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

NCT07204444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 671

Last updated 2025-11-12

Study results available
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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.

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

Interventions

BEHAVIORAL

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

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

BEHAVIORAL

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

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

Sponsors & Collaborators

  • Georgia State University

    collaborator OTHER

  • Department of Health and Human Services

    collaborator FED

  • University of Florida

    lead OTHER

Principal Investigators

  • Laura R Shannonhouse, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2024-10-25
Completion
2024-10-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07204444 on ClinicalTrials.gov