An interventional study of Need to Be Needed Intervention and Active Control Group in Loneliness and Social Isolation, sponsored by Temple University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Temple University · Not applicable, Interventional, and Treatment
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.
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) receiving community mental health services. Specifically, the intervention will focus on improving their sense of mattering by using acts of kindness, and experiencing gratitude through volunteering.
This intervention is based on evidence-based models and takes a different approach than many loneliness and social connectedness interventions. Using the CIVIC Framework and Mattering Wheel as a foundation, this intervention has the potential to develop relationships of equality and reciprocity that extend beyond the intervention period. This intervention also draws upon our own intervention research which utilized the Individualized Placement and Support model in a supported leisure intervention.
Participants will be randomly assigned to the intervention group or the attention control group. Those in the intervention arm receive weekly support of an interventionist leading the intervention which is based on the aforementioned frameworks and informed by the idiosyncratic experiences and values of the participant. The control group will receive weekly non-directive listening support through research assistants and printed information on the importance, skills, and opportunities for participation.
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. Participants will receive support through weekly meetings through the interventionist who will monitor their progress, assist with problem solving and facilitates changes as needed. The attention control group will receive weekly non-directive listening support through research assistants.
Recruitment will occur only in Philadelphia in collaboration with outpatient treatment service providers. Data collection for all participants will take occur at baseline, at the mid-point of the intervention at 3 months, and at the end of the 6-month intervention.
The overall objective of the current study is to evaluate the outcomes associated with the Need to be Needed intervention. This project aims to address the following research questions:
RQ1a. Is participation in the intervention associated with reductions in loneliness? RQ1b. Is participation in the intervention associated with reductions in social isolation? RQ2. Are improvements in intervention targets (mattering, kindness, gratitude) predictive of social isolation and loneliness outcomes? RQ3. Is the intervention acceptable to individuals with SMI? RQ4. Is the implementation of this intervention feasible?
Group Assignment
Once participants have completed the informed consent process and baseline data collection, they will immediately be randomly assigned either the intervention or control group. Randomization will be done in blocks of ten by assigned participant number (i.e., #1 to #120) to prevent runs and enhance the probability of creating comparable groups.
N2BN Intervention
The proposed Need to be Needed (N2BN) intervention is a 6-month, supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention. At the beginning of the intervention, the interventionist will work with the participant to explore interests and identify opportunities for volunteering. The exploration of interests and interest-based opportunities supports the participants' autonomy and maximizes the benefits of volunteering. Part of this exploration includes the identification of welcoming places using the tools developed by the Temple University Collaborative on Community Inclusion. Welcoming places will then be explored to determine whether there are opportunities for volunteering within those locations. Encouraging participants to volunteer in places where they already feel welcome may more rapidly facilitate engagement in volunteering and enhanced social connectedness.
The chosen volunteer location must provide opportunity for consistent and sustained participation. Participants will be encouraged and assisted by interventionist to identify a volunteer opportunity that would allow for at least weekly engagement. Once a location is identified, the interventionist will work with the participant to identify the necessary skills for volunteering in that role. Consistent with the IPS model, these skills will be practiced and refined while volunteering at the chosen site. Each week, the interventionist will meet with the participant to discuss the activities done while volunteering and how those activities contributed to the overall success of the program. Additionally, the interventionist will facilitate discussions about the people at the volunteer site and explore opportunities for relationship development.
Because kindness and gratitude contribute to increases in social connectedness, we will include opportunities to engage in and document acts of kindness and feelings of gratitude. Throughout the first half of the intervention, the participant will be encouraged to identify acts of kindness he or she engages in at the volunteer location. This could include the volunteer activity alone or may include random acts of kindness that the participant initiates (e.g., helping beyond the volunteer time, offering to help another volunteer with something, bringing someone a coffee 'just because,' among others).
Participants will then be encouraged to expand these acts of kindness to their broader community. This will start with opportunities to engage in random acts of kindness within ones' welcoming places and then move to other community locations and relationships. Participants will be encouraged to practice kindness within the four areas (I.e., community, commitments, relationships, and self) of the mattering wheel. This provides an opportunity for participants to 'add value' to multiple life domains.
In the last half of the intervention, participants will be introduced to the concept of gratitude and engaging in intentional expressions of gratitude. Many interventions use writing as a strategy to document and express gratitude. This includes letter writing, journaling, and writing social media posts. Similarly, this intervention will encourage participants to create a gratitude journal and also encourage participants to express their gratitude to others- via writing or other means of communication. Participants will be encouraged to focus their journaling on gratitude related to individuals with whom they have either developed relationships or interacted with during the course of the intervention. Similarly, participants will be encouraged to document and express gratitude within the four areas (I.e., community, commitments, relationships, and self) of the mattering wheel. This process allows participants to explore and document the 'value gained.' Additionally, the participant and interventionist will discuss how the feelings of gratitude may lead to additional acts of kindness or ways to give back to the relationship.
Throughout the intervention, the interventionist will work closely with the participant to develop an individualized supports plan. This may include developing a visual calendar to support engagement in the volunteer activities; identifying natural supports to encourage ongoing participation; or scheduling opportunities for touring the volunteer location prior to volunteering, among others. Many of these strategies were developed and used by our team when implementing a supported leisure intervention. Additionally, the interventionist will talk with the participant weekly about potential social connections and navigate strategies to nurture those potential relationships.
Intervention frequency, intensity and duration. Interventionists will meet with participants initially to discuss supported volunteering concepts and develop an initial plan. It is anticipated that this initial contact will require 2-3 hours of time and may occur in more than a single meeting. This plan will be flexible as it is likely that participants will need multiple opportunities to identify and explore options for voluntarism. Once the initial plan is developed, the interventionist will make weekly contact either in person or via telephone/videoconference 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. Over the course of the 6-month intervention, it is projected that interventionists will engage with participants numerous times, possibly up to 40-45 hours of contact. Based on the planned enrollment of 10 participants per month, with five randomized into the treatment condition, the maximum number of individuals who could be supported per FTE navigator would be 20 participants. This consumer/staff ratio is below what is typically seen in such services as supported employment or education.
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.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Need to Be Needed Intervention
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.
Other: Active Control Group
Interventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention.
Also known as: N2BN Intervention
Weekly non-directive listening support
Change of Demographic Background
Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status
Time frame: baseline, after 3-months, after 6-months
Change of Neighborhood Social Climate Scale from Housing Environment Survey
Neighborhood Social Climate Scale from Housing Environment Survey (HES) (Kloos \& Shah, 2009): This 12-item subscale from the HES includes questions related to housing type (independent, familial, group), social context (alone, partnered, with others), stability (the length lived at their current residence), and satisfaction with one's housing and neighborhood
Time frame: baseline, after 3-months, after 6-months
Change of Social Network
Social Network Generator (Pescosolido \& Wright, 2004): This instrument identifies important people connected with the respondent. Network size, composition, contact, closeness, reciprocity, changes will be quantified.
Time frame: baseline, after 3-months, after 6-months
Change of sense of mattering
Interpersonal Mattering Scale (Moschella \& Baynard, 2021; Elliott et al., 2004): This 12-item scale examines three dimensions of mattering, including awareness (a=.87), importance (a=.89), and reliance (a=86).
Time frame: baseline, after 3-months, after 6-months
Change of sense of loneliness
3-Item UCLA Loneliness Scale (Hughes, Waite, Hawkley, \& Cacioppo, 2004). This brief measure of loneliness has shown satisfactory reliability and validity in the measurement of overall loneliness. (this instrument is repeated from intake interview)
Time frame: baseline, after 3 months, after 6 months
Change of sense of loneliness
6-item DeJong Gierveld Loneliness Scale (De Jong Gierveld \& van Tilburg, 2006) This 6-item measure is used to create a unidimensional overall loneliness measure as well as provide information about the emotional and/or social loneliness situation of respondents. Social loneliness reflects dissatisfaction with social relationships, whereas emotional loneliness represents dissatisfaction with a close discussion partner. (this instrument is repeated from intake interview)
Time frame: baseline, after 3 months, after 6 months
Change of depressive symptoms
Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977): This is a 20-item scale of depressive symptoms covering the prior week. a= .85-.90
Time frame: baseline, after 3 months, after 6 months
Change of sense of emptiness
The Psychological Emptiness Scale (PES) Herron et al., (2024) This instrument is a 19-item scale to measure the subjective experience of the sense of emptiness over the past month.
Time frame: baseline, after 3 months, after 6 months
Change of community participation
Temple University Community Participation Measure (TUCP). This measure records self-reports of community participation in 26 different areas including going to a supermarket, participating in a community social group (like a book club or recreational sports team), going to a movie, or working for pay. Participants are asked to indicate the number of days in the past 30 days that they participated in each of the 26 areas, whether each participation area was important to them, and whether they felt they participated in each area enough, not enough, or too much. Recent research has found the measure to be reliable and valid.
Time frame: Baseline, after 3 months, after 6 months
Change of health outcome
PROMIS® Scale v1.2 - Global Health- Patient Reported Outcome Measurement Information System (PROMIS) Global Health v1.2 short form is a 10-item instrument representing multiple domains. Scores are assigned for both Global Physical Health component and Global Mental Health component.
Time frame: Baseline, after 3 months, after 6 months
Change of perceived stigma
Internalized Stigma of Mental Illness scale (ISMI-10) (Hammer \& Toland, 2017): Internalized stigma will be assessed via this 10-item measure that has demonstrated adequate internal consistency, reliability and external validity. The ISMI-10 was found to have a good internal consistency reliability of 0.75.
Time frame: Baseline, after 3 months, after 6 months
Change of perceived acts of kindess
Kindness Measure (Young, et al., 2021): Created as a 20-item measure to assess the amount and variety of kindness a person exhibits. Contains subscales of a) affective-socially prescribed, b) anthropophobia, c) affective-proactive, d) principle-socially prescribed, and e) principle-proactive (subscale internal consistency .68-.95).
Time frame: Baseline, after 3 months, after 6 months
Change of perceived gratitude
Gratitude Questionnaire (GQ-6) (McCullough et al., 2002)- The Gratitude Questionnaire-Six-Item Form (GQ-6) is a six-item self-report questionnaire designed to assess individual differences in dispositional gratitude in daily life. Respondents endorse each item on a 7-point Likert-type scale (where 1 = strongly disagree and 7 = strongly agree), with two items negatively worded. It demonstrates good internal reliability with alphas between .82 and .87.
Time frame: Baseline, after 3 months, after 6 months
Change of overall well being
Overall Well Being PERMA Profile (Butler \& Kern, 2016) This instrument is a brief 23-item measure of overall well-being and examines positive emotion, engagement, relationships, meaning and accomplishment, as well as negative emotion and perceived health. The instrument has demonstrated good psychometric properties in large-scale studies with adults. This measure will support identification of important relationships; however, additional domains can be examined in relation to engagement and purpose in life.
Time frame: Baseline, after 3 months, after 6 months
Change of recovery assessment
Recovery Assessment Scale (RAS-20): assesses self-determination and hope as it relates to recovery. It is frequently used as an outcome measure for program evaluations. It is a 20-item self-report measure. Items are scored on a 5-point Likert scale and range from strongly agree to strongly disagree
Time frame: Baseline, after 3 months, after 6 months
Change of social support
The MOS Social Support survey: a 19-item measure with 4 support scales (Emotional/Informational, Tangible, Affectionate, and Positive Social Interaction) and an overall functional social support index that has been shown to have good reliability and validity.
Time frame: Baseline, after 3 months, after 6 months
Plan to share: Yes — All participants in the study will be required to complete informed consent forms which will include a clause about data preservation and sharing. Subjects will be assured that their identity will be protected and that no personally identifiable information (PII) will be disclosed as part of any data sharing. All data will be stored on Temple University's password protected, HIPAA-approved secure data server. However, because not all investigators who will need access to the data are at Temple, deidentified, anonymized data may be shared with other investigators via a secure file transfer system. All data in the study transferred between Temple University and collaborating institutions will be transferred through TUSafeSend using data encryption by way of a secure socket transfer protocol. TUSafeSend provides a secure method for transferring files containing confidential or other sensitive information, including HIPAA authorized data with PHI or PII.
Started Oct 2024 (actual). Primary completion is estimated for Jul 2027, 33 months after the start.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 33 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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