Recruiting

Social Isolation Intervention

Sponsor:

Temple University

Code:

NCT06510439

Conditions

Loneliness

Social Isolation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Need to Be Needed Intervention

Active Control Group

Study Details

Brief 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

Loneliness

Social Isolation

Study ID

NCT06510439

Start date

Oct 7, 2024

Status verified date

Jan, 2026

Completion date

May 31, 2035

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Ages 18 years old and older
3. Living in the community
4. Able to communicate in written and oral English
5. UCLA-Loneliness Scale score of 6 or higher

Exclusion Criteria:

1. Having a legal guardian
2. Unable to give informed consent.
3. 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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Need to be Needed Intervention

Interventionists 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 group

Participants 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.

Interventions

Need to Be Needed Intervention

Interventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention.

Active Control Group

Weekly non-directive listening support

Primary outcome measure

  • Change of Demographic Background [ Time Frame: baseline, after 3-months, after 6-months ]
  • Change of Neighborhood Social Climate Scale from Housing Environment Survey [ Time Frame: baseline, after 3-months, after 6-months ]
  • Change of Social Network [ Time Frame: baseline, after 3-months, after 6-months ]
  • Change of sense of mattering [ Time Frame: baseline, after 3-months, after 6-months ]
  • Change of sense of loneliness [ Time Frame: baseline, after 3 months, after 6 months ]
  • Change of sense of loneliness [ Time Frame: baseline, after 3 months, after 6 months ]
  • Change of depressive symptoms [ Time Frame: baseline, after 3 months, after 6 months ]
  • Change of sense of emptiness [ Time Frame: baseline, after 3 months, after 6 months ]
  • Change of community participation [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of health outcome [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of perceived stigma [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of perceived acts of kindess [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of perceived gratitude [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of overall well being [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of recovery assessment [ Time Frame: Baseline, after 3 months, after 6 months ]
  • Change of social support [ Time Frame: Baseline, after 3 months, after 6 months ]

Central Contacts and Locations

Central contacts

Bryan Mccormick, PhD

1-215-204-6817bryan.mccormick@temple.edu

Tabea Neumann, M.Sc

tabea.neumann@temple.edu

Locations

Hall Mercer

Recruiting

Philadelphia, Pennsylvania, United States, 19106

Contacts

Steven Niederriter, MBA

215.829.5575steven.niederriter@pennmedicine.upenn.edu

More Information

Sponsor

Temple University

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

  • mattering
  • loneliness
  • social isolation
  • need to be needed
  • neededness
  • volunteering

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2026-01-21.