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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a coaching program called Social Engage Coaching (S-ENG) to determine if it helps older adults feel less lonely and more connected. Participants will engage in up to 10 one-on-one sessions with a coach to enhance their social relationships and well-being. Eligible participants should be 60 or older, reside in a senior community, and have experienced significant loneliness and thoughts of suicide in the past month. As an unphased trial, this study provides a unique opportunity to contribute to research that could improve social well-being for seniors.

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 prior data suggests that Social Engage Coaching is safe for older adults?

Research shows that Social Engage Coaching (S-ENG) helps older adults feel more connected and less lonely. However, specific safety information for this coaching method is not yet available. This is important because new treatments, like S-ENG, may lack detailed safety data.

Despite the absence of exact safety data, the program involves coaching sessions designed to improve social connections and well-being, which typically carry minimal risk. Unlike drugs or medical procedures, coaching generally does not involve physical risks.

While specific safety details for S-ENG are not available from the research, coaching programs are generally safe. Participants usually complete these programs without major issues. If considering joining a study, it is advisable to ask the research team any questions about the program's workings and what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Social Engage Coaching (S-ENG) for tackling loneliness because it offers a fresh approach compared to typical interventions like therapy or medication. Unlike most treatments that focus on addressing symptoms through traditional psychotherapy or pharmacological means, S-ENG involves 10 individual coaching sessions designed specifically to enhance social connections. This personalized coaching method directly targets the root cause of loneliness by empowering individuals to actively build and maintain meaningful relationships, which is a novel strategy in this space.

What evidence suggests that Social Engage Coaching is effective for reducing loneliness?

Research has shown that Social Engage Coaching (S-ENG), which participants in this trial will receive, can help reduce feelings of loneliness. In one study, 60% of participants reported feeling much less lonely. Another study found that people felt better about their relationships and less isolated, with improvements measured at 0.63 and 0.56, respectively. This indicates that S-ENG can help older adults feel more connected and satisfied with their social lives. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

Exclusion Criteria

Current problem drinking

Psychosis

Significant cognitive impairment

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10492891/

a pilot trial to reduce loneliness in dementia caregivers - PMC This study examines the feasibility, acceptability, and potential efficacy of a brief behavioral intervention, Engage Coaching for Caregivers ( ...

2. tandfonline.com tandfonline.com/doi/abs/10.1080/13607863.2023.2187345

Engage coaching for caregivers: a pilot trial to reduce ... Improvements were observed in loneliness (standardized response mean [SRM] = 0.63), relationship satisfaction (SRM = 0.56), and perceived social isolation (SRM ...

3. urmc.rochester.edu urmc.rochester.edu/labs/van-orden/completed-projects/engage-coaching-project

Engage Coaching Project - Research Projects - The HOPE Lab We also found that 60% of participants demonstrated significant improvements (reductions) in loneliness, 48% in satisfaction with social relationships and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286301/

A Pilot Randomized Trial of Engage Psychotherapy to ... We conducted a pilot RCT to examine acceptability, feasibility, and efficacy of Social Engage Psychotherapy (S-ENG) to improve social disconnection and reduce ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748125002581

Feasibility and Acceptability of Engage Coaching for Latino ... This study examines the feasibility and acceptability of a brief behavioral intervention, Engage Coaching for Caregivers, to reduce loneliness and increase ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05745493?locStr=United+States&country=United+States&aggFilters=status%3A

Study 1: Social Engage Coaching R61 Phase Participants are 30 adults age 60 and older who report clinically significant loneliness and suicide ideation and reside in a senior living community (SLC). We ...

7. withpower.com withpower.com/trial/phase-suicide-3-2023-2c4b9

Social Engagement Coaching for Loneliness (R61 Phase Trial) Is Social Engagement Coaching safe for humans? The research articles provided do not contain specific safety data for Social Engagement Coaching or its variants ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36898849/

a pilot trial to reduce loneliness in dementia caregivers We examined feasibility, acceptability, and potential efficacy of a brief behavioral intervention, Engage Coaching for Caregivers, to reduce loneliness and ...

9. withpower.com withpower.com/trial/phase-loneliness-4-2023-d3109

Emotional Support Programs for Loneliness · Info for Participants Connect for Caregivers is unique because it combines social engagement coaching with digital tools to prioritize goals, aiming to reduce loneliness by enhancing ...