Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-07-30
Study Completion Date
2024-07-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Loneliness
Social Isolation
Study Design
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Allocation Method
NA
Intervention Model
PARALLEL
Following the production of the refined/modified CSI, a RCT will be initiated to assess the efficacy of the CSI intervention relative to a Health Education Training (HET) control group.
Approximately 50 participants will be randomly assigned to one of two conditions (1) CSI or (2) HET Control. Consistent with the rationale of an Indicated clinical trial, the primary entry criteria will be age (\>65) as well as above average levels of loneliness (primary outcome). Participants will be assessed on a range of relevant outcome measures at pretreatment, post-treatment, and 1-month follow-ups. There are three interrelated study hypotheses (see Aim 2 above):
1. CSI will significantly reduce loneliness relative to control.
2. CSI will positively impact other outcomes such as quality of life during the follow-up period relative to control.
3. Intervention related changes in risk (PB/TB) will mediate the relationship between CSI and outcomes (loneliness) at follow-up.
Approximately 50 participants will be randomly assigned to one of two conditions (1) CSI or (2) HET Control. Consistent with the rationale of an Indicated clinical trial, the primary entry criteria will be age (\>65) as well as above average levels of loneliness (primary outcome). Participants will be assessed on a range of relevant outcome measures at pretreatment, post-treatment, and 1-month follow-ups. There are three interrelated study hypotheses (see Aim 2 above):
1. CSI will significantly reduce loneliness relative to control.
2. CSI will positively impact other outcomes such as quality of life during the follow-up period relative to control.
3. Intervention related changes in risk (PB/TB) will mediate the relationship between CSI and outcomes (loneliness) at follow-up.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
Participants will be randomized to receive either control or intervention condition and they will be blind to which condition they are receiving.
Study Groups
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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.
Group Type
PLACEBO_COMPARATOR
Health Education Training
Intervention Type
BEHAVIORAL
Control condition where participants learn about healthy lifestyle behaviors.
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.
Group Type
ACTIVE_COMPARATOR
Combatting Social Isolation
Intervention Type
BEHAVIORAL
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
Health Education Training
Control condition where participants learn about healthy lifestyle behaviors.
Intervention Type
BEHAVIORAL
Other Intervention Names
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Control
Eligibility Criteria
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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).
* 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.
* Participants who change medications or initiate psychotherapy during the follow-up interval will be evaluated separately and potentially excluded from the main analyses.
Minimum Eligible Age
60 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Retirement Research Foundation
OTHER
Sponsor Role
collaborator
Florida State University
OTHER
Sponsor Role
lead
Responsible Party
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Norman Schmidt
Distinguished Research Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Norman B Schmidt, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Florida State University
Locations
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Anxiety and Behavioral Health Clinic
Tallahassee, Florida, United States
Site Status
Countries
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United States
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00003135
Identifier Type: -
Identifier Source: org_study_id
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