Combatting Social Isolation in Older Adults

Loneliness Clinical Trial

— CSI  

Official title:

Combating Social Isolation in Older Adults: Randomized Clinical Trial Evaluating the Acceptability and Efficacy of a Brief, Technology Delivered Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426837
• Other study ID #: STUDY00003135
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2022
• Est. completion date: July 2024

Study information

• Verified date: March 2024
• Source: Florida State University
• Contact: Norman B Schmidt, Ph.D.
• Phone: 8506451766
• Email: schmidt[@]psy.fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The study design involves protocol refinement and clinical trial evaluation phases:

1. Refinement. The first phase of this proposal involves refining our existing protocol - "Combating Social Isolation" based on feedback from the target population (i.e., older adults experiencing loneliness). A small but representative sample of older adults (> age 64) (diversified by race, gender, and SES) from the Tallahassee metropolitan area will review the intervention and provide feedback (N approximately 12). The existing protocol includes psychoeducation about healthy relationships, "myth busting" around cognitive errors associated with loneliness (largely focused on social interaction) as well as skill building for social relationships. During the refinement phase, input from our collaborator with expertise in the development and use of technologies in older adults (Dr. Boot) will be utilized in an attempt to ensure good acceptability across the sample. Input from our collaborators specializing in interventions for older adults (Drs. Sheffler and Van Orden) will also be incorporated prior to and following feedback from participants. Feedback regarding ease of use, comprehension, limitations, and suggestions will be solicited using semi-structured interviews. Based on these assessments, the treatment will be redesigned accordingly. This phase is expected to take approximately 2 months. Note that the investigators have completed similar refinements for this intervention as well as others for particular populations (e.g., active duty military, first responders, Latinx) including the translation to different cultures and countries (e.g., Mexico, Japan, Germany, Australia).

2. Randomized Clinical Trial (RCT). Following refinement, the investigators will initiate a RCT focused on indicated prevention of adverse sequelae resulting from elevated loneliness. The final phase of the proposal will be used to determine the relative efficacy of the refined intervention versus a health education control condition. The rationale for an indicated prevention RCT is that only a subset of older adults' experiences significant loneliness. The investigators believe that this is an optimal target for an initial clinical trial for this intervention. An alternative approach would be to conduct a universal prevention RCT using a nonselected group of older adults. While the investigators believe that many (perhaps most) individuals would benefit from the information and skills covered in CSI, a more focused clinical trial at this stage would offer a more efficient means of demonstrating efficacy in the subgroup of older adults most likely to benefit from this intervention. Outcomes will be compared at post-treatment and at a one-month follow-up. The main dependent variables of interest will include loneliness, quality of interpersonal relationships and internalizing symptoms (anxiety and depression). This phase is expected to last 10 months.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Access to text message reminders

• Elevated loneliness (i.e. higher than a score of 5 on the Hughes et al., 2004, Short Scale for Measuring Loneliness in Large Surveys)

• Treatment stability will be required in terms of both psychopharmacology (2 month stable dose) as well as psychotherapy (2 months of ongoing treatment).

Exclusion Criteria:

• Evidence of significant medical conditions including visual, auditory or cognitive impairments that would prevent comprehension of the intervention materials.

• Participants who change medications or initiate psychotherapy during the follow-up interval will be evaluated separately and potentially excluded from the main analyses.

Related Conditions & MeSH terms

• Loneliness
• Social Isolation

Intervention

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.
• Health Education Training
Control condition where participants learn about healthy lifestyle behaviors.

Locations

Country	Name	City	State
United States	Anxiety and Behavioral Health Clinic	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	Retirement Research Foundation

Country where clinical trial is conducted

United States, 

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* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	1-month
Primary	University of California Los Angeles Loneliness Scale	Scores range from 20-80 with higher scores indicating higher levels of loneliness.	1-month
Primary	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	1-month
Secondary	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.	1-month
Secondary	Patient Reported Outcomes Measurement Information System - Anxiety Short Form	Scores range from 8-40 with higher scores indicating more anxiety symptoms.	1-month
Secondary	Patient Reported Outcomes Measurement Information System - Emotional Distress-Depression-Short Form	Scores range from 8-40 with higher scores indicating more depressive symptoms.	1-month
Secondary	World Health Organization Quality of Life Scale (WHOQOL-Brief)	Scores range from 26-105 with higher scores indicating higher perceived quality of life.	1-month
Secondary	Patient Reported Outcomes Measurement Information system - Perceived Stress	Scores range from 10-50 with higher scores indicating higher levels of perceived stress	1-month