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Need to be Needed (N2BN) Intervention

Study acronym: N2BN RCT
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jul 2027 to Jul 30, 2027
    • Study completion date: May 2035 to May 31, 2035
    • Start date changed from estimate of Sep 2024 to Oct 7, 2024
    • Study description revised
  2. Notable Start date: Jul 2024 to Sep 2024
    • Interventions: Need to Be Needed Intervention (Behavioral) to Active Control Group (Other), Need to Be Needed Intervention (Behavioral)
    • Study description shortened, about 30 words
    • Publications expanded, about 192 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06510439
Lead Sponsor Temple University
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions
(from sponsor)
Loneliness, Social Isolation
Related terms Social Isolation
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov