Skip to content

Reducing Isolation and Feeling of Loneliness During Critical Illness

Reducing Isolation and Loneliness in Patients With Critical Illness With Novel Engagement Strategies: a Pilot Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05537311
Acronym
SOCIAL
Enrollment
13
Registered
2022-09-13
Start date
2022-07-27
Completion date
2023-07-01
Last updated
2023-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Critical Illness, Depression, Post Intensive Care Unit Syndrome, Social Isolation

Keywords

critical illness, Post Intensive Care Unit Syndrome, social isolation

Brief summary

The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.

Detailed description

Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone. Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: I felt like I was being held captive in an unknown basement. Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).

Interventions

BEHAVIORALSocial Engagement

30-45 minutes of social engagement provided to patients in ICU. Social engagement strategies including meaningful conversation, cognitive stimulation, and emotional support

Sponsors

Kirby Mayer
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor will be blinded to treatment group

Intervention model description

pilot-randomized trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* adult * admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)

Exclusion criteria

* previous cognitive or emotional health condition * inability to follow commands

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of implementing the study interventionThrough completion of the intervention, which on average will occur one week after randomizationDetermine the number of sessions delivered per number of sessions scheduled. The study sample size of 12 subjects to receive the intervention, and each subject in the intervention should receive 5 sessions each = 60 sessions total; success will be considered 75% of sessions delivered (45 sessions completed of 60 planned).
Safety of the study intervention defined as number of patients with treatment-related adverse eventThrough completion of the intervention, which on average will occur one week after randomizationMinor adverse events, major adverse events, and unanticipated problems as assessed by the investigators per study protocol will be recorded during each treatment session. The rate of adverse events will be examined.

Secondary

MeasureTime frameDescription
Self-reported anxietyThrough study completion, which will occur on average 1-3 months after hospital dischargeHospital Anxiety and Depression Scale - Anxiety- self report questionnaire with higher scores indicating worse perceived anxiety
Self-reported depressionThrough study completion, which will occur on average 1-3 months after hospital dischargeHospital Anxiety and Depression Scale - Depression - self report questionnaire with higher scores indicating worse perceived depression
Self-reported health related quality of lifeThrough study completion, which will occur on average 1-3 months after hospital dischargeEurQol-5Domain (EQ-5D) - self report questionnaire with higher scores indicating better perceived quality of life
Cognitive functionThrough study completion, which will occur on average 1-3 months after hospital dischargeMontreal Cognitive Assessment - performed cognitive examination with higher scores indicating better cognitive function

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026