Social Prescribing and Relationship Cognitive Strategies (SPARCS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Adapted Client Satisfaction Questionnaire - Intervention arms only
研究概览
简要总结
The study team is testing the acceptability and feasibility of two treatments for improving loneliness: Social Prescribing and Brief Cognitive Therapy.
For this pilot study, the study team have adapted these treatments for Collaborative Care and are studying whether these are practical and well-received by patients that might use them.
详细描述
The study will take place at 2 University of Michigan sites.
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
- Single (Outcomes Assessor)
盲法说明
To the extent possible, the assessor will be blinded. The study team will track any instances where an assessor becomes unblinded to a participant's arm assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Screen positive for either or both of the following during routine clinic screening:
- •Social isolation in the past 6 months, according to the screening question "How often do you feel isolated from others?"
- •Suicidal ideation in the past 12 months, according to the 9th item of the Patient Health Questionnaire (HQ-9) (per protocol)
- •Loneliness, according to the 3-item version of the University of California, Los Angeles (UCLA) Loneliness Scale (per protocol)
- •Are currently receiving or are able to initiate Collaborative Care Management at to participant's study site
排除标准
- •Currently receiving or have an active referral for specialty mental health or substance use disorder treatment outside of primary care
- •Neurocognitively impaired according to chart diagnosis, self-report on the Eligibility Screening Survey, or inability to answer comprehension check questions during the Informed Consent process (per protocol)
- •Unable to participate in the interventions and research assessments due to planned travel or limited phone access (e.g., does not own phone)
- •Terminally ill or receiving of palliative care with less than 6 months life expectancy
研究组 & 干预措施
Enhanced Usual Care control group
Participants will receive an informational booklet on improving loneliness and may initiate or continue Collaborative Care for other conditions on a not research basis.
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
干预措施: Enhanced Usual Care (Other)
Brief Cognitive Therapy then Social Prescribing
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
干预措施: Brief Cognitive Therapy (Behavioral)
Brief Cognitive Therapy then Social Prescribing
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
干预措施: Social Prescribing (Behavioral)
Social Prescribing then Brief Cognitive Therapy
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
干预措施: Brief Cognitive Therapy (Behavioral)
Social Prescribing then Brief Cognitive Therapy
Besides the baseline survey participants will also take 2 more surveys, 3-months and 6-months from the first survey. Those surveys will ask similar questions and will take about 45 minutes to complete. These can be done online or over the phone with a researcher that will not know the treatment arm assignment.
干预措施: Social Prescribing (Behavioral)
结局指标
主要结局
Adapted Client Satisfaction Questionnaire - Intervention arms only
时间窗: 3 and 6 months
This is an 8-item self-report survey which assesses participant satisfaction with services received. SCORING: Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Intervention Helpfulness - Intervention Arms Only
时间窗: 6 months
This is a 9-item, self-report study-specific questionnaire that assesses how much participants were helped by the combined study interventions on various cognitive and behavioral factors that impact loneliness. Questions use a 6-point Likert scale where 0 = "Not applicable/Did not work on this" and 6 = "Made things a lot better." SCORING: Scores will range from 0 to 45, with higher scores indicating greater helpfulness.
UCLA Loneliness Scale
时间窗: Baseline, 3 and 6 months
This consists of 20 items using 4-point Likert-type response anchors from never feel this way (0) - often feel this way (3) (9 items are reverse coded) for a score range from 10 to 80.
Computer Adaptive Testing - Suicide Scale (CAT-SS)
时间窗: Baseline, 3 and 6 months
The CAT-SS is based on multidimensional item response theory (MIRT). Within computer adaptive testing, an individuals' initial item responses are used to determine a provisional estimate of their standing on the measured trait to be used for subsequent item selection. MIRT weighs more severe items more heavily than less severe items in deriving a test score, and provides an estimate of uncertainty that can be used to assess the significance of change for an individual. The measure adaptively selects an average of 10 items per administration from a large bank of approximately 1,000 items. Instead of fixing the items and allowing the precision of measurement to vary, this measure fixes the precision of measurement and allow the items to vary. As a result, measurement is more precise and less burdensome compared with fixed-item standardized measures of suicidal ideation.
Feasibility will be measured by the recruitment goal of 60 participants
时间窗: 15 months (recruitment period)
Feasibility will be measured by completion rates of follow-up assessments at 3 and 6 months
时间窗: 3 and 6 months
The target for this goal = 75%.
次要结局
- Beck Scale for Suicidal Ideation (BSS)(Baseline, 12 and 24 weeks)
- Interpersonal Needs Questionnaire (INQ)(Baseline, 12 and 24 weeks)
- Interpersonal Support Evaluation List (ISEL)(Baseline, 12 and 24 weeks)
- Patient Health Questionnaire (PHQ-9)(Baseline, 12 and 24 weeks)
- Generalized Anxiety Disorder 7 (GAD-7)(Baseline, 12 and 24 weeks)
- Short Form Survey (SF-12)(Baseline, 12 and 24 weeks)
- Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q-SF)(Baseline, 12 and 24 weeks)
研究者
Paul Pfeiffer
Professor of Psychiatry
University of Michigan