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Talking away loneliness: new study tests short therapy for rural isolation

NCT ID NCT07218965

Symptom relief Sponsor: Ohio State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a 6-session therapy program (CBT-PSI) can reduce loneliness and improve mental health in adults living in agricultural areas. 65 participants will be assigned to either the therapy or a health education group. The goal is to see if changing thoughts and behaviors around social isolation can ease loneliness, anxiety, and depression.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive-Behavioral Therapy for Perceived Social Isolation (CBT-PSI)
What this could lead to
If it works, this could point toward a practical, short-term therapy to ease loneliness and related anxiety or depression in rural communities.
What could go wrong
This is a small, early-stage study with only 65 participants, so results may not apply broadly. The therapy is behavioral, not a drug, and benefits may be modest or temporary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Social Isolation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Loneliness Rural health Social isolation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Ohio State University Department of Psychiatry and Behavioral Health

    RECRUITING

    Columbus, Ohio, 43210, United States

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