Need to be Needed (N2BN) Intervention

Recruiting now · Not applicable

Conditions studied: Loneliness, Social Isolation

In brief

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.

Key facts

Study ID

NCT06510439

Run by

Temple University

People needed

120

Starts

2024-10-07

Expected to finish

2035-05-31

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A research diagnosis of Major Depression, Bipolar I, II, or Schizophrenia Spectrum disorder.
• Participants will be screened by research staff using sections of the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) that will identify research diagnoses of: Major Depression, Bipolar I, II, or Schizophrenia Spectrum disorder.
• Ages 18 years old and older
• Living in the community
• Able to communicate in written and oral English
• UCLA-Loneliness Scale score of 6 or higher

You may not qualify if…

• Having a legal guardian
• Unable to give informed consent.
• Living situation which restricts their ability to move freely
• Potential participants failing to meet screening criteria will be informed at the time that we are not able to enroll them in the study at this time. Any interview notes, or information recorded on the MINI will be destroyed or securely deleted.
• The study will not enroll any vulnerable populations.

Where it is running

• Hall Mercer — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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