LonelinessCSINCT05426837
Combatting Social Isolation in Older Adults
A study testing Combatting Social Isolation and Health Education Training in people with Loneliness and Social Isolation, run by Florida State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loneliness, Social Isolation
- What is being tested?
- Combatting Social Isolation and Health Education Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Anxiety and Behavioral Health Clinic
Tallahassee, Florida, 32306
About this study
Official title: 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.
Read the detailed description
The study design involves protocol refinement and clinical trial evaluation phases:
- 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).
- 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
- Loneliness, Social Isolation
- Being tested
- Combatting Social Isolation, Health Education Training
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combatting Social IsolationBehavioural
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 TrainingBehavioural
Also called Control
Control condition where participants learn about healthy lifestyle behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Health Education Training | Placebo comparator | 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. Receives: Behavioral: Health Education Training |
| Combatting Social Isolation | Active comparator | 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. Receives: Behavioral: Combatting Social Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
University of California Los Angeles Loneliness Scale
Scores range from 20-80 with higher scores indicating higher levels of loneliness.
Measured: 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
Measured: 1-month
Secondary outcomes (5)
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.
Measured: 1-month
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Scores range from 8-40 with higher scores indicating more anxiety symptoms.
Measured: 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.
Measured: 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.
Measured: 1-month
Patient Reported Outcomes Measurement Information system - Perceived Stress
Scores range from 10-50 with higher scores indicating higher levels of perceived stress
Measured: 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start30 Jul 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (67)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Retirement Research Foundation
- Responsible party
- Principal investigator, Norman Schmidt, Florida State University
- Investigators
- Norman B Schmidt, Ph.D, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426837
- Sponsor's protocol ID
- STUDY00003135
- Acronym
- CSI
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2022
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make IPD available to other researchers
Publications
Berkman LF, Glass T, Brissette I, Seeman TE. From social integration to health: Durkheim in the new millennium. Soc Sci Med. 2000 Sep;51(6):843-57. doi: 10.1016/s0277-9536(00)00065-4.
PubMed 10972429Beland F, Zunzunegui MV, Alvarado B, Otero A, Del Ser T. Trajectories of cognitive decline and social relations. J Gerontol B Psychol Sci Soc Sci. 2005 Nov;60(6):P320-P330. doi: 10.1093/geronb/60.6.p320.
PubMed 16260706Aylaz R, Akturk U, Erci B, Ozturk H, Aslan H. Relationship between depression and loneliness in elderly and examination of influential factors. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):548-54. doi: 10.1016/j.archger.2012.03.006. Epub 2012 Apr 8.
PubMed 22487148Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249Brummett BH, Barefoot JC, Siegler IC, Clapp-Channing NE, Lytle BL, Bosworth HB, Williams RB Jr, Mark DB. Characteristics of socially isolated patients with coronary artery disease who are at elevated risk for mortality. Psychosom Med. 2001 Mar-Apr;63(2):267-72. doi: 10.1097/00006842-200103000-00010.
PubMed 11292274Cacioppo JT, Hawkley LC, Crawford LE, Ernst JM, Burleson MH, Kowalewski RB, Malarkey WB, Van Cauter E, Berntson GG. Loneliness and health: potential mechanisms. Psychosom Med. 2002 May-Jun;64(3):407-17. doi: 10.1097/00006842-200205000-00005.
PubMed 12021415Cacioppo JT, Hawkley LC. Social isolation and health, with an emphasis on underlying mechanisms. Perspect Biol Med. 2003 Summer;46(3 Suppl):S39-52.
PubMed 14563073Cacioppo JT, Hughes ME, Waite LJ, Hawkley LC, Thisted RA. Loneliness as a specific risk factor for depressive symptoms: cross-sectional and longitudinal analyses. Psychol Aging. 2006 Mar;21(1):140-51. doi: 10.1037/0882-7974.21.1.140.
PubMed 16594799Cacioppo S, Grippo AJ, London S, Goossens L, Cacioppo JT. Loneliness: clinical import and interventions. Perspect Psychol Sci. 2015 Mar;10(2):238-49. doi: 10.1177/1745691615570616.
PubMed 25866548Sander R. Preventing social isolation and loneliness among older people: a systematic review of health promotion interventions. Nurs Older People. 2005 Mar 1;17(1):40. doi: 10.7748/nop.17.1.40.s11.
PubMed 27736564Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Cella D, Yount S, Rothrock N, Gershon R, Cook K, Reeve B, Ader D, Fries JF, Bruce B, Rose M; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS): progress of an NIH Roadmap cooperative group during its first two years. Med Care. 2007 May;45(5 Suppl 1):S3-S11. doi: 10.1097/01.mlr.0000258615.42478.55.
PubMed 17443116Cohen S, Doyle WJ, Skoner DP, Rabin BS, Gwaltney JM Jr. Social ties and susceptibility to the common cold. JAMA. 1997 Jun 25;277(24):1940-4.
PubMed 9200634Cohen-Mansfield J, Perach R. Interventions for alleviating loneliness among older persons: a critical review. Am J Health Promot. 2015 Jan-Feb;29(3):e109-25. doi: 10.4278/ajhp.130418-LIT-182.
PubMed 24575725Cornwell EY, Waite LJ. Measuring social isolation among older adults using multiple indicators from the NSHAP study. J Gerontol B Psychol Sci Soc Sci. 2009 Nov;64 Suppl 1(Suppl 1):i38-46. doi: 10.1093/geronb/gbp037. Epub 2009 Jun 9.
PubMed 19508982
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combating Social Isolation in Older Adults: Randomized Clinical Trial Evaluating the Acceptability and Efficacy of a Brief, Technology Delivered Intervention
- ClinicalTrials.gov ID
- NCT05426837
- Acronym / sponsor ID
- CSI / STUDY00003135
- Conditions
- Loneliness, Social Isolation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Retirement Research Foundation
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study design involves protocol refinement and clinical trial evaluation phases:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Health Education Training | Placebo comparator | Behavioral: Health Education TrainingHealth 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. |
| Combatting Social Isolation | Active comparator | Behavioral: Combatting Social IsolationCombating 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combatting Social IsolationA 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. | Behavioural | Combatting Social Isolation |
| Health Education TrainingAlso: ControlControl condition where participants learn about healthy lifestyle behaviors. | Behavioural | Health Education Training |
Primary outcome
University of California Los Angeles Loneliness Scale
Time frame: 1-month
Scores range from 20-80 with higher scores indicating higher levels of loneliness.
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
5 secondary outcomes
Berkman Social Network Inventory
Time frame: 1-month
Patient Reported Outcomes Measurement Information System - Anxiety Short Form
Time frame: 1-month
Patient Reported Outcomes Measurement Information System - Emotional Distress-Depression-Short Form
Time frame: 1-month
World Health Organization Quality of Life Scale (WHOQOL-Brief)
Time frame: 1-month
Patient Reported Outcomes Measurement Information system - Perceived Stress
Time frame: 1-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
- Background: PubMed 10972429Berkman LF, Glass T, Brissette I, Seeman TE. From social integration to health: Durkheim in the new millennium. Soc Sci Med. 2000 Sep;51(6):843-57. doi: 10.1016/s0277-9536(00)00065-4.
- Background: PubMed 16260706Beland F, Zunzunegui MV, Alvarado B, Otero A, Del Ser T. Trajectories of cognitive decline and social relations. J Gerontol B Psychol Sci Soc Sci. 2005 Nov;60(6):P320-P330. doi: 10.1093/geronb/60.6.p320.
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- Individual participant dataSharing planned: No. No plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman B Schmidt, Ph.D principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combatting Social Isolation and Health Education Training in people with Loneliness and Social Isolation, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
University of California Los Angeles Loneliness Scale (time frame: 1-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426837, which also lists 67 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2025.