Loneliness(FARM-TOK)NCT07218965
Fostering Agricultural Relationships and Meaning - Thriving on Kinship
A study testing Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education in people with Loneliness and Social Isolation, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Loneliness, Social Isolation, Rural Health
- What is being tested?
- Cognitive-Behavioral Therapy for Perceived Social Isolation and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2025to Jul 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Department of Psychiatry and Behavioral Health
Columbus, Ohio, 43210
Nicholas Allan, PhD, 614-814-1299, nicholas.allan@osumc.edu
Sarah Millisor Irvin, MSc, 614-814-1318, sarah.irvin@osumc.edu
About this study
Official title: Fostering Agricultural Relationships and Meaning - Thriving on Kinship (FARM-TOK)
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.
Read the 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.
- Conditions
- Loneliness, Social Isolation, Rural Health
- Being tested
- Cognitive-Behavioral Therapy for Perceived Social Isolation, Health Education
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy for Perceived Social IsolationBehavioural
Also called CBT-PSI
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 EducationBehavioural
Also called HET
Health education provides information on the importance and benefits of and guidelines for living a health lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-Behavioral Therapy | Experimental | CBT delivered over the course of 6, ~45 minute sessions delivered via telehealth Receives: Behavioral: Cognitive-Behavioral Therapy for Perceived Social Isolation |
| Therapist-delivered Health Education | Active comparator | Health education sessions delivered over the course of 6, ~45 minute sessions delivered via telehealth. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start26 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Allan, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218965
- Sponsor's protocol ID
- STUDY20250176
- Acronym
- (FARM-TOK)
- Status last verified
- Oct 2025
- First submitted
- 17 Oct 2025
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.