Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
15 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: BRISK Study Coordinator
- Numéro de téléphone: 617-643-9406
- E-mail: brisk@mgb.org
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts General Hospital
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Contact:
- BRISK Study Coordinator
- Numéro de téléphone: 617-643-9406
- E-mail: brisk@mgb.org
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Total Score Treatment Credibility
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient Health Questionnaire-9
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Evan Plys, PhD, Massachusetts General Hospital
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
17 novembre 2025
Achèvement primaire (Estimé)
1 octobre 2026
Achèvement de l'étude (Estimé)
31 décembre 2026
Dates d'inscription aux études
Première soumission
9 juin 2026
Première soumission répondant aux critères de contrôle qualité
15 juin 2026
Première publication (Réel)
17 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2024P001945B
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Interventions for Stressful Transitions in Later Life (InSTILL) for Individuals
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University of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)ComplétéPerte de poids | Facteur de risque cardiovasculaire | Régime alimentaire, santéÉtats-Unis