Social Engagement Coaching for Loneliness

(R61 Phase Trial)

Overseen By Kim Van Orden, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Problem drinking, Psychosis, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 13

Duration: 16 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether an individual coaching program called Social Engage Coaching (or 'Engage Coaching' for short) helps adults age 60 and older feel more connected to other people in ways that matter to them. Procedures include participating in a Social Engage Coaching program, research assessments with surveys, and assessments completed on a cell phone. Engage Coaching involves individual sessions with a trained Engage Coach (up to 10 sessions) that are designed to help participants improve social relationships and well-being. All subjects will receive the scheduled baseline and follow-up interviews by the research team. These interviews will be conducted at study start, mid-way through the program at 8 weeks and after completing the program at 16 weeks. Interviews will be via Zoom/phone as well as surveys done online.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Social Engage Coaching (S-ENG) for loneliness?

Research shows that home-based interventions, like befriending and social navigation, can improve loneliness and social connectedness in older adults. Additionally, a modified Behavioral Activation approach has been effective in reducing loneliness and depressive symptoms, suggesting that similar strategies could be beneficial in the S-ENG treatment. ^{1 2 3 4 5}

Is Social Engagement Coaching safe for humans?

The research articles provided do not contain specific safety data for Social Engagement Coaching or its variants. However, interventions aimed at reducing loneliness, like social prescribing and befriending models, are generally considered safe as they focus on social interaction and connection rather than medical treatments. ^{1 6 7 8 9}

How is the Social Engage Coaching (S-ENG) treatment different from other treatments for loneliness?

Social Engage Coaching (S-ENG) is unique because it focuses on enhancing social skills and building meaningful connections, which are key elements identified as effective in reducing loneliness. Unlike other interventions that may not effectively address loneliness, S-ENG combines several active elements like 'interpersonal skills' and 'meaningful contact' to create a more targeted approach. ^{2 5 6 7 10}

Eligibility Criteria

This trial is for adults aged 60 or older living in senior communities who feel very lonely and have thought about suicide in the past month. They must be able to engage with coaching and assessments, which means no severe hearing issues, cognitive impairments, psychosis, or current heavy drinking.

Inclusion Criteria

I have felt very lonely and had thoughts of suicide in the last month.

I am 60 or older and live in a senior living community.

Exclusion Criteria

Current problem drinking

Psychosis

Significant cognitive impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a 1-week smartphone-based target assessment at baseline, including ecological momentary assessment (EMA) and passive sensing.

1 week

1 visit (virtual)

Treatment

Participants engage in Social Engage Coaching (S-ENG), which includes 10 individual coaching sessions over up to 4 months to improve social relationships and well-being.

16 weeks

10 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including follow-up assessments at 8 and 16 weeks with baseline and smartphone measures.

16 weeks

2 visits (virtual)

Treatment Details

Interventions

• Social Engage Coaching (S-ENG)

Trial Overview The study tests 'Social Engage Coaching' (S-ENG), a program aiming to improve social connections and well-being through up to 10 individual sessions with a coach. Participants will also complete surveys and interviews at the start, halfway point at 8 weeks, and after finishing at 16 weeks.

Participant Groups

Group I: Social Engage Coaching (S-ENG) Experimental Treatment 1 Intervention

Social Engage Coaching is 10 individual sessions of coaching to increase social connection.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The project successfully identified older adults experiencing social isolation and loneliness using validated assessment tools, demonstrating the effectiveness of these tools at the health plan level.

Interventions such as in-home caregiver visits and social navigation significantly improved loneliness and social isolation scores among participants, suggesting these approaches may be beneficial for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing social isolation and loneliness in older adults at the health plan level: A quality improvement project. Niemann, AL., Million, RM.[2023]

A modified version of Behavioral Activation, called Brief Behavioral Activation for Improving Social Connectedness, effectively reduced loneliness and depressive symptoms in homebound older adults, as shown in a recent randomized clinical trial.

The intervention, delivered over six weekly sessions by trained non-clinical individuals, shows promise for scalability in programs serving older adults, although further research is needed to confirm its long-term effectiveness and training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modifying Behavioral Activation to Reduce Social Isolation and Loneliness Among Older Adults. Pepin, R., Stevens, CJ., Choi, NG., et al.[2022]

Home-based interventions significantly improve social connectedness and reduce loneliness and depressive symptoms among older adults, based on a meta-analysis of 14 randomized controlled trials.

Interventions lasting more than three months and delivered through mixed platforms (like online and in-person) were particularly effective, suggesting that the format and duration of these programs are important for their success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of home-based interventions in improving loneliness and social connectedness among older adults: a systematic review and meta-analysis. Chua, CMS., Chua, JYX., Shorey, S.[2023]

The multicomponent intervention, modified CARELINK, did not show overall effectiveness in reducing social isolation or loneliness among older adults, but it did lead to improvements in confidential support and emotional loneliness scores in the experimental group.

Factors such as having supportive individuals and increased mobility were identified as important for reducing social isolation, suggesting that these elements should be considered in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a multicomponent intervention to reduce social isolation and loneliness in community-dwelling elders: A randomized clinical trial. Hernández-Ascanio, J., Perula-de Torres, LÁ., Rich-Ruiz, M., et al.[2023]

A literature review of 17 studies found that recent social therapeutic interventions, particularly those involving new technologies, significantly reduced loneliness in older adults.

Group work interventions also showed effectiveness in decreasing loneliness, highlighting the potential of both technological and social approaches in supporting older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing loneliness amongst older people: a systematic search and narrative review. Hagan, R., Manktelow, R., Taylor, BJ., et al.[2022]

The pilot testing of the cooperative card game 'Connections' showed that participants found it enjoyable and helpful in building social connections, with significant reductions in loneliness, depressed mood, and anxiety after playing.

Participants also reported increased enthusiasm for forming new connections and a greater willingness to open up to others, indicating the game's potential to enhance interpersonal relationships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection. Van Bogart, K., Johnson, JA., Nayman, S., et al.[2023]

A qualitative analysis of 119 loneliness interventions for older adults revealed seven key active elements that contribute to their effectiveness, including 'activities', 'meeting others', and 'meaningful contact'.

Most interventions that successfully reduce loneliness combine several of these active elements, suggesting that a strategic mix and good execution can enhance their overall effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Towards a more focused approach to loneliness: Seven active elements in loneliness interventions]. Bouwman, TE., van Tilburg, TG.[2020]

An umbrella review of 211 studies identified three effective interventions for reducing loneliness: meditation/mindfulness, social cognitive training, and social support, with varying degrees of statistical significance.

Despite these findings, the evidence supporting these interventions is rated as low to very low, highlighting the need for more large-scale randomized controlled trials to confirm their efficacy in reducing loneliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for reducing loneliness: An umbrella review of intervention studies. Veronese, N., Galvano, D., D'Antiga, F., et al.[2022]

Social loneliness is a significant health issue linked to various adverse outcomes, and the UK has implemented social prescribing as a nonpharmacological intervention to address it, showing a growing global trend in this approach.

From 2018 to 2022, there was a nearly 15-fold increase in discussions around social prescribing, with key themes emerging in mental health, community initiatives, and the importance of governance in implementing these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global Trends in Social Prescribing: Web-Based Crawling Approach. Lee, H., Koh, SB., Jo, HS., et al.[2023]

A pilot intervention in Spain aimed at reducing loneliness among older adults showed significant decreases in loneliness and increases in social participation and support after the program, with 38 participants involved over a 2-year follow-up.

The intervention not only maintained social connections and reduced depressive symptoms two years later, but also demonstrated the feasibility of using a social capital-based approach to improve the well-being of lonely older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting social capital to alleviate loneliness and improve health among older people in Spain. Coll-Planas, L., Del Valle Gómez, G., Bonilla, P., et al.[2022]

References

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

Addressing social isolation and loneliness in older adults at the health plan level: A quality improvement project. [2023]

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

Modifying Behavioral Activation to Reduce Social Isolation and Loneliness Among Older Adults. [2022]

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

Effectiveness of home-based interventions in improving loneliness and social connectedness among older adults: a systematic review and meta-analysis. [2023]

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

Effectiveness of a multicomponent intervention to reduce social isolation and loneliness in community-dwelling elders: A randomized clinical trial. [2023]

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

Reducing loneliness amongst older people: a systematic search and narrative review. [2022]

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

Iterative Design, Feasibility, and Preliminary Efficacy Testing for the Development of a Cooperative Card Game Intervention to Reduce Loneliness and Foster Social Connection. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

[Towards a more focused approach to loneliness: Seven active elements in loneliness interventions]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Interventions for reducing loneliness: An umbrella review of intervention studies. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Global Trends in Social Prescribing: Web-Based Crawling Approach. [2023]

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

Promoting social capital to alleviate loneliness and improve health among older people in Spain. [2022]