Randomized, Controlled Trial of Need to be Needed (N2BN) Intervention to Improve Social Connection, Reduce Social Isolation and Loneliness
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of Demographic Background
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Change of Demographic Background
时间窗: baseline, after 6-months, after 12-months
Standard personal characteristics will be assessed via intake interview. Demographic items will include 11 items identifying employment, income, marital status
Change of health outcome
时间窗: Baseline, after 6 months, after 12 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 acts of kindess
时间窗: Baseline, after 6 months, after 12 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 Neighborhood Social Climate Scale from Housing Environment Survey
时间窗: baseline, after 6-months, after 12-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
时间窗: baseline, after 6-months, after 12-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
时间窗: baseline, after 6-months, after 12-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 recovery assessment
时间窗: Baseline, after 6 months, after 12 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 depressive symptoms
时间窗: baseline, after 6-months, after 12-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 perceived stigma
时间窗: Baseline, after 6 months, after 12 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 sense of emptiness
时间窗: baseline, after 6-months, after 12-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
时间窗: Baseline, after 6 months, after 12 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 perceived gratitude
时间窗: Baseline, after 6 months, after 12 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
时间窗: Baseline, after 6 months, after 12 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 social support
时间窗: Baseline, after 6 months, after 12 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.
Change of sense of loneliness
时间窗: baseline, after 6-months, after 12-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)
次要结局
未报告次要终点