Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
2026年6月15日 更新者：Evan Plys、Massachusetts General Hospital
Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents.
The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful.
Participants will join 6 bi-weekly sessions of the InSTILL program.
Participants will complete assessments at three timepoints (all) and a brief-exit interview.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
20
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：BRISK Study Coordinator
- 电话号码：617-643-9406
- 邮箱：brisk@mgb.org
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02114
- 招聘中
- Massachusetts General Hospital
-
接触：
- BRISK Study Coordinator
- 电话号码：617-643-9406
- 邮箱：brisk@mgb.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
- 5+ chronic conditions based on Elixhauser Comorbidity Index
- Aged ≥ 18 years
- Able and willing to participate in the study
Exclusion Criteria:
- Intended length of SNF stay < 7 days
- More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
- Participant's roommate is already enrolled in study/intervention
- High risk of suicide/active documented SI per the PHQ-9, item 9 or otherwise
- Participation in newly initiated psychotherapy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：InSTILL for Individuals
Participants in this arm will participate in the Interventions for Stressful Transitions in Later Life (InSTILL), a behavioral health intervention tailored to the needs of short stay nursing facility residents.
InSTILL for Individuals includes 6 sessions (2x per week for about 3 weeks) delivered in person or remotely.
|
The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents experiencing elevated levels of psychological distress.
The intervention is designed to improve life management skills and emotion regulation skill with the goal of reducing depression symptoms.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Total Score Treatment Credibility
大体时间：After session 1 of intervention, an average of 1 week after baseline
|
3-item self-report measure of participant's belief regarding how helpful the intervention will be for them.
Higher scores (min = 0, max = 30) scores indicate greater credibility.
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After session 1 of intervention, an average of 1 week after baseline
|
|
Mean Total Score Client Satisfaction Questionnaire
大体时间：Post intervention, an average of 4 weeks after baseline
|
3-item self-report measure assessing patient satisfaction with the program.
Higher total scores (min = 3, max = 12) indicate greater satisfaction.
|
Post intervention, an average of 4 weeks after baseline
|
|
Percentage of Eligible Participants Enrolled
大体时间：Post intervention, an average of 4 weeks after baseline
|
Percentage of eligible approached individuals that are enrolled into the study.
|
Post intervention, an average of 4 weeks after baseline
|
|
Percentage of Participants with Missing Data
大体时间：4 weeks after post-intervention
|
Percentage of all participants with no measure fully missing at 4-week follow-up.
|
4 weeks after post-intervention
|
|
Attendance Rate
大体时间：Post intervention, an average of 4 weeks after baseline
|
Percentage of participants completing 4/6 sessions of the intervention.
|
Post intervention, an average of 4 weeks after baseline
|
|
Clinician Fidelity
大体时间：Post intervention, an average of 4 weeks after baseline
|
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.
|
Post intervention, an average of 4 weeks after baseline
|
|
Number of Adverse Events
大体时间：4 weeks after post-intervention
|
Number of adverse events related to participation in the study.
|
4 weeks after post-intervention
|
|
Treatment Acceptability Survey
大体时间：Post intervention, an average of 4 weeks after baseline
|
Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).
|
Post intervention, an average of 4 weeks after baseline
|
|
Percentage of Participants Meeting Participant Comprehension Criterion
大体时间：Post intervention, an average of 4 weeks after baseline
|
Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)
|
Post intervention, an average of 4 weeks after baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Health Questionnaire-9
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
9-item self-report measure of depression symptoms.
Higher scores (min=0, max=27) indicate greater depressive symptoms.
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Selection, Optimization, and Compensation (SOC) in Everyday Use
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life.
Items are averaged for a composite score, with higher scores indicate greater SOC strategy use (Range = 1-6).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Committed Action Questionnaire
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
8-item self-report measure of pursuit of valued goals despite challenges and difficulties.
Higher scores indicate greater use and effectiveness of emotional regulation skills (Range = 0-48).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
General Anxiety Disorder-7
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
7-item self-report measure of anxiety symptoms.
Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Euro QoL-5D 5L
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
6-item self-report measure of subjective health-related quality of life.
Higher scores indicate worse health-related quality of life (Range = 5-25).
The scale also includes a separately scored single-item global health indicator, asked on a 0-100 scale with higher scores indicate higher subjective health-related quality of life.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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COREQ
大体时间：Post intervention, an average of 4 weeks after baseline
|
4-item self-report of nursing facility satisfaction.
Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
|
Post intervention, an average of 4 weeks after baseline
|
|
University of Washington Resilience Scale Short Form
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
4-item self-report of an individual's perceived resilience.
Summed scores will be converted to T-scores using a conversion table.
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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Psychotropic medication use
大体时间：Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
Chart or self reported psychotropic medication use.
Patients will self-report changes to medication, including dosage, at post-intervention and follow-up
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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Re-hospitalization
大体时间：Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
Resident re-hospitalization during the study period
|
Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Evan Plys, PhD、Massachusetts General Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年11月17日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年12月31日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月17日
研究记录更新
最后更新发布 (实际的)
2026年6月17日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.