The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)

Not Applicable

Completed

• Conditions: Older Adults; Mental Health; Depression; Loneliness; Social Isolation; Suicide Ideations; Social Functioning; Quality of Life; Thwarted Belongingness; Perceived Burdensomeness

• Registration Number: NCT07204444
• Lead Sponsor: University of Florida

Brief Summary

The goal of this clinical trial is to learn if the BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation delivered to older adults improves their mental health. It will also learn about the treatment components that led to improvements. The main questions it aims to answer are:

1. Over the course of the 8 week standardized and manualized warm calling treatment, are mental health outcomes improved for the BE and BE + ASIST (Applied Suicide Intervention Skills Training) treatment conditions relative to a control group?

2. Are there differential outcomes for older adults who start the treatment at low, medium, or high risk? (as defined by a baseline aggregate of measures)?

3. How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)?

Participants will:

1. answer questions from a trained data collector to get their baseline,

2. receive 8 weeks of warm calls for 2 months (if assigned to one of the 2 treatment conditions, if assigned to control they will have the option to receive treatment at a later time), and (c) be assessed every 2 weeks.

Detailed Description

This study is a partially nested randomized controlled trial research design (PN-RCT) with a two-level structure of clients (level-1) nested within callers (level-2) for the two treatment conditions which receive calls. Given that outcomes for older adults receiving calls from the same treatment provider may be more similar than for those who receive calls from a different provider, the use of multilevel modeling can account for these data dependencies. We will be investigating 1) how our BE WITH (Belonging through Empathy With Intentional Targeted Helping) innovation reduces social isolation, loneliness, and elevated suicidality among home delivered meal and former congregate meal clients and improves their social support and well-being. Social isolation, loneliness, and elevated suicidality will be operationalized through a combination of validated psychometric measures taken before, during, and after the structured 8-week intervention. For older adults receiving calls, data from validated measures will be triangulated with behavioral observations of the older adults' emotional states based upon a structured analysis of recorded audio files. We hypothesize that older adults in both treatment conditions will have reduced: social isolation, loneliness, depression, mental health distress, and suicide desire; and they will have increased: social connection, social support, and well-being over time and in comparison to those in the control condition. We will also investigate 2) how BE WITH improves the frequency of empathic and suicide intervention best practice behaviors by trained nutrition service providers. This will be demonstrated in both real-world settings and in situations where a research confederate presents a clinically heightened risk of social isolation, loneliness, and elevated suicidality. Evaluation of counseling skills and suicide intervention skills is challenging, as observations of caregivers working with clients are required. We hypothesize that those trained in both conditions will demonstrate positive global counseling behaviors; however, those trained in BE WITH will more often employ suicide intervention practices when needed.

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2024-10-25
• Study Completion: 2024-10-25
• Status Verified: 2025-06
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 671

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Social Provisions Scale (SPS-5)	Baseline, Week 2, Week 4, Week 6 and Week 8	The Social Provisions Scale (SPS-5) is a 5-item measure used to evaluate a participant's level of social support. It is a shortened version of the 10-item SPS and designed for use in research studies to reduce participant burden while maintaining strong psychometric properties. The SPS is based on a theory of social support developed by Irwin Weiss and uses one positive item to assess the social provisions of Attachment, Guidance, Social Integration, Reliable alliance, and Reassurance of worth. Each item is rated on a 4-point Likert scale, from "Strongly Disagree" to "Strongly Agree". Sample items include, "There is someone I could talk to about important decisions in my life", "I feel part of a group of people who share my attitudes and beliefs", and "There are people I can count on in an emergency." A total score is calculated by summing the responses to the 5 questions. The scores can range from 5 to 20, with higher scores indicating higher levels of perceived social support.
University of California, Los Angeles Loneliness Scale	Baseline, Week 2, Week 4, Week 6 and Week 8	The three-item UCLA Loneliness Scale (Hughes et al., 2004) is a widely used instrument for measuring subjective feelings of loneliness. The scale assesses three core dimensions of loneliness through corresponding items: relational connectedness ("How often do you feel that you lack companionship?"), social connectedness ("How often do you feel left out?"), and self-perceived isolation ("How often do you feel isolated from others?"). Participants respond using a 3-point scale ranging from "hardly ever" to "often." Total scores range from 3 to 9, with higher scores indicating greater loneliness. The scale demonstrates good psychometric properties in middle-aged and older adult populations.
Generalized Anxiety Disorder (GAD-7)	Baseline, Week 2, Week 4, Week 6, Week 8	The GAD-7 is a 7-item questionnaire designed to assess the symptoms of Generalized Anxiety Disorder (GAD). Each item describes a common GAD symptom and is rated on a four-point scale (0-3) based on how often the individual has experienced that symptom over the past 2 weeks. The 7 questions assess feelings such as nervousness, inability to control worrying, trouble relaxing, restlessness, irritability, and feeling afraid. Sample items include, "how often have you felt nervous, anxious, or on edge", "how often have you worried too much about different things", "how often have you had trouble relaxing", and "fFelt afraid as if something awful might happen." Total scores range from 0 to 21, with higher scores indicating increased anxiety severity. Scores are categorized as: 0-4 (minimal anxiety), 5-9 (mild anxiety), 10-14 (moderate anxiety), and 15-21 (severe anxiety).
Patient Health Questionnaire - PHQ-9	Baseline, Week 2, Week 4, Week 6 and Week 8	The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure to assess depressive symptoms in the past 2 weeks (Kroenke et al., 2001). The scale items correspond to the 9 diagnostic criteria for major depressive disorder. Respondents rate the frequency of each symptom on a 4-point scale ranging from "not at all" to "nearly every day." Sample items include "Little interest or pleasure in doing things" and "Poor appetite or overeating." Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. The PHQ-9 includes an additional functional impairment item that assesses how much the problems have affected the respondents' daily activities. The scale has shown strong psychometric properties across diverse populations. Among U.S. older adults, the PHQ-9 showed high sensitivity (88%) and specificity (80%) for identifying major depression, as well as the combination of major and minor depression (Phelan et al., 2010).
5. Short Form Health Survey (SF-12)	Baseline, Week 2, Week 4, Week 6 and Week 8	The SF-12 is a self-reported outcome measure to assess health-related quality of life (Ware et al., 1996). There are 2 main summary scores: Physical Component Summary (PCS): Reflects physical health, and Mental Component Summary (MCS): Reflects mental health. We only used the MCS factor in this study as the treatment is targeting mental health. Sample MCS items include "did you accomplish less than you would have liked as a result of any emotional problems (such as feeling depressed or anxious)", did you perform your work or other activities less carefully than usual as a result of any emotional problems (such as feeling depressed or anxious).?", "how much of the time has your physical health or feelings interfered with your social activities?", "have you felt calm or peaceful", "have you felt downhearted and blue?", etc.
Interpersonal Needs Questionnaire (INQ-15)	Baseline, Week 2, Week 4, Week 6 and Week 8	The Interpersonal Needs Questionnaire (INQ; Van Orden et al., 2012) was used to evaluate thwarted belongingness and perceived burdensomeness through 15 items. We used an adapted version tailored specifically for older adults which includes 3-point Likert scale ranging from 1 (Not at all true for me) to 3 (Very true for me). The instrument includes 2 sets of characteristics: (1) the 9-item Thwarted Belongingness (e.g., "I feel disconnected from other people."); and (2) the 6-item Perceived Burdensomeness (e.g., "I think my death would be a relief to the people in my life."). Six questions from the Thwarted Belongingness subscale were reverse-coded when the overall score across questions was computed due to the nature of those questions. In particular, the total score on the INQ is calculated by summing the questions responses to all items and reversing the appropriate ones. As a result, greater scores on each subscale reflect higher levels of the respective construct being measured.

Secondary Outcome Measures

Name	Time	Method
Session rating scale	Baseline, Week 2, Week 4, Week 6 and Week 8	The 4-item Session Rating Scale (SRS; Duncan et al., 2003) is a therapeutic practice measure that treatment recipients complete after receiving treatment.This allows trained helpers to make real-time adjustments to improve treatment effectiveness and prevent dropout. The SRS is a practical tool for tracking treatment progress and ensuring the best possible care. Benefits of using the SRS is the ability to receive Real-Time Feedback, Improved Client Outcomes; Prevention of Dropouts; and build working alliance. Sample items include, "Did you feel heard, understood, and respected by the volunteer?"). Participants marked their responses on a Likert-Scale, ranging from 0 to 10, representing: (a) the quality of the therapeutic relationship, (b) agreement on goals and topics, (c) the relevance and fit of the treatment provider's approach, and (d) the overall effectiveness of the treatment dosage. The scores for each domain were summed to generate a total score.

Trial Locations

Locations (1)

Older Adults' Homes; Treatment Provided Over the Phone; 🇺🇸 Atlanta, Georgia, United States