Fostering Agricultural Relationships and Meaning - Thriving on Kinship
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
able to provide informed consent
understand English
have internet access
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive-Behavioral Therapy for Perceived Social Isolation
BehavioralConsists of six sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
Health Education
BehavioralHealth education provides information on the importance and benefits of and guidelines for living a health lifestyle.
Treatment groups
65 Participants
are divided into 2 treatment groupsGroup A: Cognitive-Behavioral TherapyExperimental treatment 1 intervention
Group B: Therapist-delivered Health EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 6 months2
Mean change in anxiety
Anxiety will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time frame
Baseline to 6 months3
Mean change in depression
Depression will be measured using the PROMIS tool. The scores range from 4-20 with higher scores indicating worse outcome.
Time frame
Baseline to 6 months4
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.
Time frame
Baseline to 6 monthsSponsors and contacts
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Source ClinicalTrials.gov