Emotional Support Programs for Loneliness

Overseen By Jeff Swan, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Non-English, Cognitive impairment, Cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines programs designed to assist caregivers experiencing loneliness or stress. It evaluates the effectiveness of various coaching methods, such as "Connect for Caregivers" and "Social Engage Coaching," both with and without a digital tool, in helping caregivers connect socially and manage their emotions. The trial seeks caregivers aged 50 or older who care for a loved one with Alzheimer's or similar memory issues and currently experience high stress or loneliness. As an unphased trial, it provides caregivers a unique opportunity to explore innovative support methods and enhance their well-being.

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 these emotional support programs are safe?

Research has shown that Social Engage Coaching is generally safe and manageable. Past studies have demonstrated that this approach helps older caregivers strengthen social connections. These studies reported no major negative effects, indicating safety for participants. Social Engage Coaching involves simple activities like setting goals to enhance social interactions, suggesting a low risk of harm.

The version called Social Engage Coaching with Connect for Caregivers also appears safe. It incorporates a digital tool to help set priorities, building on the already safe method. This small addition likely maintains its well-tolerated nature.

In summary, both treatments aim to improve social connections without medications or invasive procedures, making them low-risk options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for loneliness because they focus on enhancing social connections, which isn't always the primary target of standard treatments like medication or traditional therapy. Social Engage Coaching emphasizes psychoeducation and structured goal setting to build social ties, offering a proactive approach rather than just addressing symptoms. Additionally, the integration of a digitized prioritization tool in Social Engage Coaching with Connect for Caregivers provides a personalized and modern twist, helping participants prioritize and achieve their social goals more effectively. These innovative methods aim to tackle loneliness by directly improving the social engagement of individuals, which could lead to more sustainable mental health benefits.

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

Research has shown that Social Engage Coaching, one of the programs tested in this trial, can help reduce loneliness among caregivers. In one study, 60% of participants felt significantly less lonely, and nearly half reported greater satisfaction with their social relationships. Most participants, 83%, found the program convenient and said it met their expectations. The program uses structured goal setting and problem-solving to foster social connections.

Another program in this trial, Social Engage Coaching with Connect for Caregivers, demonstrated similar benefits. This version includes a digital tool to help prioritize social goals, guiding interventions and improving results. Like the basic program, this enhanced version also reduced loneliness and improved social connections for caregivers. ^{1 5 6 7 8}

Who Is on the Research Team?

Kathi Heffner, PhD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for caregivers aged 50 or older who look after a loved one with Alzheimer's or related diseases at home. They must feel stressed above average levels, have moderate caregiver strain, and experience loneliness. Those with major heart conditions, non-English speakers, or significant cognitive issues cannot join.

Inclusion Criteria

Elevated caregiving distress: above population mean (>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score >= 5) on the Modified Caregiver Strain Index

Social disconnection: UCLA Loneliness Scale: Short Form score of > 5

I am over 50 and care for someone with Alzheimer's or similar, living close by.

Exclusion Criteria

I have significant difficulty with my memory or thinking.

I do not have major heart conditions like heart failure or a pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Social Engage Coaching, which includes psychoeducation on social connections and structured goal setting for increasing social connectedness. Some participants also use a digitized prioritization tool.

11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of loneliness and cognitive tasks.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Connect for Caregivers
• Social Engage Coaching
• Social Engage Coaching with Digitization Prioritization of Goals

Trial Overview The study tests two interventions: 'Connect for Caregivers', a behavioral coaching program aimed at reducing loneliness; and 'Social Engage Coaching', which uses digital tools to help coaches improve their support to caregivers.

How Is the Trial Designed?

Group I: Social Engage Coaching Active Control 1 Intervention

Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving for increasing social connectedness.

Group II: Social Engage Coaching with Connect for Caregivers Active Control 2 Interventions

Social Engage Coaching involves psychoeducation on the importance of social connections for health as well as structured goal setting and problem solving, guided by use of a digitized prioritization tool, for increasing social connectedness.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The Engage Coaching intervention was feasible and well-accepted by older caregivers of people with dementia, with 83% of participants feeling it met their expectations and 100% finding it suitable and convenient.

Participants showed significant improvements in loneliness, relationship satisfaction, and perceived social isolation, indicating that Engage Coaching may effectively enhance social connections for these caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engage coaching for caregivers: a pilot trial to reduce loneliness in dementia caregivers. Van Orden, KA., Bower, E., Lutz, J., et al.[2023]

The web-based peer support intervention for informal caregivers of military service members was used infrequently, with over 60% of participants visiting the site once a month or less, but most users reported moderate to high satisfaction, primarily using it for informational support.

Participants expressed a strong need for emotional support and preferred more active engagement with other caregivers, suggesting that while the online platform is helpful, it should be complemented with in-person support groups to better address emotional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informal Caregivers' Experiences and Perceptions of a Web-Based Peer Support Network: Mixed-Methods Study. Vaughan, C., Trail, TE., Mahmud, A., et al.[2023]

Military caregivers who joined a new online peer support group experienced a reduction in perceived social isolation after 3 months, but this effect did not last at 6 months, indicating that initial benefits may fade over time.

Increased engagement with online support groups was linked to lower perceived social isolation, suggesting that active participation is key, but the study found no significant improvement in depressive symptoms, highlighting the need for additional treatment options for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Engagement in Online Support Groups and Social Isolation Among Military Caregivers: Longitudinal Questionnaire Study. Trail, T., Friedman, E., Rutter, CM., et al.[2020]

A randomized controlled trial involving 122 caregivers of people with dementia will evaluate the effectiveness of the 'Inlife' social support tool over 16 weeks, focusing on primary outcomes like caregiver competence and perceived social support.

The study will also assess secondary outcomes such as feelings of loneliness, psychological complaints, and quality of life, providing comprehensive insights into the usability and impact of the Inlife intervention on caregiver well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an online social support intervention for caregivers of people with dementia: the study protocol of a randomised controlled trial. Dam, AEH., de Vugt, ME., van Boxtel, MPJ., et al.[2022]

An integrative review of 12 studies found that interventions for caregivers of individuals with dementia primarily included peer support, mindful meditation, and music therapy, but most showed only small effects on reducing loneliness.

There is a significant need for better-designed interventions that effectively address loneliness in informal caregivers, particularly those that enhance social networks and emotional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions to reduce loneliness in caregivers: An integrative review of the literature. Velloze, IG., Jester, DJ., Jeste, DV., et al.[2022]

Interventions aimed at improving social connections for caregivers of individuals with Alzheimer's disease should incorporate caregiver perspectives and adapt to the varying stages of dementia to be effective.

The development of mechanism-informed interventions is underway, focusing on reducing loneliness and maximizing resources while addressing the unique demands faced by caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Social Connection in Dementia Caregivers: A Call for Empirical Development of Targeted Interventions. Van Orden, KA., Heffner, KL.[2023]

Psychoeducational videoconferencing interventions are effective in enhancing caregiving skills and wellness among informal caregivers, as shown in a systematic review of 14 randomized controlled trials published between 2012 and 2022.

Caregivers reported high satisfaction with these interventions, appreciating their usability and structure, although some faced technical issues; improving connectivity and incorporating respite care could further enhance the feasibility and effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, usability, and acceptability of psychoeducational videoconferencing interventions for informal caregivers: A systematic review of randomized controlled trials. Sang, E., Hirschman, KB., Bowles, KH.[2023]

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]

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 ... 83% indicated the program met expectations and 100% reported the program was suitable and convenient. Improvements were observed in loneliness (standardized ...

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

a pilot trial to reduce loneliness in dementia caregivers Results: Engage Coaching was feasible to deliver, with n = 25 of 30 enrolled completing at least 80% of sessions. 83% indicated the program met expectations and ...

4. 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 ...

5. researchgate.net researchgate.net/publication/350587508_A_Pilot_Randomized_Trial_of_Engage_Psychotherapy_to_Increase_Social_Connection_and_Reduce_Suicide_Risk_in_Later_Life

A Pilot Randomized Trial of Engage Psychotherapy to ... Social Engage did not show preliminary evidence of impact on belonging or perceived burden but was effective in reducing depressive symptoms and ...

6. 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 ...

7. artsfortheaging.org artsfortheaging.org/wp-content/uploads/2023/05/USAging_engAGED_Best-Practices-Brochure.pdf

Social Engagement Innovations and Best Practices Social Engage. Coaching was adapted from Engage Psychotherapy, an evidence-based treatment for depression in later life, to focus on social engagement and ...

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

Study 1: Social Engage Coaching R61 Phase Social Engage Coaching is 10 individual sessions of coaching to increase social connection. Intervention/Treatment, Behavioral : Social Engage Coaching (S-ENG).