N/A
N=671
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
Older Adults · Mental Health · Depression · Loneliness · Social Isolation
Bottom Line
View on ClinicalTrials.gov: NCT07204444 ↗Enrolled (actual)
671
Serious AEs
3.1%
Results posted
Nov 2025
Primary outcome: Primary: Social Provisions Scale (SPS-5) — 16.88; 17; 17.16; 17.34 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- standardized and manualized warm calls from providers trained in the BE training (Behavioral); standardized and manualized warm calls from providers trained in the BE training + ASIST training (Behavioral)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Social Provisions Scale (SPS-5) |
16.88; 17; 17.16; 17.34; 17.51; 16.98 | — |
| PRIMARY University of California, Los Angeles Loneliness Scale |
5.131; 5.035; 4.697; 4.786; 4.702; 4.846 | — |
| PRIMARY Generalized Anxiety Disorder (GAD-7) |
4.919; 4.544; 4.433; 4.005; 4.074; 4.851 | — |
| PRIMARY Patient Health Questionnaire - PHQ-9 |
5.768; 5.404; 5.433; 5.077; 4.759; 5.342 | — |
| PRIMARY Short Form Health Survey (SF-12) |
44.02; 44.17; 44.24; 45.59; 45.56; 44.73 | — |
| PRIMARY Interpersonal Needs Questionnaire (INQ-15) |
19.06; 18.83; 18.59; 18.68; 18.36; 18.24 | — |
| SECONDARY Session Rating Scale |
38.65; 38.34; 38.86; 38.86; 38.92; 38.89 | — |
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.
Eligibility Criteria
Inclusion Criteria for older adult participants:
- 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.
Inclusion Criteria for trained providers:
- 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.
Exclusion Criteria for older adult participants:
- 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.
Exclusion Criteria for trained helpers:
- 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.
Data sourced from ClinicalTrials.gov (NCT07204444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.