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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: Recruiting NA study of Loneliness and Social Isolation, sponsored by Temple University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status
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 |
What NCT06510439 shows while recruiting
NCT06510439 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 406-participant average among 35 other Loneliness trials with a reported enrollment target (70% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Loneliness
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 NCT06510439's enrollment target sits among peer trials
120 17th of 35 higher than 19 of 35 other Loneliness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Loneliness 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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