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

NCT07204444 | Completed Results

• 2 other identifiers: 90INNU0021-03-0090INNU0021
• Study Type: interventional
• Target: 671
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.How is this improvement manifested for particular aspects of mental health (i.e. depression, social needs, suicide desire, and overall quality of life)?
4. 4.answer questions from a trained data collector to get their baseline,
5. 5.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.

Conditions

Older Adults; Mental Health; Depression; Loneliness; Social Isolation; Suicide Ideations; Social Functioning; Quality of Life; Thwarted Belongingness; Perceived Burdensomeness; Help-Seeking Behavior; Suicide Risk

Keywords

mental health clinical trial for older adults

Outcome Measures

Primary Outcomes (6)

• Social Provisions Scale (SPS-5)

  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.

  Baseline, Week 2, Week 4, Week 6 and Week 8

• University of California, Los Angeles Loneliness Scale

  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.

  Baseline, Week 2, Week 4, Week 6 and Week 8

• Generalized Anxiety Disorder (GAD-7)

  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).

  Baseline, Week 2, Week 4, Week 6, Week 8

• Patient Health Questionnaire - PHQ-9

  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).

  Baseline, Week 2, Week 4, Week 6 and Week 8

• Short Form Health Survey (SF-12)

  The Short Form Health Survey (SF-12) is a self-reported outcome measure to assess health-related quality of life. The raw answers from the 12 questions are processed to produce two main, standardized summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). We only used the MCS factor in this study as the treatment is targeting mental health. The MCS computed score has a range from 17 to 64 in the analysis and was based on the linear combination of six computed, generated, iterated weights. A low Mental Component Summary (MCS) score indicates poorer self-perceived mental health and lower health-related quality of life.

  Baseline, Week 2, Week 4, Week 6 and Week 8

• Interpersonal Needs Questionnaire (INQ-15)

  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.

  Baseline, Week 2, Week 4, Week 6 and Week 8

Secondary Outcomes (1)

• Session Rating Scale

  Baseline, Week 2, Week 4, Week 6 and Week 8

Study Arms (3)

BE Condition

EXPERIMENTAL

The BE condition which involves receiving treatment from providers trained to foster belongingness and empathy, grounded in the befriending literature (Wiles et al., 2019; Fakoya et al., 2021), and narrative reminiscence (Yousefi, 2015). Aging Network Providers trained in BE provide a "small dose of sincere connection" through 5 core components: 1. reciprocity: the feeling that both parties are benefiting 2. intimacy: willingness to share deeply (superficial sharing at first helps build the relationship, but deeper sharing is what leads to positive outcomes) 3. reliability \& respect (calling at the time you say you are going to call creates consistency and reliability, and that the older adult matters 4. proximity: feeling more connected to people within your community 5. autonomy: feeling both parties are willingly participating with each connection

Behavioral: standardized and manualized warm calls from providers trained in the BE training

BE + ASIST Condition

EXPERIMENTAL

The BE + ASIST condition includes the BE training + the aging variant of LivingWorks ASIST (Applied Suicide Intervention Skills Training; Lang et al., 2013). Analogous to CPR, paraprofessionals can learn "suicide first aid." Providers trained in ASIST are equipped to do a 6 step model (Pathway for Assisting Life (PAL)) to help stabilize a person at risk of suicide at the moment it needed the most. The PAL model matches six needs of the older adult-at-risk with six tasks of the treatment provider. These include (1) exploring invitations (i.e. voluntary stopping of eating and drinking, withholding medical treatment, etc.), 2. asking directly about suicide, 3. sincerely hearing the story about suicide, 4. working effectively with ambivalence about dying, and offering a 3rd option (to stay safe for now), 5. developing a mutually endorsed safety plan, and 6. confirming actions (asking the older adult to repeat the plan back to the provider)

Behavioral: standardized and manualized warm calls from providers trained in the BE training + ASIST training

Control

NO INTERVENTION

participants randomized to this condition will not receive call dosages during the clinical trial. However, they will have the option to receive call dosages after the 8 weeks have concluded.

Interventions

standardized and manualized warm calls from providers trained in the BE training BEHAVIORAL

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

BE Condition

standardized and manualized warm calls from providers trained in the BE training + ASIST training BEHAVIORAL

Weekly call dosages averaging 20-30 minutes each, for 8 weeks duration

BE + ASIST Condition

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of verbal informed consent,
• Classify as an Older Adult (55+),
• Stated willingness and ability to comply with all study procedures,
• Receive nutrition services through the Aging Services Network (i.e. either HDM (home delivered meals services) or CM (congregate meals)), and
• Be affiliated with one of the 25 senior centers we will contract with through a Memorandum of Understanding.
• Provision of written informed consent,
• State willingness to comply with all study procedures,
• Be a staff or volunteer within the ASN (Aging Services Network), specifically within the 25 senior centers we are working with,
• Meet criteria identified by Wymann and colleagues (2009) for being a "natural helpers" (i.e. be warm, empathic, and having ongoing interaction with participants through one's job role), and
• Be recommended by the senior center leadership as meeting these qualifications.

You may not qualify if:

• Had a dementia diagnosis, or another form of cognitive impairment, and/or hearing impairment that would preclude phone conversation, and
• Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.
• The reasons given to exclude participants with dementia/cognitive impairment diagnoses from large-scale clinical research are partially related to the concern of a potential risk of abuse and exploitation. Further, those with cognitive impairment are not able to give informed consent, and there are measurement challenges with behavioral health data.
• Does not have ongoing interactions with potential old adult participants (i.e. is a part of an optimized nutrition service provider in which they do not serve the same older adults consistently over time), and
• Participation in another warm calling behavioral treatment or intervention study simultaneously occurring in this state.

Sponsors & Collaborators

• University of Florida: lead
• Georgia State University: collaborator
• Department of Health and Human Services: collaborator

Study Sites (1)

Older Adults' Homes; Treatment Provided Over the Phone

Atlanta, Georgia, 30318, United States

Location

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MeSH Terms

Conditions

Psychological Well-Being; Depression; Social Isolation; Social Adjustment; Help-Seeking Behavior

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Social Behavior

Results Point of Contact

• Title: Laura R. Shannonhouse, PhD
• Organization: University of Florida

lshannonhouse@coe.ufl.edu

352-273-4332

Study Officials

• Laura R Shannonhouse, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Methodologist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: June 1, 2021
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: November 12, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)