Need to be Needed (N2BN) Intervention

NCT06510439 | Recruiting

• 2 other identifiers: 90DPCp0011-01-0031409
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (16)

• Change of Demographic Background

  Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status

  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

  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.

  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).

  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)

  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)

  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

  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.

  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.

  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.

  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.

  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).

  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.

  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.

  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

  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.

  Baseline, after 3 months, after 6 months

Study Arms (2)

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.

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.

Other: Active Control Group

Interventions

Need to Be Needed Intervention BEHAVIORAL

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

Need to be Needed Intervention

Active Control Group OTHER

Weekly non-directive listening support

Active control group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Temple University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Hall Mercer

Philadelphia, Pennsylvania, 19106, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 33522341 BACKGROUND

• Prilleltensky 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.

  PMID: 31407358 BACKGROUND

• Snethen 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.

  PMID: 22303816 BACKGROUND

• Kim 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.

  PMID: 28888284 BACKGROUND

• Wong 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.

  PMID: 27139595 BACKGROUND

• O'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.

  PMID: 28263399 BACKGROUND

Related Links

• N2BN information

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Central Study Contacts

Bryan Mccormick, PhD

CONTACT

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

Tabea Neumann, M.Sc

CONTACT

tabea.neumann@temple.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator and research assistant completing baseline, mid-point and end-point interview are blind to treatment allocation. Data analyst will be blind to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 19, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): May 31, 2035
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)