Cognitive Behavioral Therapy for Social Isolation

((FARM-TOK) Trial)

Overseen By Sarah Millisor Irvin, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Neurological disorder, Psychotic, Bipolar 1, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two approaches to help people who feel lonely or disconnected, especially in agricultural areas. One group receives Cognitive-Behavioral Therapy (CBT), which uses talking therapies to change thought patterns, while the other group receives health education sessions. Both methods aim to reduce loneliness over six weekly sessions delivered via telehealth. Individuals who feel isolated, live in rural areas, and have internet access might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore effective ways to combat loneliness in rural communities.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive-Behavioral Therapy (CBT) safely and effectively reduces feelings of loneliness and social isolation. Studies have found that CBT can lower loneliness and symptoms of depression. Participants generally tolerate it well, with no major safety issues reported.

Past studies offered CBT through online sessions, which also proved effective. This method makes therapy more accessible by eliminating the need to travel. The therapy sessions focus on changing thoughts and actions, improving mood, and lessening loneliness.

Overall, CBT is a promising option for those feeling isolated, with a strong record of safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cognitive Behavioral Therapy (CBT) for perceived social isolation because it offers a structured approach to addressing feelings of loneliness through telehealth. Unlike traditional in-person therapy or medication, this method involves engaging, guided sessions that individuals can access from the comfort of their home, which can be particularly appealing for those who feel isolated. Additionally, the use of telehealth makes the treatment more accessible to a broader audience, potentially reducing barriers like travel and scheduling, which are often limitations of standard care. This innovative delivery method opens up new possibilities for effective mental health support, allowing researchers to explore how a virtual format can impact treatment outcomes.

What evidence suggests that this trial's treatments could be effective for social isolation?

Studies have shown that Cognitive-Behavioral Therapy (CBT) effectively reduces feelings of loneliness, especially among older adults. In this trial, participants will receive CBT through six approximately 45-minute telehealth sessions. Research indicates that shorter, group-based sessions, like those in this trial, often have stronger effects. Online CBT, similar to the format offered in this study, has also been found to help reduce social isolation. This therapy changes negative thought patterns and encourages positive social interactions. Overall, CBT offers a promising approach for those feeling disconnected or alone. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who feel lonely or disconnected, live in agricultural areas, and have internet access. They must understand English and score at least 44 on the UCLA Loneliness Scale. People with certain neurological disorders, current severe mental health conditions, or without consistent phone/internet can't join.

Inclusion Criteria

I am 18 years old or older.

Able to provide informed consent

Understand English

Exclusion Criteria

Non-English speaking

Does not have consistent access to a phone and/or internet

I have been diagnosed with a neurological disorder or bipolar 1.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cognitive-behavioral therapy or health education over six weekly sessions

6 weeks

6 sessions (telehealth)

Ecological Momentary Assessment

Participants complete daily assessments via an app 3 times a day for 7 weeks

7 weeks

Follow-up

Participants are monitored for changes in loneliness, anxiety, depression, and social interactions

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive-Behavioral Therapy for Perceived Social Isolation
• Health Education

Trial Overview The study tests two interventions to combat loneliness: Health Education and Cognitive-Behavioral Therapy (CBT). Participants will be randomly placed into groups receiving one of these treatments through weekly online sessions lasting between 40-60 minutes each.

How Is the Trial Designed?

Group I: Cognitive-Behavioral Therapy Experimental Treatment 1 Intervention

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

Group II: Therapist-delivered Health Education Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Citations

1. psycnet.apa.org psycnet.apa.org/record/2026-78292-002

Exploring the influence of loneliness and social isolation in ... Exploring the influence of loneliness and social isolation in transdiagnostic internet-delivered cognitive behavioral therapy for depression and anxiety.

2. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1433108/full

Developing a brief telematic cognitive behavioral therapy ... The present study aims to present a novel cognitive-behavioral intervention protocol focused on treating social isolation through telematic interaction.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9811092/

Can we mitigate the psychological impacts of social ... Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0167494325003103

Review The Effectiveness of Cognitive Behavioral Therapy ... CBT shows exploratory evidence of reducing loneliness among older adults. · Shorter durations and group formats showed stronger effects. · Online ...

5. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2797399

Interventions Associated With Reduced Loneliness and ... This systematic review and meta-analysis evaluates interventions associated with reduced loneliness and social isolation in older adults.

6. apa.org apa.org/monitor/2019/05/ce-corner-isolation

The risks of social isolation Hawkley points to evidence linking perceived social isolation with adverse health consequences including depression, poor sleep quality, impaired executive ...

7. mdpi.com mdpi.com/2227-9032/12/17/1736

Time Perspective and Perceived Social Isolation: The Role ... As such, CBT is a strongly supported option for reducing social interaction and anxiety and perceived social isolation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666915321000986

Cognitive behavioral analysis system of psychotherapy ... Loneliness and depressive symptoms significantly and independently decreased, whereas social network characteristics showed no change after 10 weeks of CBASP.