Social Prescribing and Cognitive Therapy for Social Isolation

Enrolling by invitation at 1 trial location

Overseen By Paul Pfeiffer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Specialty mental health, Neurocognitive impairment, others

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

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two approaches to reduce loneliness: Social Prescribing and Brief Cognitive Therapy. Social Prescribing links individuals to community activities and resources, while Brief Cognitive Therapy provides short counseling sessions to alter negative thoughts. Researchers aim to determine if participants find these treatments practical and welcoming. The trial suits individuals who have recently felt isolated or have experienced thoughts of self-harm in the past year, and who can join or are already part of Collaborative Care Management. As an unphased trial, it presents a unique opportunity to explore innovative treatments for loneliness and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on social and cognitive therapies, so it's likely you can continue your medications, but you should confirm with the study team.

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

Research shows that both Social Prescribing and Brief Cognitive Therapy are generally safe. Studies on Brief Cognitive Therapy have found it reduces feelings of loneliness and depression without major side effects. Research indicates that Social Prescribing can enhance mental and physical health by connecting individuals with social activities or community resources. These treatments aim to strengthen social connections, which are important for overall well-being. Both approaches are well-tolerated, making them promising options for addressing loneliness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative methods to tackle social isolation through two distinct approaches: Brief Cognitive Therapy (BCT) and Social Prescribing. Unlike traditional treatments that may focus solely on medication or therapy sessions, BCT aims to quickly equip individuals with practical skills to manage loneliness, potentially offering faster relief. Meanwhile, Social Prescribing connects participants to community resources and activities, promoting engagement and reducing isolation in a holistic way. By examining these approaches in combination and sequence, the trial seeks to uncover how these methods can complement each other to offer more comprehensive support for those feeling isolated.

What evidence suggests that this trial's treatments could be effective for improving loneliness?

Research has shown that Brief Cognitive Therapy can help reduce loneliness. This therapy uses techniques to change negative thinking patterns, significantly decreasing feelings of loneliness for many people. Some participants in this trial will receive Brief Cognitive Therapy followed by Social Prescribing, while others will receive Social Prescribing followed by Brief Cognitive Therapy.

Social Prescribing has also shown promise in reducing loneliness. It connects people to community resources and activities, helping them feel less isolated. In some cases, up to 69% of participants reported feeling less lonely after joining social prescribing programs. Both treatments in this trial aim to strengthen social connections and improve mental well-being. ^{3 6 7 8 9}

Who Is on the Research Team?

Paul Pfeiffer, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals experiencing suicidal thoughts or feelings of extreme loneliness. Participants should be interested in trying new treatments aimed at improving their social connections and mental health.

Inclusion Criteria

Loneliness according to the 3-item version of the University of California, Los Angeles (UCLA) Loneliness Scale

Currently receiving or able to initiate Collaborative Care Management at participant's study site

I have felt socially isolated or had thoughts of suicide in the last year.

Exclusion Criteria

Neurocognitively impaired

Currently receiving or have an active referral for specialty mental health or substance use disorder treatment outside of primary care

Unable to participate in the interventions and research assessments due to planned travel or limited phone access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey to assess initial conditions

1 week

1 visit (online or phone)

Treatment

Participants receive either Social Prescribing followed by Brief Cognitive Therapy or vice versa

12 weeks

4 sessions (online or phone)

Follow-up

Participants are monitored for safety and effectiveness after treatment with surveys at 3 and 6 months

24 weeks

2 visits (online or phone)

What Are the Treatments Tested in This Trial?

Interventions

• Brief Cognitive Therapy
• Social Prescribing

Trial Overview The study is examining the effectiveness of Social Prescribing, which connects people to community resources, and Brief Cognitive Therapy, a short-term therapy focusing on changing negative thought patterns.

How Is the Trial Designed?

Group I: Social Prescribing then Brief Cognitive Therapy Experimental Treatment 2 Interventions

Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.

Group II: Enhanced Usual Care control group Experimental Treatment 1 Intervention

Participants will receive an informational booklet on improving loneliness and may initiate or continue Collaborative Care for other conditions on a not research basis. Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.

Group III: Brief Cognitive Therapy then Social Prescribing Experimental Treatment 2 Interventions

Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Imagery-enhanced cognitive behavioural group therapy (IE-CBGT) for social anxiety disorder (SAD) was well-received by patients, showing high attendance and completion rates among the 19 participants in the study.

IE-CBGT demonstrated large to very large effect sizes in reducing performance and social interaction anxiety, suggesting it may be more effective than traditional CBGT, although further research with larger randomized controlled trials is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. McEvoy, PM., Saulsman, LM.[2019]

Citations

1. 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3865701/

A Meta-Analysis of Interventions to Reduce Loneliness - PMC Some studies even showed that combining CBT with social skills training was more effective in treating lonely and socially anxious adults than either treatment ...

3. 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.

4. 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.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-023-17097-2

What works in interventions targeting loneliness: a systematic ... The study utilising cognitive behavioural therapy (CBT) principles [33] showed a significant reduction in loneliness for the entire sample, both ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357115/

The Impact of Loneliness and Social Isolation on Cognitive ... This narrative review will present the key literature exploring the role of loneliness and social isolation in poor cognitive decline and dementia risk. The ...

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

The risks of social isolation Social isolation and chronic loneliness place individuals at much greater risk for a variety of diseases, as well as for premature mortality. Loneliness is ...

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.

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

Can we mitigate the psychological impacts of social ... The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=−0.31, 95% CI −0.51 to −0.11) ...