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NCT06510439 · ClinicalTrials.gov registry record · NA
Need to be Needed (N2BN) Intervention
A NA study of Loneliness and Social Isolation, sponsored by Temple University.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06510439 is a NA study of Loneliness and Social Isolation that is actively recruiting participants, run by Temple University. The registered enrollment target is 120 participants, below the 406-participant average among 35 other Loneliness trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06510439, a NA study of Loneliness and Social Isolation, is actively recruiting participants, sponsored by Temple University.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness (SMI). The intervention will focus on improving their sense of mattering by using acts of kindness and experiencing gratitude through volunteering. 120 participants will be randomly assigned to the intervention group or the attention control group. Over the course of the 6-month intervention, participants in the intervention arm, will receive weekly support from the interventionist. The interventionist and the participant will collaboratively set goals and develop an initial intervention plan, which is informed by the participants interests, values and goals. The attention control group will receive non-directive listening support through research assistants. Data collection for all participants will occur at baseline, at the mid-point of the intervention at 3 months, and at the end of the 6-month intervention. Participants will be asked questions about quality of experience, social context and satisfaction, mattering components, kindness, gratitude, and loneliness. We will gather data on demographic background, life transitions, social network characteristics, internalized stigma, neighborhood climate, depression, and trait measures of mattering and loneliness during intake and exit interviews. Additionally, participants of the intervention arm will be asked to provide feedback about the intervention.
Conditions Studied
Interventions
- BEHAVIORAL Need to Be Needed Intervention
- OTHER Active Control Group
Study Locations (1)
Pennsylvania
- Hall Mercer - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-10-07 |
| Est. Completion | 2035-05-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06510439
The ClinicalTrials.gov registry entry for NCT06510439 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 406-participant average among 35 other Loneliness trials with a reported enrollment target (70% lower). The listed sponsor is Temple University, which has 163 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Loneliness appearing as the primary indexed condition, and to 2 interventions - of which Need to Be Needed Intervention is the first listed.
NCT06510439 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06510439 about?
NCT06510439 is a clinical study titled "Need to be Needed (N2BN) Intervention". The proposed study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness (SMI). The intervention will focus on improving their sense of mattering by using acts of kindnes...
What is the current status of trial NCT06510439?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2024-10-07. Estimated completion is 2035-05-31.
What conditions does trial NCT06510439 study?
This clinical trial studies the following conditions: Loneliness, Social Isolation.
What interventions are being tested in trial NCT06510439?
The interventions under investigation include: Need to Be Needed Intervention (BEHAVIORAL), Active Control Group (OTHER).
Who is sponsoring clinical trial NCT06510439?
This trial is sponsored by Temple University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06510439 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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