Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
2026년 6월 15일 업데이트: 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
20
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: BRISK Study Coordinator
- 전화번호: 617-643-9406
- 이메일: brisk@mgb.org
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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연락하다:
- BRISK Study Coordinator
- 전화번호: 617-643-9406
- 이메일: brisk@mgb.org
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Total Score Treatment Credibility
기간: After session 1 of intervention, an average of 1 week after baseline
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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
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Mean Total Score Client Satisfaction Questionnaire
기간: Post intervention, an average of 4 weeks after baseline
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3-item self-report measure assessing patient satisfaction with the program.
Higher total scores (min = 3, max = 12) indicate greater satisfaction.
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Post intervention, an average of 4 weeks after baseline
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Percentage of Eligible Participants Enrolled
기간: Post intervention, an average of 4 weeks after baseline
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Percentage of eligible approached individuals that are enrolled into the study.
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Post intervention, an average of 4 weeks after baseline
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Percentage of Participants with Missing Data
기간: 4 weeks after post-intervention
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Percentage of all participants with no measure fully missing at 4-week follow-up.
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4 weeks after post-intervention
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Attendance Rate
기간: Post intervention, an average of 4 weeks after baseline
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Percentage of participants completing 4/6 sessions of the intervention.
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Post intervention, an average of 4 weeks after baseline
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Clinician Fidelity
기간: Post intervention, an average of 4 weeks after baseline
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Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.
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Post intervention, an average of 4 weeks after baseline
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Number of Adverse Events
기간: 4 weeks after post-intervention
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Number of adverse events related to participation in the study.
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4 weeks after post-intervention
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Treatment Acceptability Survey
기간: Post intervention, an average of 4 weeks after baseline
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Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).
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Post intervention, an average of 4 weeks after baseline
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Percentage of Participants Meeting Participant Comprehension Criterion
기간: Post intervention, an average of 4 weeks after baseline
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Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)
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Post intervention, an average of 4 weeks after baseline
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Health Questionnaire-9
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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9-item self-report measure of depression symptoms.
Higher scores (min=0, max=27) indicate greater depressive symptoms.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Selection, Optimization, and Compensation (SOC) in Everyday Use
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Committed Action Questionnaire
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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General Anxiety Disorder-7
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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7-item self-report measure of anxiety symptoms.
Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Euro QoL-5D 5L
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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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
기간: Post intervention, an average of 4 weeks after baseline
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4-item self-report of nursing facility satisfaction.
Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
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Post intervention, an average of 4 weeks after baseline
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University of Washington Resilience Scale Short Form
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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4-item self-report of an individual's perceived resilience.
Summed scores will be converted to T-scores using a conversion table.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Psychotropic medication use
기간: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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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
기간: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Resident re-hospitalization during the study period
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Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Evan Plys, PhD, Massachusetts General Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 11월 17일
기본 완료 (추정된)
2026년 10월 1일
연구 완료 (추정된)
2026년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .