An interventional study of Combatting Social Isolation and Health Education Training in Loneliness and Social Isolation, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Florida State University · Not applicable, Interventional, and Treatment
Increasing evidence suggests that perceived social isolation and loneliness are major risk factors for physical and mental illness in later life. The prevalence of loneliness in US older adults warrants concern, with an estimated 30% of American adults aged 70 years and older reporting heightened loneliness. A wide variety of interventions have been developed to address social isolation and loneliness ranging from social facilitation to animal therapies. While many intervention studies have attempted to address loneliness, social isolation and related constructs in older adults, this literature is underdeveloped and there is not an established or widely accepted set of treatments. Moreover, existing treatments tend to be lengthy, burdensome, and result in high dropout rates.
Brief, mechanism focused interventions are an alternative to more traditional forms of treatment. Because they are structured and brief, these treatments can be readily placed on the internet, making them extremely efficient, destigmatizing, and highly scalable. The investigators have developed and tested a web-based intervention called "Combating Social Isolation" (CSI) that the investigators believe offers an alternative to existing interventions for loneliness and social isolation in older adults. CSI evolved out of Interpersonal Theories of mood psychopathology (Joiner, 2005) and targets two risk factors central to social disconnection: perceived burdensomeness and thwarted belongingness (PB/TB). The investigators have one randomized clinical trial using CSI and are nearing completion of two other RCTs using this intervention. Evidence shows that CSI has very high levels of acceptability, and despite the brevity of the protocol (approximately 1 hour) can markedly impact loneliness. Moreover, reductions in these risk factors mediate later improvements in mental health outcomes and social disruption. The purpose of the current proposal is to adapt our existing protocol for older adults reporting loneliness and then obtain preliminary acceptability and efficacy data from a Phase II randomized clinical trial.
The study design involves protocol refinement and clinical trial evaluation phases:
Design Considerations. As with any project, there are a broad array of design options that may yield relevant information. In this section, the investigators summarize some of the key issues that contributed to the proposed study design.
Protocol Modification. Given that the existing protocol shows efficacy, there is some risk in modifying it. Therefore, our approach will be similar to other refinement studies where the investigators keep the core skills covered but substitute specific content areas with more relevant information. As noted above, the unique features of aging relevant to loneliness need to be incorporated (e.g., death of spouse, close friends, loss of independence). For example, one version of CSI includes vignettes and descriptions of active duty soldiers and Veterans that are unlikely to be relevant to many older adults. This content would be removed and replaced with vignettes featuring older adults with content that is appropriate and more typical for older adults.
Using a Semi-active Control Condition in the RCT. There are many different RCT designs that could be utilized including a waitlist control, which is likely to yield a larger effect size difference with the active intervention. However, prior studies suggest that CSI can outperform the proposed control condition, and this control condition helps to account for many confounds that a waitlist does not. Therefore, the investigators believe our choice of a stronger control group is warranted. Our "Healthy Lifestyle" control condition is also a web-based protocol that covers information and skills that many people believe to be helpful. Moreover, most participants find this control condition to be useful.
Limited Follow-up. Having a follow-up is important to demonstrate the initiation as well as some durability of treatment effects since the investigators would not expect immediate (post treatment) change in the outcomes of interest. As with any skill building protocol, time is needed for skills to be implemented. On the other hand, the duration of the grant period (12 months) limits the length of a viable follow-up period. The investigators believe that a one-month follow-up will be sufficient to show whether there are any treatment effects. Additional studies will be needed to demonstrate longer term benefits of the intervention.
75 studies on the registry are indexed under Social Isolation; 39 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 66 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →Florida State University is the lead sponsor of 245 studies on the registry; 46 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Exclusion Criteria:
Health Education Training (HET) control condition covers standard healthy lifestyle behaviors as well as broad coping strategies to address stress. HET is a fully computerized 1-hour control condition focused on increasing healthy behaviors and decreasing unhealthy behaviors. Content includes healthy eating, hydration, sleep and rest, exercise, stress management as well as other healthy lifestyle tips. The HET protocol has been used in prior studies as a control condition for CSI to account for intervention modality and time (e.g. Schmidt et al., 2014). HET is perceived positively, with high rates of acceptability. Importantly, HET is inert with respect to the proposed mechanism of action (PB/TB) (Schmidt et al., 2014; Schmidt et al., 2007; Short et al., 2015). Also, home practice will be prescribed to match the procedures used in CSI and practice forms are provided wherein participants will self-monitor some of the behaviors addressed in HET.
Behavioral: Health Education Training
Combating Social Isolation (CSI). CSI and a similar version of this intervention called "Building Stronger Allies", has gone through a rigorous treatment development phase, pilot RCT, and larger RCTs (Schmidt et al., 2014; Schmidt et al., 2017; Schmidt et al., 2007; Norr et al., 2017; Short et al., 2015; Short et al., 2017a; Schmidt et al., submitted for publication). CSI is a transdiagnostic cognitive behavioral therapy (CBT)-based protocol designed to address elevated perceived burdensomeness (PB) and thwarted belongingness (TB). The CSI intervention was designed in consultation with clinicians experienced in treating individuals dealing with issues related to PB/TB. CSI is a fully computerized, 1-hour intervention. The latest version of CSI uses Vyond software for video animation and audio narration throughout, as well as interactive features (e.g., brief quizzes to promote comprehension). Procedures draw heavily on standard CBT techniques.
Behavioral: Combatting Social Isolation
A brief, computerized psychoeducational intervention designed to target ways to cope with and address loneliness and social isolation in older adults modeled after our group's previous Building Stronger Allies (BSA) intervention.
Control condition where participants learn about healthy lifestyle behaviors.
Also known as: Control
University of California Los Angeles Loneliness Scale
Scores range from 20-80 with higher scores indicating higher levels of loneliness.
Time frame: 1-month
Interpersonal Needs Questionnaire
Measures Perceived Burdensomeness \& Thwarted belongingness - Scores from Thwarted Belongingness range from 9-63 with higher scores indicating more thwarted belongingness. Perceived burdensomeness scores range from 6-42 with higher scores indicating more perceived burdensomeness
Time frame: 1-month
Berkman Social Network Inventory
Measures Structural Social Isolation with scores ranging from 0-infinity (scores are total number of people in their social network) and density of social network calculated depending on size of social network.
Time frame: 1-month
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Scores range from 8-40 with higher scores indicating more anxiety symptoms.
Time frame: 1-month
Patient Reported Outcomes Measurement Information System - Emotional Distress-Depression-Short Form
Scores range from 8-40 with higher scores indicating more depressive symptoms.
Time frame: 1-month
World Health Organization Quality of Life Scale (WHOQOL-Brief)
Scores range from 26-105 with higher scores indicating higher perceived quality of life.
Time frame: 1-month
Patient Reported Outcomes Measurement Information system - Perceived Stress
Scores range from 10-50 with higher scores indicating higher levels of perceived stress
Time frame: 1-month
Schmidt Lab Acceptability Questionnaire
Semi-structured interviews will gauge participant attitudes toward the acceptability of and their satisfaction with with the CSI intervention. Scored items will range from 0-4 with higher scores indicating higher satisfaction with the intervention (e.g. how would you rate the quality of the intervention 0 being very low quality and 4 being very high quality).
Time frame: 1-month
Plan to share: No — No plan to make IPD available to other researchers
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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