Fostering Agricultural Relationships and Meaning - Thriving on Kinship

NCT ID: NCT07218965

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-26

Study Completion Date

2026-07-31

Brief Summary

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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

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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

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Loneliness Social Isolation Rural Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Cognitive-Behavioral Therapy

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

Group Type EXPERIMENTAL

Cognitive-Behavioral Therapy for Perceived Social Isolation

Intervention Type 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.

Therapist-delivered Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Health Education

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-PSI HET

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Nicholas Allan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University Department of Psychiatry and Behavioral Health

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicholas P Allan, PhD

Role: CONTACT

614-814-1299

Sarah Millisor Irvin, MSc

Role: CONTACT

614-814-1318

Facility Contacts

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Nicholas Allan, PhD

Role: primary

614-814-1299

Sarah Millisor Irvin, MSc

Role: backup

614-814-1318

Other Identifiers

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STUDY20250176

Identifier Type: -

Identifier Source: org_study_id

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