120 Participants Needed

Need to Be Needed Intervention for Social Isolation

(N2BN RCT Trial)

TN
BM
Overseen ByBryan Mccormick, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Temple University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how an intervention focused on volunteering and acts of kindness can reduce feelings of loneliness and social isolation in adults with serious mental illnesses, such as major depression, bipolar disorder, or schizophrenia. Participants will either join a group receiving weekly support to plan and engage in volunteering or a control group receiving general information and brief support sessions. The trial aims to determine if these activities can enhance participants' sense of being needed and connected. Individuals diagnosed with a mental illness like major depression or schizophrenia, who live in the community and feel lonely, might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to explore new ways to enhance social connections and improve mental well-being.

What prior data suggests that this intervention is safe for adults with serious mental illness?

Research has shown that activities aimed at reducing social isolation and loneliness are generally safe and well-received. For instance, studies on mindfulness and intergenerational programs have demonstrated their ability to reduce loneliness without major side effects. Although the "Need to Be Needed" program is new, it involves volunteering and support, which are typically safe activities.

The program includes weekly meetings with a support person to help set and achieve personal goals. This support is flexible and tailored to each individual, allowing adjustments to suit personal comfort levels and needs. This approach ensures the program is both effective and safe for participants.

Overall, activities like volunteering and support meetings are known to be safe. Participants can trust that the program prioritizes their well-being.12345

Why are researchers excited about this trial?

Researchers are excited about the "Need to Be Needed Intervention" because it offers a unique approach to tackling social isolation through supported volunteering. Unlike typical treatments that might focus on therapy or medication, this intervention involves direct, ongoing engagement with participants to develop personalized volunteering plans, which are flexible and adaptable over time. The interventionists provide regular support, promoting active participation and problem-solving, which could enhance participants' sense of purpose and connection with others. This method stands out because it emphasizes action and community involvement, rather than just passive information or traditional support methods.

What evidence suggests that the Need to Be Needed Intervention could be effective for reducing social isolation in adults with serious mental illness?

Research has shown that efforts to reduce loneliness can be quite effective. Psychological approaches, in particular, have moderate success in lessening loneliness. One study found that participants in mindfulness training felt 22% less lonely each day compared to those who did not participate. Group activities also appear to be a cost-effective way to reduce loneliness, even though study results vary. Overall, these findings suggest that organized support and activities, such as the Need to Be Needed Intervention being tested in this trial, could help reduce feelings of social isolation in adults with serious mental illness.16789

Are You a Good Fit for This Trial?

This trial is for adults with serious mental illnesses like Major Depression, Bipolar I/II, or Schizophrenia Spectrum disorder who feel socially isolated. They must live in the community, speak English, and score at least a 6 on the UCLA-Loneliness Scale.

Inclusion Criteria

I can speak and write in English.
I live at home, not in a hospital or care facility.
I have been diagnosed with Major Depression, Bipolar I, II, or Schizophrenia.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive weekly support from the interventionist to improve social connection through volunteering, kindness, and gratitude.

6 months
Weekly meetings (in-person or virtual)

Mid-point Assessment

Data collection at the mid-point of the intervention to assess changes in loneliness, social isolation, and other measures.

1 week
1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in social connection, loneliness, and other outcomes after the intervention.

4 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Need to Be Needed Intervention

Trial Overview

The study tests an intervention to reduce loneliness by engaging participants in acts of kindness and gratitude through volunteering. It compares this 'Need to Be Needed' approach with a control group receiving general support over six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Need to be Needed InterventionExperimental Treatment1 Intervention
Group II: Active control groupActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials
321
Recruited
89,100+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials
83
Recruited
10,500+

Citations

The effectiveness of interventions to prevent loneliness and ...

The results show interventions can potentially reduce loneliness in the non-institutionalized, community-dwelling and older population living at home.

Cost-Effectiveness of Interventions Addressing Loneliness ...

Group-based interventions appear generally cost-effective in reducing loneliness despite heterogeneities among studies.

Are Loneliness Interventions Effective for Reducing ...

Psychological interventions appeared to be the most effective intervention strategy for reducing loneliness, demonstrating a moderate effect, while social and ...

the effectiveness of interventions to address loneliness at ...

The authors conclusion is that trials data suggest that animal assistive therapy has little effect on loneliness outcomes. Music. One unpublished study ...

Interventions - Social Isolation and Loneliness in Older Adults

The study found that individuals who received mindfulness training reported a 22 percent reduction in daily loneliness compared with the control group; thus, ...

Needs of social isolation, loneliness, and intergenerational ...

This scoping review examines the effectiveness of intergenerational interventions aimed at reducing social isolation and loneliness among older adults in the ...

The risks of social isolation

"There is robust evidence that social isolation and loneliness significantly increase risk for premature mortality, and the magnitude of the risk exceeds that ...

Loneliness, Lack of Social and Emotional Support ...

Loneliness and isolation are indicators of social disconnection that can lead to poor mental and physical health outcomes, including increased ...

Social Isolation, Loneliness, and the Potential of Occupational ...

Most concerningly, socially isolated individuals have a 33% higher risk of death compared with socially connected peers (Naito et al., 2023), ...