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Combatting Social Isolation for Loneliness (CSI Trial)

N/A

Recruiting

Led By Norman B Schmidt, Ph.D

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-month

Awards & highlights

CSI Trial Summary

This trial will test a new web-based intervention for loneliness and social isolation in older adults.

Who is the study for?

This trial is for older adults experiencing loneliness or social isolation who have stable access to text messages and have been on a consistent dose of any psychopharmacology or psychotherapy for at least 2 months. They must score above 5 on a specific loneliness scale. Those with significant medical conditions that impair understanding, or who change medications or start new psychotherapy during the study may be excluded.Check my eligibility

What is being tested?

The trial tests 'Combating Social Isolation' (CSI), a web-based intervention designed to reduce feelings of burdensomeness and thwarted belongingness in lonely older adults. It's brief, can be accessed online, and aims to improve mental health outcomes by reducing loneliness through structured activities.See study design

What are the potential side effects?

Since CSI is an educational and social facilitation intervention delivered via the internet, it does not involve medication; therefore, traditional physical side effects are not expected. However, participants might experience emotional discomfort while engaging with sensitive topics.

CSI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on a stable dose of my mental health medication and in psychotherapy for at least 2 months.

CSI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interpersonal Needs Questionnaire

University of California Los Angeles Loneliness Scale

Secondary outcome measures

Berkman Social Network Inventory

Patient Reported Outcomes Measurement Information System - Anxiety Short Form

Patient Reported Outcomes Measurement Information System - Emotional Distress-Depression-Short Form

+2 more

Other outcome measures

Schmidt Lab Acceptability Questionnaire

CSI Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Combatting Social IsolationActive Control1 Intervention

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 II: Health Education TrainingPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Florida State UniversityLead Sponsor

198 Previous Clinical Trials

30,641 Total Patients Enrolled

1 Trials studying Loneliness

67 Patients Enrolled for Loneliness

Retirement Research FoundationOTHER

9 Previous Clinical Trials

1,734 Total Patients Enrolled

Norman B Schmidt, Ph.DPrincipal InvestigatorFlorida State University

1 Previous Clinical Trials

28 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently taking part in this clinical research?

"Affirmative. Clinicaltrials.gov contains information verifying this clinical trial's active recruitment status, which began on July 30th 2022 and was last updated October 29th of the same year. This medical research is seeking 50 patients from 1 location to participate."

Answered by AI

Is this investigation currently accessible to participants?

"Affirmative. Details on clinicaltrials.gov indicate that this trial, which went public on July 30th 2021 is still recruiting volunteers. The study needs to find 50 patients from a single medical centre for participation in the experiment."

Answered by AI

What objectives are being pursued by this clinical trial?

"This study seeks to gauge the efficacy of a proposed medical intervention through the Interpersonal Needs Questionnaire (Van Order et al., 2012) over an approximate one-month period. Other secondary evaluation metrics include Berkman Social Network Inventory (Berkman & Syme, 1979), Patient Reported Outcomes Measurement Information System - Anxiety Short Form (Pilkonis et al., 2011), and World Health Organization Quality of Life Scale (WHOQOL-Brief)."

Answered by AI