Social Prescribing and Cognitive Therapy for Social Isolation

Recruiting 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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy. For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.

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.

What data supports the effectiveness of the treatment Brief Cognitive Therapy, Social Prescribing for social isolation?

Research on cognitive behavioral group therapy (CBGT) for social anxiety disorder shows that it is effective, especially when enhanced with imagery techniques, which may also help with social isolation. Additionally, cognitive therapy for social anxiety disorder has been shown to be effective, suggesting that similar approaches could benefit those experiencing social isolation. ^{1 2 3 4 5}

Is cognitive therapy safe for treating social anxiety and related conditions?

Cognitive therapy, including brief and internet-based versions, has been studied for social anxiety and is generally considered safe for humans. These therapies have shown positive outcomes with no significant safety concerns reported in the studies. ^{1 3 6 7 8}

How is the treatment of social isolation with social prescribing and brief cognitive therapy different from other treatments?

This treatment is unique because it combines social prescribing, which connects people to community services and activities to improve social connections, with brief cognitive therapy, a psychological approach that helps change negative thought patterns. Unlike traditional treatments that may focus solely on medication or long-term therapy, this approach aims to address social isolation by enhancing social engagement and providing short-term mental health support. ^{3 8 9 10 11}

Research Team

Paul Pfeiffer, MD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing the efficacy of imagery-enhanced cognitive behavioral group therapy for social anxiety disorder: Study protocol for a randomized controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Imagery-enhanced cognitive behavioural group therapy for social anxiety disorder: a pilot study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

More than doubling the clinical benefit of each hour of therapist time: a randomised controlled trial of internet cognitive therapy for social anxiety disorder. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of interpersonal therapy versus supportive therapy for social anxiety disorder. [2008]

5. England pubmed.ncbi.nlm.nih.gov

Exposure in vivo vs social skills training for social phobia: long-term outcome and differential effects. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Brief cognitive therapy for social phobia: a case series. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effectiveness and cost-effectiveness of a fully self-guided internet-based intervention for sub-clinical social anxiety symptoms: Protocol for a randomised controlled trial. [2022]

9. Poland pubmed.ncbi.nlm.nih.gov

INTERNET-DELIVERED LOW-INTENSITY CBT FOR PEOPLE WITH SOCIAL ANXIETY DISORDER IN A PERIOD OF COVID-19: RESULTS OF PILOT RESEARCH. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Treating social anxiety disorder remotely with cognitive therapy. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Social skills training: an effective treatment for unipolar non-psychotic depression? [2019]