LonelinessN2BN RCTNCT06510439
Need to be Needed (N2BN) Intervention
A study testing Need to Be Needed Intervention in people with Loneliness and Social Isolation, run by Temple University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Loneliness, Social Isolation
- What is being tested?
- Need to Be Needed Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 31 May 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tabea Neumann, M.Sc contact
United States1 site, 1 recruiting
- Recruiting
Hall Mercer
Philadelphia, Pennsylvania, 19106
Steven Niederriter, MBA, 215.829.5575, steven.niederriter@pennmedicine.upenn.edu
About this study
Official title: Randomized, Controlled Trial of Need to be Needed (N2BN) Intervention to Improve Social Connection, Reduce Social Isolation and Loneliness
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.
Read the detailed description
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.
- Conditions
- Loneliness, Social Isolation
- Being tested
- Need to Be Needed Intervention, Active Control Group
- Keywords
- mattering, loneliness, social isolation, need to be needed, neededness, volunteering
- Medical subject headings
- Social Isolation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Need to Be Needed InterventionBehavioural
Also called N2BN Intervention
Interventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention.
Active Control GroupOther
Weekly non-directive listening support
| Study group | Role | What they receive |
|---|---|---|
| Need to be Needed Intervention | Experimental | 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. Receives: Behavioral: Need to Be Needed Intervention |
| Active control group | Active comparator | 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. Receives: Other: Active Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Demographic Background
Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, after 3 months, after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start7 Oct 2024
- Primary completion30 Jul 2027 (estimated)
- Study completion31 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510439
- Sponsor's protocol ID
- 90DPCp0011-01-00
- Other IDs
- 31409
- Acronym
- N2BN RCT
- Status last verified
- Jan 2026
- First submitted
- 14 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Hare-Duke L, Dening T, Oliveira D, Dewa R, Slade M. Social connectedness in adults with mental disorders: ecological validation of a conceptual framework for novel complex interventions. J Ment Health. 2021 Jun;30(3):333-340. doi: 10.1080/09638237.2021.1875409. Epub 2021 Feb 1.
PubMed 33522341Prilleltensky I. Mattering at the Intersection of Psychology, Philosophy, and Politics. Am J Community Psychol. 2020 Mar;65(1-2):16-34. doi: 10.1002/ajcp.12368. Epub 2019 Aug 13.
PubMed 31407358Snethen G, McCormick BP, Van Puymbroeck M. Community involvement, planning and coping skills: pilot outcomes of a recreational-therapy intervention for adults with schizophrenia. Disabil Rehabil. 2012;34(18):1575-84. doi: 10.3109/09638288.2011.650315. Epub 2012 Feb 6.
PubMed 22303816Kim J, Morgul K. Long-term consequences of youth volunteering: Voluntary versus involuntary service. Soc Sci Res. 2017 Sep;67:160-175. doi: 10.1016/j.ssresearch.2017.05.002. Epub 2017 May 13.
PubMed 28888284Wong YJ, Owen J, Gabana NT, Brown JW, McInnis S, Toth P, Gilman L. Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial. Psychother Res. 2018 Mar;28(2):192-202. doi: 10.1080/10503307.2016.1169332. Epub 2016 May 3.
PubMed 27139595O'Connell BH, O'Shea D, Gallagher S. Feeling Thanks and Saying Thanks: A Randomized Controlled Trial Examining If and How Socially Oriented Gratitude Journals Work. J Clin Psychol. 2017 Oct;73(10):1280-1300. doi: 10.1002/jclp.22469. Epub 2017 Mar 6.
PubMed 28263399
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Need to be Needed (N2BN) Intervention to Improve Social Connection, Reduce Social Isolation and Loneliness
- ClinicalTrials.gov ID
- NCT06510439
- Acronym / sponsor ID
- N2BN RCT / 90DPCp0011-01-00
- Conditions
- Loneliness, Social Isolation
- Keywords
- mattering, loneliness, social isolation, need to be needed, neededness, volunteering
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 31 May 2035 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Need to be Needed Intervention | Experimental | Behavioral: 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 control group | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Need to Be Needed InterventionAlso: N2BN InterventionInterventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention. | Behavioural | Need to be Needed Intervention |
| Active Control GroupWeekly non-directive listening support | Other | Active control group |
Primary outcome
Change of Demographic Background
Time frame: baseline, after 3-months, after 6-months
Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status
Change of Neighborhood Social Climate Scale from Housing Environment Survey
Time frame: baseline, after 3-months, after 6-months
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
Change of Social Network
Time frame: baseline, after 3-months, after 6-months
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.
Change of sense of mattering
Time frame: baseline, after 3-months, after 6-months
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).
Change of sense of loneliness
Time frame: baseline, after 3 months, after 6 months
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)
Change of sense of loneliness
Time frame: baseline, after 3 months, after 6 months
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)
Change of depressive symptoms
Time frame: baseline, after 3 months, after 6 months
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
Change of sense of emptiness
Time frame: baseline, after 3 months, after 6 months
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.
Change of community participation
Time frame: Baseline, after 3 months, after 6 months
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.
Change of health outcome
Time frame: Baseline, after 3 months, after 6 months
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.
Change of perceived stigma
Time frame: Baseline, after 3 months, after 6 months
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.
Change of perceived acts of kindess
Time frame: Baseline, after 3 months, after 6 months
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).
Change of perceived gratitude
Time frame: Baseline, after 3 months, after 6 months
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.
Change of overall well being
Time frame: Baseline, after 3 months, after 6 months
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.
Change of recovery assessment
Time frame: Baseline, after 3 months, after 6 months
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
Change of social support
Time frame: Baseline, after 3 months, after 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 33522341Hare-Duke L, Dening T, Oliveira D, Dewa R, Slade M. Social connectedness in adults with mental disorders: ecological validation of a conceptual framework for novel complex interventions. J Ment Health. 2021 Jun;30(3):333-340. doi: 10.1080/09638237.2021.1875409. Epub 2021 Feb 1.
- Background: PubMed 31407358Prilleltensky I. Mattering at the Intersection of Psychology, Philosophy, and Politics. Am J Community Psychol. 2020 Mar;65(1-2):16-34. doi: 10.1002/ajcp.12368. Epub 2019 Aug 13.
- Background: PubMed 22303816Snethen G, McCormick BP, Van Puymbroeck M. Community involvement, planning and coping skills: pilot outcomes of a recreational-therapy intervention for adults with schizophrenia. Disabil Rehabil. 2012;34(18):1575-84. doi: 10.3109/09638288.2011.650315. Epub 2012 Feb 6.
- Background: PubMed 28888284Kim J, Morgul K. Long-term consequences of youth volunteering: Voluntary versus involuntary service. Soc Sci Res. 2017 Sep;67:160-175. doi: 10.1016/j.ssresearch.2017.05.002. Epub 2017 May 13.
- Background: PubMed 27139595Wong YJ, Owen J, Gabana NT, Brown JW, McInnis S, Toth P, Gilman L. Does gratitude writing improve the mental health of psychotherapy clients? Evidence from a randomized controlled trial. Psychother Res. 2018 Mar;28(2):192-202. doi: 10.1080/10503307.2016.1169332. Epub 2016 May 3.
- Background: PubMed 28263399O'Connell BH, O'Shea D, Gallagher S. Feeling Thanks and Saying Thanks: A Randomized Controlled Trial Examining If and How Socially Oriented Gratitude Journals Work. J Clin Psychol. 2017 Oct;73(10):1280-1300. doi: 10.1002/jclp.22469. Epub 2017 Mar 6.
- N2BN informationLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tabea Neumann, M.Sc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Need to Be Needed Intervention in people with Loneliness and Social Isolation, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bryan Mccormick, PhD (1-215-204-6817, bryan.mccormick@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Demographic Background (time frame: baseline, after 3-months, after 6-months). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510439, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.