The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain
Phase: NA
Conditions: Pain, Chronic, Loneliness
Sponsor: University of Nebraska

The Loneliness Epidemic Tailoring Interventions to Reduce Loneliness and Pain 
NCT05387447 
 
08-21-2023

Protocol 
Setting and Recruitment 
We will recruit participants: 1) direct referral from those with ethical access in independent 
or assisted and independent living facilities and 2) community and social media marketing. 
A copy of a letter of support will be uploaded from each senior retirement apartment. We 
will host informational sessions (PI, Co-Is, and study personnel) with question-and-answer 
periods at the facilities (in Omaha and Lincoln) to inform participants about the study. We 
will obtain permission from these facilities prior to placing flyers at any locations in the 
community and hosting study informational presentations. Interested individuals will 
undergo screening and enrollment. 
The sites where the study will be conducted are the participant's place of residence at the 
following locations: Aksarben Village Senior Apartments Trinity Courtyard Senior 
Apartments (both in Omaha, NE) Eastmont Senior Living Apartments and The Legacy 
Senior Living (all in Lincoln, NE). 
Screening 
Study personnel (Omaha and Lincoln) will screen interested potential subjects according 
to inclusion and exclusion criteria in the private residence. Those meeting eligibility will 
undergo informed consent. 
Inclusion: 1) men and women 60 years of age; 2) live alone (single-family home, 
independent, or assisted living); 3) self-report have experienced or currently experiencing 
musculoskeletal pain; and 4) wireless internet access via a broadband Internet 
connection. 
Exclusion: 1) memory loss as evidenced by poor performance on the Mini Cog; 2) inability 
to speak English; 3) prior study participation; 4) prior use or current use of a conversational 
voice assistant; and 5) not willing to engage with the voice assistant. 
Both UNMC and UNL personnel will conduct screening, enrollment, Alexa set-up with 
instructions and training, data collection, data analysis and interpretation. 
Enrollment and Randomization 
Once all participants are recruited and enrolled, participants will be randomly assigned 
with equal distribution to the conversational voice assistant-standard group (CVA-S) or the 
conversational voice assistant-enhanced loneliness routine treatment group (CVA-E). The 
study will be a 12-week randomized pilot trial. 

Study Groups 
Group 1. Conversational Voice Assistant Standard Loneliness Routine (CVA-S) Participants 
in the CVA-S group will receive an a priori set of evidence-based interactions to perform 
with the conversational voice assistant. The interaction dose will be 15 minutes performed 
once in the morning and once in the evening, at pre-set times. The participants will 1) do a 
meditation activity, 2) play an interactive trivia game, and 3) ask the assistant to tell a joke. 
Group 2. Conversational Voice Assistant Enhanced Loneliness Routine (CVA-ELR) 
Participants in the CVA-ELR group will receive personalized intervention activities based on 
individual preferences and personality. The interaction dose will be 15 minutes performed 
once in the morning and once in the evening, at pre-set times and as needed. After 
collection of post-intervention data, participants will be compensated for their time. 
Procedures 
An appointment will be scheduled to set up Alexa, review instructions, and perform data 
collection by study personnel (Omaha and Lincoln). The instructions for both groups will 
include basic training by study personnel (Omaha and Lincoln) on how to use the 
conversational voice assistant. Then review of the loneliness routine based on group 
assignment. Data will be collected at pre (baseline) and post intervention (after 12-weeks). 
Data 
Pain Severity and Pain Interference: Subjective pain will be measured using the Brief Pain 
Inventory Short form (BPI-SF). The instrument has nine questions that measure pain 
severity and pain interference with function. The severity questions assess pain 
numerically ranging from 0 no pain to 10 pain as bad as you can imagine; interference 
questions assess interference from 0 no interference to 10 completely interferes. Higher 
scores indicate higher severity or interference with 0 being none, 1-3 mild, 4-6 moderate, 7- 
10 severe. The BPI-SF has Cronbach alphas ranging from 0.86-0.96. 
Loneliness: Subjective social isolation and loneliness will be measured using the University 
of California Los Angeles, UCLA Loneliness Scale Version 3, a 20-item instrument with 
responses of never, rarely, sometimes, and always. There is no standard accepted score for 
identifying loneliness; higher scores reflect greater reported loneliness. The scale has 
established validity and reliability with Cronbach's alphas ranging from 0.85 to 0.94. 
Depression: Will be measured as it may interfere with pain and loneliness. We will use the 
Geriatric Depression Scale Short form. The instrument has 15 questions with higher scored 
indicating depression. 

Self-management of Pain: PROMIS Self-Efficacy for Managing Symptoms-SF-8: an eight- 
item tool that allows the subjects to report the level of confidence to manage/control their 
symptoms, to manage their symptoms in different settings (home, public place, an 
unfamiliar place), and to keep their symptoms from interfering with work, sleep, 
relationships, or recreational activities. 
Objective Use: We will securely access the participants voice assistant profiles and 
document the time stamps of intervention activities to assess frequency and length of use, 
type of uses, and routine completion rates with the standard and enhanced loneliness 
routines. 
Usability: Usability will be measured using the System Usability Scale. The 10 question 5- 
point Likert scale scores range from 0-100 and scores above 68 are above average. 
Personality Inventory: The Big Five Inventory is a 40-item assessment of general personality 
using the five-factor model Neuroticism (N), Extraversion (E), Openness to Experience (O), 
Agreeableness (A), and Conscientiousness (C). 

Statistical Analysis 
Descriptive statistics to calculate inferential results such as percentages, mean and 
standard deviations on demographic, health history, BPI-SF, UCLA Loneliness Scale, 
Geriatric Depression, and PROMIS Self-efficacy scores at baseline and after the 12-week 
intervention. 
We will compare the average questionnaire scores within and between the CVA-S and CVA- 
E groups. The Shapiro-Wilk test used to assess the normality of distributions for these 
variables. Given the significant results, indicating non-normal distributions from the 
Shapiro-Wilk test for these variables except baseline pain severity and post-study severity, 
Wilcoxon Signed-Rank non-parametric test was chosen for hypothesis testing of all 
variables except baseline pain severity and post-study severity, which were tested by 
paired-samples t-test. In addition, ANOVA tests were performed to compare the baseline 
scores of self-reported pain severity, pain interference, loneliness, depression, and self- 
efficacy between the CVA-S and the CVA-E groups. 
Mann-Whitney U test was employed to test differences between the standard and 
enhanced conditions in terms of routine initiation rates and SUS scores. Multiple 
regression analyses were conducted to explore the relationships between participants’ 
SUS scores, objective use of the routines with personality.