Need to be Needed (N2BN) Intervention
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Temple University
- Study ID
- NCT06510439
- Status
- Recruiting
Conditions
- Loneliness
- Social Isolation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Need to Be Needed Intervention — BEHAVIORALInterventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention.
- Active Control Group — OTHERWeekly non-directive listening support
Study Details
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 Dates
- Start date
- Oct 7, 2024
- Status verified
- Jan 2026
- Primary completion
- Jul 30, 2027
- Completion
- May 31, 2035
Study Design
- Enrollment
- 120 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Need to be Needed InterventionInterventionists will meet with participants to discuss supported volunteering concepts and develop an initial plan. This plan will be flexible as it is likely that participants will need multiple opportunities to identify and explore options for voluntarism. Once the plan is developed, interventionist will make weekly contact to support participants in achieving goals. These weekly contacts (3x per month) are expected to be brief (30-40 minutes) and focused on information sharing and supported problem solving. Interventionists will also schedule monthly plan reviews (1x per month) with participants to review and revise supported volunteering individualized plans. Both clients who are achieving goals as well as those falling short of their goals may want to revise or change their plan.
- Active Comparator: Active control groupParticipants assigned to the attention control condition will receive printed information on the importance and opportunities for volunteering and will be encouraged to review resources from the TU Collaborative website. They will receive weekly 10-minute non-directive supportive listening sessions via telephone/videoconferencing with a Research assistant. Research assistants are full-time staff members with an undergraduate degree in psychology. Undergraduate students are not involved in performing the weekly check-ins with the control group. The control group will not receive weekly 1:1 support through a trained clinician.
Primary Outcome Measure
Change of Demographic Background [ Time Frame: baseline, after 3-months, after 6-months ]
Central Contacts
- Bryan Mccormick, PhD1-215-204-6817
- Tabea Neumann, M.Sc
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Hall Mercer | Philadelphia | Pennsylvania | 19106 |
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