Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
15 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
20
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: BRISK Study Coordinator
- Numero di telefono: 617-643-9406
- Email: brisk@mgb.org
Luoghi di studio
-
-
Massachusetts
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Boston, Massachusetts, Stati Uniti, 02114
- Reclutamento
- Massachusetts General Hospital
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Contatto:
- BRISK Study Coordinator
- Numero di telefono: 617-643-9406
- Email: brisk@mgb.org
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mean Total Score Treatment Credibility
Lasso di tempo: 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.
|
After session 1 of intervention, an average of 1 week after baseline
|
|
Mean Total Score Client Satisfaction Questionnaire
Lasso di tempo: 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
|
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Percentage of Eligible Participants Enrolled
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 4 weeks after post-intervention
|
Number of adverse events related to participation in the study.
|
4 weeks after post-intervention
|
|
Treatment Acceptability Survey
Lasso di tempo: 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
|
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Percentage of Participants Meeting Participant Comprehension Criterion
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient Health Questionnaire-9
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
|
University of Washington Resilience Scale Short Form
Lasso di tempo: 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
Lasso di tempo: 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
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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Re-hospitalization
Lasso di tempo: 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
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Evan Plys, PhD, Massachusetts General Hospital
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 novembre 2025
Completamento primario (Stimato)
1 ottobre 2026
Completamento dello studio (Stimato)
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
9 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 giugno 2026
Primo Inserito (Effettivo)
17 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024P001945B
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .