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NCT07204444 · ClinicalTrials.gov registry record · NA
The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)
A NA study of Depression and Quality of Life, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 671
- Enrollment target
- 1
- Study location
NCT07204444: Completed NA study of Depression and Quality of Life, sponsored by University of Florida.
NCT07204444 is a NA study of Depression and Quality of Life that has completed, run by University of Florida. The registered enrollment target is 671 participants, below the 785-participant average among 679 other Depression trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07204444, a NA study of Depression and Quality of Life, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 671 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL 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
Study Locations (1)
Georgia
- Older Adults' Homes; Treatment Provided Over the Phone - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2021-06-01 |
| Est. Completion | 2024-10-25 |
| Phase | NA |
What the finished NCT07204444 record still lists
NCT07204444 is an interventional study that assigns participants to a tested intervention. The registered 671 participants enrollment target is mid-sized for trials with a published cap, below the 785-participant average among 679 other Depression trials with a reported enrollment target (15% lower).
The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which standardized and manualized warm calls from providers trained in the BE training is the first listed.
NCT07204444 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT07204444 about?
NCT07204444 is a clinical study titled "The BE WITH Project: A Partially Nested Randomized Control Trial (PN-RCT)". 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...
What is the current status of trial NCT07204444?
This trial is currently completed. It is a NA study. The enrollment target is 671 participants. The study started on 2021-06-01. Estimated completion is 2024-10-25.
What conditions does trial NCT07204444 study?
This clinical trial studies the following conditions: Depression, Quality of Life, Mental Health, Loneliness, Social Isolation.
What interventions are being tested in trial NCT07204444?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT07204444?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07204444 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07204444's enrollment target sits among peer trials
671 62nd of 679 higher than 618 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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