Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
15 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
20
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: BRISK Study Coordinator
- Número de telefone: 617-643-9406
- E-mail: brisk@mgb.org
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Recrutamento
- Massachusetts General Hospital
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Contato:
- BRISK Study Coordinator
- Número de telefone: 617-643-9406
- E-mail: brisk@mgb.org
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean Total Score Treatment Credibility
Prazo: 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
Prazo: 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.
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Post intervention, an average of 4 weeks after baseline
|
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Percentage of Eligible Participants Enrolled
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
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Number of Adverse Events
Prazo: 4 weeks after post-intervention
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Number of adverse events related to participation in the study.
|
4 weeks after post-intervention
|
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Treatment Acceptability Survey
Prazo: 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).
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Post intervention, an average of 4 weeks after baseline
|
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Percentage of Participants Meeting Participant Comprehension Criterion
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Health Questionnaire-9
Prazo: 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
Prazo: 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).
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Committed Action Questionnaire
Prazo: 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).
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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
Prazo: 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
|
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Euro QoL-5D 5L
Prazo: 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
Prazo: 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).
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Post intervention, an average of 4 weeks after baseline
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University of Washington Resilience Scale Short Form
Prazo: 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
Prazo: 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
Prazo: 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
|
Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Evan Plys, PhD, Massachusetts General Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de novembro de 2025
Conclusão Primária (Estimado)
1 de outubro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
9 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2024P001945B
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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