Need to be Needed (N2BN) Intervention
NCT Number: NCT06510439
Acronym: N2BN RCT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Loneliness|Social Isolation
Interventions: BEHAVIORAL: Need to Be Needed Intervention
Sponsor: Temple University
Collaborators: National Institute on Disability, Independent Living, and Rehabilitation Research
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07
Completion Date: 2035-05

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 12-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 6 months, and at the end of the 12-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.

Primary Outcome Measures: 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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6-months, after 12-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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 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 6 months, after 12 months