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

57 Participants Needed

Trial Summary

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 Connect for Caregivers, Social Engage Coaching, Engage Coaching for Caregivers, Social Engage, Engage Psychotherapy to Promote Connectedness in Caregivers, Social Engage Coaching with Digitization Prioritization of Goals, Social Engage Psychotherapy for loneliness?

Research suggests that interventions like Engage Coaching for Caregivers and social support tools can help reduce loneliness and improve social connections for caregivers, especially those caring for people with dementia. These interventions often focus on expanding social networks and providing emotional support, which have shown promising effects in reducing loneliness. ^{1 2 3 4 5}

Is the Emotional Support Program for Loneliness safe for humans?

The research does not provide specific safety data for the Emotional Support Program for Loneliness, but similar interventions like videoconferencing and peer support have been found to be generally acceptable and usable by caregivers, with no major safety concerns reported. ^{1 2 5 6 7}

How is the treatment 'Connect for Caregivers' different from other treatments for loneliness in caregivers?

Connect for Caregivers is unique because it combines social engagement coaching with digital tools to prioritize goals, aiming to reduce loneliness by enhancing social connections and emotional support for caregivers, especially those caring for people with dementia. Unlike other interventions, it focuses on personalized coaching and the use of technology to tailor support to individual needs. ^{1 2 5 6 8}

What is the purpose of this trial?

A specific aim of this research is to identify the role of emotion regulation in response to social threat in caregivers' response to a behavioral coaching intervention for loneliness. A second aim of the study is to determine the benefit of a digitized, social engagement prioritization tool for improving coaches' intervention fidelity and caregiver outcomes. This study is funded through the Pilot Award Program of the Rochester Roybal Center for Social Ties \& Aging Research, a UR Center funded by the National Institute on Aging by grant P30AG064103.

Research Team

Kathi Heffner, PhD

Principal Investigator

University of Rochester

Eligibility Criteria

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

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.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Interventions to reduce loneliness in caregivers: An integrative review of the literature. [2022]

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

Promoting Social Connection in Dementia Caregivers: A Call for Empirical Development of Targeted Interventions. [2023]

3. England 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. [2022]

4. 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]

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

Engage coaching for caregivers: a pilot trial to reduce loneliness in dementia caregivers. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Informal Caregivers' Experiences and Perceptions of a Web-Based Peer Support Network: Mixed-Methods Study. [2023]

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

Feasibility, usability, and acceptability of psychoeducational videoconferencing interventions for informal caregivers: A systematic review of randomized controlled trials. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

The Relationship Between Engagement in Online Support Groups and Social Isolation Among Military Caregivers: Longitudinal Questionnaire Study. [2020]