Combatting Social Isolation in Older Adults (CSI)

March 7, 2024 updated by: Norman Schmidt, Florida State University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Recruiting
        • Anxiety and Behavioral Health Clinic
        • Principal Investigator:
          • Norman B. Schmidt, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Health Education Training
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
Control condition where participants learn about healthy lifestyle behaviors.
Other Names:
  • Control
Active Comparator: Combatting Social Isolation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
University of California Los Angeles Loneliness Scale
Time Frame: 1-month
Scores range from 20-80 with higher scores indicating higher levels of loneliness.
1-month
Interpersonal Needs Questionnaire
Time Frame: 1-month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Berkman Social Network Inventory
Time Frame: 1-month
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
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Time Frame: 1-month
Scores range from 8-40 with higher scores indicating more anxiety symptoms.
1-month
Patient Reported Outcomes Measurement Information System - Emotional Distress-Depression-Short Form
Time Frame: 1-month
Scores range from 8-40 with higher scores indicating more depressive symptoms.
1-month
World Health Organization Quality of Life Scale (WHOQOL-Brief)
Time Frame: 1-month
Scores range from 26-105 with higher scores indicating higher perceived quality of life.
1-month
Patient Reported Outcomes Measurement Information system - Perceived Stress
Time Frame: 1-month
Scores range from 10-50 with higher scores indicating higher levels of perceived stress
1-month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schmidt Lab Acceptability Questionnaire
Time Frame: 1-month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

Retirement Research Foundation

Investigators

  • Principal Investigator: Norman B Schmidt, Ph.D, Florida State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00003135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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