agricultural Relationships and Meaning - Thriving on Kinship

No phase Interventional Loneliness Social Isolation Rural Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive-Behavioral Therapy for Perceived Social Isolation, Health Education.
Who it may be relevant to
Registry conditions: Loneliness, Social Isolation, Rural Health. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral Cognitive-Behavioral Therapy for Perceived Social Isolation
    Consists of six sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
  • Behavioral Health Education
    Health education provides information on the importance and benefits of and guidelines for living a health lifestyle.

Primary outcome measures

  • Mean change in loneliness [Time frame: Baseline to 6 months]
  • Mean change in anxiety [Time frame: Baseline to 6 months]
  • Mean change in depression [Time frame: Baseline to 6 months]
  • Mean change in social interactions [Time frame: Baseline to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • The Ohio State University Department of Psychiatry and Behavioral Health — Columbus

Identifiers

NCT: NCT07218965 · STUDY20250176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗